The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.
Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)
The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action.
The giving of drugs, chemicals, or other substances by mouth.
A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.
An antiepileptic agent related to the barbiturates; it is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite. Adverse effects are reported to be more frequent than with PHENOBARBITAL. (From Martindale, The Extra Pharmacopoeia, 30th ed, p309)
A metabolite of primidone.
An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.
An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.
The application of scientific knowledge or technology to the field of radiology. The applications center mostly around x-ray or radioisotopes for diagnostic and therapeutic purposes but the technological applications of any radiation or radiologic procedure is within the scope of radiologic technology.
A specialty field of radiology concerned with diagnostic, therapeutic, and investigative use of radioactive compounds in a pharmaceutical form.
Health care workers specially trained and licensed to assist and support the work of health professionals. Often used synonymously with paramedical personnel, the term generally refers to all health care workers who perform tasks which must otherwise be performed by a physician or other health professional.
Hospital department responsible for the administration and management of nuclear medicine services.
SNARE binding proteins that facilitate the ATP hydrolysis-driven dissociation of the SNARE complex. They are required for the binding of N-ETHYLMALEIMIDE-SENSITIVE PROTEIN (NSF) to the SNARE complex which also stimulates the ATPASE activity of NSF. They are unrelated structurally to SNAP-25 PROTEIN.
Examination of any part of the body for diagnostic purposes by means of X-RAYS or GAMMA RAYS, recording the image on a sensitized surface (such as photographic film).
Tumors, cancer or other neoplasms produced by exposure to ionizing or non-ionizing radiation.
A tough, malleable, iron-based alloy containing up to, but no more than, two percent carbon and often other metals. It is used in medicine and dentistry in implants and instrumentation.
Behavioral or attitudinal compliance with recognized social patterns or standards.
A standardized nomenclature for clinical drugs and drug delivery devices. It links its names to many of the drug vocabularies commonly used in pharmacy management.
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
Official records of individual deaths including the cause of death certified by a physician, and any other required identifying information.
Large vessels propelled by power or sail used for transportation on rivers, seas, oceans, or other navigable waters. Boats are smaller vessels propelled by oars, paddles, sail, or power; they may or may not have a deck.
To be used for articles pertaining to medical activities carried out by personnel in institutions which are administered by a religious organization.
The religion stemming from the life, teachings, and death of Jesus Christ: the religion that believes in God as the Father Almighty who works redemptively through the Holy Spirit for men's salvation and that affirms Jesus Christ as Lord and Savior who proclaimed to man the gospel of salvation. (From Webster, 3d ed)
Individual components of atoms, usually subatomic; subnuclear particles are usually detected only when the atomic nucleus decays and then only transiently, as most of them are unstable, often yielding pure energy without substance, i.e., radiation.
The bestowing of tangible or intangible benefits, voluntarily and usually without expectation of anything in return. However, gift giving may be motivated by feelings of ALTRUISM or gratitude, by a sense of obligation, or by the hope of receiving something in return.
The heath plant family of the order Ericales, subclass Dilleniidae, class Magnoliopsida that are generally shrubs or small trees. Leaves are alternate, simple, and leathery; flowers are symmetrical with a 4- or 5-parted corolla of partly fused petals.
Travel by a group of physicians for the purpose of making a special study or undertaking a special project of short-term duration.
The continuous sequential physiological and psychological maturing of an individual from birth up to but not including ADOLESCENCE.
The branch of psychology concerned with psychological methods of recognizing and treating behavior disorders.
The study of normal and abnormal behavior of children.
Individuals enrolled in a school or formal educational program.
Individuals enrolled in a school of medicine or a formal educational program in medicine.
The science dealing with the study of mental processes and behavior in man and animals.
The periodic shedding of the ENDOMETRIUM and associated menstrual bleeding in the MENSTRUAL CYCLE of humans and primates. Menstruation is due to the decline in circulating PROGESTERONE, and occurs at the late LUTEAL PHASE when LUTEOLYSIS of the CORPUS LUTEUM takes place.
The period from onset of one menstrual bleeding (MENSTRUATION) to the next in an ovulating woman or female primate. The menstrual cycle is regulated by endocrine interactions of the HYPOTHALAMUS; the PITUITARY GLAND; the ovaries; and the genital tract. The menstrual cycle is divided by OVULATION into two phases. Based on the endocrine status of the OVARY, there is a FOLLICULAR PHASE and a LUTEAL PHASE. Based on the response in the ENDOMETRIUM, the menstrual cycle is divided into a proliferative and a secretory phase.
A subfamily in the family ATELIDAE, comprising three genera: woolly monkeys (Lagothrix), spider monkeys (Ateles), and woolly spider monkeys (Brachyteles).
A family of New World monkeys in the infraorder PLATYRRHINI, consisting of nine subfamilies: ALOUATTINAE; AOTINAE; Atelinae; Callicebinae; CALLIMICONINAE; CALLITRICHINAE; CEBINAE; Pithecinae; and SAIMIRINAE. They inhabit the forests of South and Central America, comprising the largest family of South American monkeys.
An infraorder of New World monkeys, comprised of the families AOTIDAE; ATELIDAE; CEBIDAE; and PITHECIIDAE. They are found exclusively in the Americas.
A genus of the subfamily ALOUATTINAE, family ATELIDAE, inhabiting the forests of Central and South America. Howlers travel in groups and define their territories by howling accompanied by vigorously shaking and breaking branches.
Works containing information articles on subjects in every field of knowledge, usually arranged in alphabetical order, or a similar work limited to a special field or subject. (From The ALA Glossary of Library and Information Science, 1983)
Neurons whose primary neurotransmitter is DOPAMINE.
One of the catecholamine NEUROTRANSMITTERS in the brain. It is derived from TYROSINE and is the precursor to NOREPINEPHRINE and EPINEPHRINE. Dopamine is a major transmitter in the extrapyramidal system of the brain, and important in regulating movement. A family of receptors (RECEPTORS, DOPAMINE) mediate its action.
The basic cellular units of nervous tissue. Each neuron consists of a body, an axon, and dendrites. Their purpose is to receive, conduct, and transmit impulses in the NERVOUS SYSTEM.
The middle of the three primitive cerebral vesicles of the embryonic brain. Without further subdivision, midbrain develops into a short, constricted portion connecting the PONS and the DIENCEPHALON. Midbrain contains two major parts, the dorsal TECTUM MESENCEPHALI and the ventral TEGMENTUM MESENCEPHALI, housing components of auditory, visual, and other sensorimoter systems.
The black substance in the ventral midbrain or the nucleus of cells containing the black substance. These cells produce DOPAMINE, an important neurotransmitter in regulation of the sensorimotor system and mood. The dark colored MELANIN is a by-product of dopamine synthesis.
A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75)
An enzyme that catalyzes the conversion of L-tyrosine, tetrahydrobiopterin, and oxygen to 3,4-dihydroxy-L-phenylalanine, dihydrobiopterin, and water. EC 1.14.16.2.

Pharmacokinetics of bendazac lysine in 10 Chinese young men. (1/478)

AIM: To compare the pharmacokinetics of domestic and imported tablets of bendazao lysine (BL). METHODS: A single oral dose of 500 mg BL of this 2 kinds of tablets was given to 10 Chinese volunteers of Han nationality in a randomized crossover study. Plasma levels were determined with HPLC-UV method. Data were analyzed automatically by using a CAPP program on microcomputer. RESULTS: The plasma concentration-time curve was fitted to 2-compartment open model, and the major pharmacokinetic parameters of domestic and imported BL tablets were shown respectively as following: Cmax 66 +/- 16 and 65 +/- 8 mg.L-1; Tmax 0.98 +/- 0.22 and 0.98 +/- 0.21 h; T1/2 beta 6.2 +/- 1.8 and 6.2 +/- 1.7 h; AUC 335 +/- 47 and 337 +/- 58 mg.h.L-1. There was no significant difference between domestic and imported tablets. The bioavailability of the domestic vs that of the imported tablet was 99 +/- 12%. The unchanged BL in urine were about 5.4% and 5.6% respectively of the dosage in 24 h after a single oral dose. CONCLUSION: The two kinds of tablets had the same biological effects.  (+info)

Generic drug product equivalence: current status. (2/478)

This activity is designed for healthcare professionals involved in the selection of multisource drug products. GOAL: To understand the basis for approval of generic drug products by the Food and Drug Administration. OBJECTIVES: 1. Identify the criteria employed by the Food and Drug Administration to approve generic drug products. 2. Discuss controversial issues that have been raised relative to generic drug products. 3. Identify narrow therapeutic index drugs. 4. Describe the different types of bioequivalence studies that are required by the Food and Drug Administration. 5. Discuss the responsibilities underlying the selection of multisource drug products by healthcare professionals.  (+info)

Oral bioequivalence of three ciprofloxacin formulations following single-dose administration: 500 mg tablet compared with 500 mg/10 mL or 500 mg/5 mL suspension and the effect of food on the absorption of ciprofloxacin oral suspension. (3/478)

The oral bioequivalence and tolerability of two ciprofloxacin formulations (tablet and suspension) and the effect of food on the absorption of ciprofloxacin oral suspension were investigated. Sixty-eight young, healthy male subjects participated in two separate, randomized, crossover studies. In study 1, ciprofloxacin as a single 500 mg tablet or as 500 mg/10 mL oral suspension was administered in a fasted state on day 1. In study 2, subjects participated in a three-way crossover study in which ciprofloxacin suspension was administered as 500 mg/10 mL in a fasted state, or 500 mg/10 mL with food, or 500 mg/5 mL in a fasted state. Plasma ciprofloxacin concentrations were measured by high-performance liquid chromatography. Standard pharmacokinetic parameters were estimated using non-compartmental methods. In study 1, geometric mean Cmax values of ciprofloxacin following the single 500 mg tablet and 500 mg/10 mL suspension doses were 2.36 and 2.18 mg/L, respectively; corresponding geometric mean t(max) values were 1.1 and 1.6 h, respectively. Geometric mean AUC(0-infinity) values were 12.0 and 11.8 mg x h/L, respectively. In study 2, geometric least squares mean Cmax values following ciprofloxacin 500 mg/10 mL and 500 mg/5 mL suspension during fasted conditions were 1.54 and 1.59 mg/L, respectively. Corresponding geometric least squares mean AUC(0-infinity) values were 7.3 and 8.0 mg x h/L. Administration of ciprofloxacin 500 mg/10 mL suspension, in either a fasted or fed state, was not associated with significant changes in Cmax (1.54 mg/L for fasted vs 1.37 mg/L for fed) or AUC(0-infinity) values (7.28 mg x h/L for fasted vs 8.19 mg x h/L for fed). Each ciprofloxacin formulation was well tolerated for the duration of each study. These studies demonstrated bioequivalence between ciprofloxacin 500 mg tablet and two strengths of ciprofloxacin suspension (500 mg/10 mL and 500 mg/5 mL). Bioavailability was unaltered by food.  (+info)

The in vivo assessment of nimesulide cyclooxygenase-2 selectivity. (4/478)

In man, nimesulide selectively inhibits cyclooxygenase-2 (COX-2) with little effect on haemostatic function or gastric prostaglandin formation. It causes significantly less gastrointestinal injury than naproxen, but has anti-inflammatory efficacy similar to that of naproxen and other currently available non-steroidal anti-inflammatory drugs. Naproxen suppressed arachidonic-acid-mediated platelet aggregation, reduced serum thromboxane B2 levels by 98% throughout the treatment period and reduced gastric mucosal prostaglandins (PGE2 and 6-keto-PGF1alpha) production by an average of 80%. This contrasts with nimesulide: platelet aggregation was not significantly affected, thromboxane B2 levels were only 29% lower and the gastric mucosal prostaglandins were inhibited in the order of approximately 20%. During the treatment period, both nimesulide and naproxen significantly inhibited COX-2-dependent PGE2 synthesis in the whole blood; however, naproxen had a lesser effect than nimesulide.  (+info)

Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon(R)) by Pen-injector and syringe. (5/478)

A randomized, single-centre, cross-over study was designed to compare the bioavailability of two pharmaceutical formulations of recombinant human follicle stimulating hormone (recFSH; Puregon(R)): (i) a dissolved cake injected by a normal syringe; and (ii) a ready-for-use solution injected using a device referred to as Puregon(R)Pen. Twenty-two healthy female volunteers underwent one of two administration sequences: Puregon(R)Pen/syringe or syringe/Puregon(R)Pen, by which they received a single subcutaneous dose of recFSH (150 IU). Endogenous gonadotrophin production had been previously suppressed using an oral contraceptive (Lyndiol(R)). Pharmacokinetic parameters characterizing rate [peak concentration (Cmax) and time of peak concentration (tmax)] and extent [area under the curve (AUC) and clearance (CL)] of absorption were obtained from 20 subjects. After injection with both formulations, serum FSH concentrations reached a peak of 3.4 IU/l at 13 h after injection. The elimination half-life was approximately 34 h, irrespective of formulation. A difference of approximately 18% was found between serum FSH concentrations obtained using the two formulations, which was caused by differences between the anticipated and the actual volume injected with the normal syringe. After correction for injection losses by weighing the amount injected with a normal syringe, the two formulations were found to be bioequivalent with respect to Cmax, AUC and CL. For tmax, bioequivalence could not be proven due to high intra-subject variability and broad absorption peaks of FSH. Both methods were well tolerated, local reactions being generally mild and short-lived.  (+info)

Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: a randomized, double-blind, placebo-controlled study. (6/478)

OBJECTIVE: To demonstrate that in patients receiving naproxen for the pain of osteoarthritis (OA), the addition of tramadol will allow a reduction in the naproxen dosage without compromising pain relief. METHODS: This trial consisted of a 5-week open-label run-in and an 8-week double-blind phase. Patients with at least moderate pain (> or =40 mm on a 100-mm visual analog scale) of OA of the knee after a 1-week medication washout were treated with naproxen 500 mg/day for 1 week. Patients whose pain scores were reduced to <20 mm were discontinued. The remaining patients received naproxen 1,000 mg/day for 3 weeks. Tramadol 200 mg/day was added during the third week. Patients were then randomized in a double-blind manner to continue tramadol 200 mg/day or to begin placebo in addition to naproxen. Randomization was stratified based on response to naproxen 1,000 mg/day. During the double-blind phase, the naproxen dose was reduced by 250 mg every 2 weeks. The primary efficacy end point was the minimum effective naproxen dose (MEND). The MEND was defined as 250 mg above the naproxen daily dosage at which pain relief was no longer adequate. Patients discontinuing the double-blind phase of the study for reasons other than lack of efficacy were assigned a MEND equal to the last naproxen dose received. If the effect of treatment between the responder and nonresponder groups was statistically different, the difference in the MEND was assessed separately within the groups. RESULTS: Of 236 patients randomized (mean age 61 years; 147 females), 90 were stratified as naproxen responders and 146 as naproxen nonresponders. There was a significant difference (P = 0.040) in the treatment effect between the naproxen responders and nonresponders, thus demonstrating a difference in the way responders and nonresponders react to a decrease in naproxen dosage after the addition of tramadol. Among naproxen responders, the MEND was significantly lower in patients receiving tramadol (n = 36) than in patients receiving placebo (n = 54), 221 mg versus 407 mg, respectively (P = 0.021). For the naproxen nonresponders, the mean MEND was 419 mg in the tramadol group and 396 mg in the placebo group (P = 0.706). CONCLUSION: In patients with painful OA of the knee responding to naproxen 1,000 mg/day, the addition of tramadol 200 mg/day allows a significant reduction in the dosage of naproxen without compromising pain relief.  (+info)

No benefit of long-term ciprofloxacin treatment in patients with reactive arthritis and undifferentiated oligoarthritis: a three-month, multicenter, double-blind, randomized, placebo-controlled study. (7/478)

OBJECTIVE: To investigate the effect of long-term antibiotic treatment in patients with reactive arthritis (ReA) and undifferentiated oligoarthritis. METHODS: One hundred twenty-six patients were treated with ciprofloxacin (500 mg twice a day) or placebo for 3 months, in a double-blind, randomized study. Of these patients, 104 (48 treated with ciprofloxacin and 56 treated with placebo) were valid for clinical evaluation: 55 were diagnosed as having ReA with a preceding symptomatic urogenic or enteric infection and 49 as having undifferentiated oligoarthritis. These 2 groups were randomized separately. The triggering bacterium was sought by serology and/or culture. The percentage of patients in remission after 3 months of treatment was chosen as the primary efficacy parameter. RESULTS: A triggering bacterium could be identified in 52 patients (50%): Chlamydia trachomatis in 13, Yersinia in 14, and Salmonella in 25. No patient was positive for Campylobacter jejuni or for Shigella. No difference in outcome was found between treatment with ciprofloxacin or placebo in the whole group or in subgroups of patients with ReA or undifferentiated oligoarthritis. No difference was seen in patients with a disease duration <3 months. Ciprofloxacin was not effective in Yersinia- or Salmonella-induced arthritis but seemed to be better than placebo in Chlamydia-induced arthritis. This difference was not significant, however, which might be due to the small sample size. CONCLUSION: Long-term treatment of ReA with ciprofloxacin is not effective; however, it might be useful in the subgroup of patients who have Chlamydia-induced arthritis. This has to be proven in a bigger study focusing on patients with Chlamydia-induced arthritis.  (+info)

A novel formulary: collaboration between health care professionals, seniors, private sector and government in Nova Scotia. (8/478)

A novel formulary has been developed in Nova Scotia with the objective of providing quality treatment with needed medications at affordable cost. Creation of the formulary has involved collaboration among health care professionals, seniors, the Department of Health and pharmaceutical companies. This is the first Canadian formulary to use the Anatomic, Therapeutic, Chemical system. Drug listing is comprehensive rather than exclusive. Colour-coded recommendations on use assist physicians with drug choice. Relative costs are indicated within each therapeutic grouping. Listings indicate drugs approved for reimbursement, interchangeable medications, maximum allowable cost, drug identification number and manufacturer code. Treatment summaries provide brief overviews of therapeutic advice. Updates on new products and new or modified treatment summaries are provided every 6 months. The formulary will be the focus of coordinated educational activities on treatment for seniors and health care professionals.  (+info)

GRANDE-ORTIZ, Miguel et al. Therapeutic equivalence evaluated by in vitro studies of multisource pharmaceutical products: case studies of amoxicillin, doxycycline and fluconazole in Lima, Peru. Rev. perú. med. exp. salud publica [online]. 2019, vol.36, n.1, pp.74-80. ISSN 1726-4634. http://dx.doi.org/10.17843/rpmesp.2019.361.3912.. The objective of the study was to determine the therapeutic equivalence evaluated through in vitro studies of four brands of drugs containing amoxicillin, doxycycline, and fluconazole purchased at pharmaceutical facilities in Metropolitan Lima, and to establish their interchangeability with a reference product (RP). A validated method of visible ultraviolet spectrophotometry was used to determine the dissolution profile. The similarity factor (f2) was used to establish the therapeutic equivalence, being considered equivalent if the values of f2 were between 50 and 100. For doxycycline, the four drugs were equivalent in vitro to the RP; for amoxicillin, only two drugs ...
Scientific, peer-reviewed Dermatology article, indexed with MEDLINE/PubMed: Clinical Equivalence of Conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (Neurotoxin Free From Complexing Proteins - 150 KDa): 2013 Multidisciplinary French Consensus in Aesthetics : Botulinum neurotoxins are the most popular non-surgical treatments for aesthetic indications, but there is uncertainty about whether certain formulations are comparable in efficacy and safety and can be substituted for one another by a simple one to one dose conversion ratio. An expert panel of French practitioners was convened to establish a consensus on the clinical equivalence in efficacy and safety of OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa). The consensus was divided into three sections incorporating a biological, bibliographic and clinical analysis of the two toxins. This included a review of the published data that have directly compared the two toxins for
As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner ...
As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner ...
TY - JOUR. T1 - Bioequivalence assessment of two simvastatin tablets in healthy Taiwanese volunteers. AU - Tseng, Chih Meng. AU - Huang, Chun Chen. AU - Ho, Meng Chun. AU - Chen, Yen An. AU - Shieh, Ying Hua. AU - Chen, I. Kai. PY - 2007/3. Y1 - 2007/3. N2 - The pharmacokinetics and bioequivalence of two tablets of simvastatin, Zolotin and ZOCOR®, were evaluated in 26 healthy male Taiwanese volunteers who reside in Taiwan. The experiments were designed as a randomized, two-sequence, two-period and single-dose crossover study. Blood samples were obtained at 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14 and 24 hr after oral dosing of one tablet. β-hydroxyacid simvastatin concentrations in plasma were analyzed by a validated LC/MS/MS method. The pharmacokinetic parameters were analyzed by non-compartmental analysis. The analysis of variance was carried out using log-transformed AUC0-t, AUC0-∞ and Cmax. The results revealed that the Cmax of Zolotin and ZOCOR® ...
PRESS RELEASE mithra announces positive OUTCOME of myring(TM) COMMERCIAL BATCH bioequivalence study Bioequivalence study performed on commercial Myring (TM) batch produced at Mithra CDMO Data
Part-I of this article entitled Research, Product Development And Production of Biotech Derived Pharmaceuticals has been published in October 2007 issue of this journal. The present article covers therapeutic equivalence of biotechnology derived pharmaceuticals. The objective of writing this article is to assist the Pharma and biotech industry in guiding for establishing therapeutic equivalence of Biotech-Derived Pharmaceuticals which need to be produced in India and exported globally. The honorable finance minister Shri P Chidambaram has given incentives in the current budget for the Research areas, Biotech-Derived Pharmaceuticals being the grey area can benefit from this announcement.
To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period cross-over studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated LC-MS/MS method. Pharmaco-kinetic parameters were derived using a non-compartmental approach. Bioequivalence was evaluated in 69 subjects in the fasting study, and 71 subjects in the fed study. In the fasting study, the 90% CI of Cmax and AUC0-72 were 82.50-90.10 and 92.38-98.60, respectively. Corresponding values in the fed study were 91.82-98.05 and 97.27-100.27. Based on the results, the test product (donepezil) met the US regulatory criteria of bioequivalence relative to the reference product (Aricept®) under
This was a single center, single-dose, randomized, open-label, two-treatment, two-period crossover bioequivalence study designed to evaluate the pharmacokinetics and bioequivalence of morphine sulfate formulations under fed conditions. Normal healthy males and females at least 18 years of age were screened for enrollment into the trial.. Potential subjects who met the eligibility criteria randomly received either oral Morphine Sulfate 60 mg Extended-release tablets or oral MS Contin® 60 mg Controlled-release tablets on Day 1 in Period 1, then, following the washout period, they were dosed on Day 8 in Period 2 with the other treatment. There was a 7-day washout period between dosing. The study drug treatments were administered following the Food and Drug Administration (FDA) high-fat breakfast, which was served after subjects had been fasting for 11 hours. Fasting resumed until 4 hours post-dose for both treatment groups. All enrolled subjects were administered single oral doses of 50 mg of ...
Pharmacodynamic studies are a potential replacement for clinical studies currently required to establish equivalence of generic drugs that are not systemically absorbed, FDA Division of Bioequivalence Director Shrikant Dighe, PhD, told the Regulatory Affairs Professionals Society 12th annual meeting Sept. 28. Pharmacodynamic measurements may be an answer to bioequivalence studies for [drugs] for which there is no absorption in the systemic circulation, Dighe said. Pharmacodynamic measurements have been demonstrated to be sensitive and reproducible in certain cases, and those could be potential methodologies for the [evaluation] of bioequivalence of these non-absorbing products. If adopted, the use of pharmacodynamic studies could make ANDA submissions for products that are not systemically absorbed easier for generic firms. Presently, the agency requires clinical studies showing therapeutic equivalence for such products, with the number of patients required ranging from 60, for products like ...
Ostrowicz, A.; Mikołajczak, Pław.L.; Wierzbicka, M.; Boguradzki, P., 2014: Bioequivalence study of 400 and 100 mg imatinib film-coated tablets in healthy volunteers
Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers Milko Radicioni,1 Chiara Castiglioni,1 Andrea Giori,2 Irma Cupone,3 Valeria Frangione,4 Stefano Rovati4 1CROSS Research S.A., Phase I Unit, Arzo, Switzerland; 2IBSA Farmaceutici Italia, Lodi, Italy; 3Bouty S.p.A., Strada Padana Superiore, Cassina De Pecchi, Italy; 4IBSA Institut Biochimique S.A., Pambio-Noranco, Switzerland Abstract: A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra®) after single-dose administration to 53 healthy male volunteers (aged
PubMed journal article: Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market. Download Prime PubMed App to iPhone, iPad, or Android
This was an open-label, balanced, randomized, two-treatment, four-period, two-sequence,single dose, replicate crossover bioequivalence study in healthy, adult, human, male subjects under fasting conditions.48 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first three hours after dosing ...
This bioequivalence study will compare the efficacy, pharmacokinetics and tolerability of doxorubicin [Janssen Research and Development] in current versus new
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (adalimumab) for use in all indications of the reference medicine, including rheumatoid arthritis, plaque psoriasis, Crohns disease, uveitis and ulcerative colitis.. The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar ...
The U.S. Court of Appeals for the Federal Circuit handed Eli Lilly a victory over that Teva Pharma in upholding an extension of the statutory thirty-month stay under the Hatch-Waxman Act, thus preventing the U.S. Food and Drug Administration from finally approving Tevas Abbreviated New Drug Application (ANDA). Eli Lilly & Co. v. Teva Pharma (09-1071).. The Hatch-Waxman Act requires a pioneer drug manufacturer to notify the FDA of all patents that claim[ ] the drug for which the [NDA] applicant submitted the application. The FDA lists the patents in its Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Under the law, a generic manufacturer infringes a patent by filing an ANDA to obtain approval for a generic drug product claimed by a valid and unexpired patent.. In this case, Lilly holds the approved NDA for raloxifene hydrochloride tablets, which is marketed under the brand name Evista® for the treatment and prevention of postmenopausal osteoporosis. Lilly lists ...
Objective: The purpose of this study was to compare the bioavailability between the two 30 mg tolvaptan tablets formulations and to evaluate the bioequivalence of Referen..
Patient weight is an essential parameter for medication safety and infection management. Drugs where body weight is important in the dose assessment are often prescribed without a recorded weight. Our study showed that large numbers of patients are not weighed on admission. The reasons for this omission are complex and may result in inaccurate dosing of certain narrow therapeutic index drugs, which could have serious consequences. From a medication safety perspective recording of patient weight is an essential step for the safe administration of many medicines with a narrow therapeutic index. In the case of antibiotics the need to keep drugs within the narrow therapeutic index during therapy, in addition to ensure efficacy and reduce toxicity is of significant importance for mitigating the emergence of resistance. If the antibiotic concentrations fall short of the minimum inhibitory concentrations there is a risk of resistance being developed to the antibiotic being used.6 ,7 Using the correct ...
WASHINGTON - The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.. The agency said that when it approved five generic versions of the antidepressant in the 300-mg strength, each of these generics was approved based on bioequivalence studies comparing the 150-mg strength of the products with Wellbutrin XL in the 150-mg strength. Studies, however, were not performed directly on the 300-mg strength of the products, but rather, bioequivalence studies were performed using the 150-mg strength and the results were extrapolated to establish bioequivalence of the 300-mg product, the agency said.. [The] FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300-mg bupropion hydrochloride extended-release tablets to Wellbutrin XL ...
Although FDA could have ended the Agencys analysis there, the Agency went on to address an argument from Sun that there was a change in ANDA bioequivalence requirements that caused the company to miss the 30-month tentative approval deadline. Specifically, Sun argued that after the submission of ANDA 078340, FDA required for the first time that the [bioequivalence] studies for [imatinib mesylate tablets] be performed on a patient population instead of a health volunteer population. FDA identified this as a bioequivalence deficiency in November 19, 2007 correspondence to Sun. Sun performed new studies and amended ANDA 078340 on April 2, 2009, and again on July 29, 2009. FDA reviewed Suns submissions and found bioequivalence to be acceptable on August 27, 2009, about two weeks prior to the September 12, 2009 30-month forfeiture event date. Suns bioequivalence data was determined to be acceptable prior to the 30-month forfeiture date; therefore, any changes in bioequivalence requirements ...
An outline of data updates to Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book, completed January 25, 2017. These updates will help applicants submitting an abbreviated new drug application (ANDA) to seek approval of a generic drug to identify the reference listed drug (RLD), reference standard, and basis of submission for an ANDA.
Forty-nine patients were randomised; 45 (92%) received all five treatments. Non-inferiority was demonstrated between the DPI and pMDI formulations at both doses (-0.2 bpm [95% CI -1.3, 0.9] for 200/12 μg and 0.6 bpm [-0.5, 1.7] for 800/48 μg). Although there were statistically significant treatment-placebo differences at both doses and with both devices (thus confirming assay sensitivity), these differences were small and well below 5 bpm for the 200/12 μg dose. The results for the secondary parameters (QTcF, glucose and potassium) further supported the therapeutic equivalence of the two treatments. At the therapeutic dose, there were no clinically relevant treatment-placebo differences in any parameter with either formulation. There was no increase in the proportion of patients reporting AEs whilst receiving therapeutic doses of BDF/FF (either formulation) compared with placebo.. CONCLUSIONS ...
a) A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall meet either one of the following requirements:. (1) Be an approved drug that is listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness.. (2) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Antiseptic Health-Care Drug Products as an antiseptic handwash.. (b) In addition to the requirements of subdivision (a), the hand antiseptic used as a topical application, hand antiseptic solution used as a hand dip, or hand antiseptic soap shall meet either one of the following requirements:. (1) Have components that are exempted from the requirement of being listed in federal Food Additive regulations as specified in 21 CFR 170.39- Threshold of regulation for substances used in food-contact articles.. (2) Comply with, and be listed in, either of the ...
For a generic medicine to be approved for therapeutic use, manufacturers must present clinical evidence to Medsafe to demonstrate that the medicine is bioequivalent to the originator brand of medicine or a suitable alternative, known as the reference medicine. Bioequivalence studies measure aspects of absorption and blood levels of the active ingredient including the area under the curve (AUC), which reflects the extent and duration of exposure to the active ingredient, and the maximum plasma concentration (Cmax).25 For each of these, if the 90% confidence interval for the ratio of the generic and reference medicines is within 80-125%, then the medicines are considered to be bioequivalent.25 The range of 80-125% for medicines to be accepted as bioequivalent is the international standard, used by Medsafe and international regulatory authorities such as the United States FDA, the European Medicines Agency and the Therapeutic Goods Administration of Australia.26, 27 This range accounts for ...
Aim: Determination of the bioequivalence of two metformin HCl (750 mg) caplet formulations (Glucophage XR® from Bristol-Myres Squibb Company, Indonesia as a reference..
To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
and expressly disclaims any duty to update information contained in this news release.. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar ...
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Following the previous release of top-line results, complete phase 3 data show that a biosimilar almost beat reference trastuzumab for the primary endpoint of pathologic complete response . Detailed... | octobre 5, 2017
Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured ...
This publication is printed on permanent, acid-free paper in compliance with G.S. 125-11.13 NORTH CAROLINA REGISTER VOLUME 21 ● ISSUE 13 ● Pages 1123 - 1245 JANUARY 2, 2007 I. EXECUTIVE ORDERS Executive Order No. 110.....................................................................................1123 Executive Order No. 111.....................................................................................1124 Executive Order No. 112.....................................................................................1125 Executive Order No. 113.....................................................................................1126 II. IN ADDITION Narrow Therapeutic Index Drugs........................................................................1127 Brownfields Property - Midtown Redevelopment Partners................................1128 Brownfields Property - South End Silos, LLC....................................................1129 III. PROPOSED RULES Environment and Natural ...
The search identified 121 potentially eligible studies that focused on ciprofloxacin. Initial screening of the abstracts clearly indicated that 113 of these
The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agencys expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs).
PUR0200 Trials for PK BE: Pulmatrix has completed two Phase 1 clinical trials of PUR0200 in support of PUR0200 bioequivalence to Spiriva HandiHaler. Bioequivalence is achieved when the plasma concentrations (Cmax and AUC0-t) of the drug after administration of the test formulation (PUR0200) are equivalent to the plasma concentrations after administration of the reference product (Spiriva HandiHaler). The completed clinical trials focused on identifying the necessary PUR0200 strength and aerosol properties to define a formulation that will achieve bioequivalence in a pivotal PK study. A two-part Phase 1b study was designed to determine the PK, PD and safety and tolerability of PUR0200 compared to Spiriva HandiHaler 18 μg in COPD patients. In the first part of the study, subjects were randomized to receive placebo or PUR0200 at one of 4 dose levels. The goal of the Part 1 study was to evaluate safety and tolerability of PUR0200 and compare the PK of PUR0200 to historical data to select dose ...
TY - JOUR. T1 - Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin (R). AU - Lambert, Peter A.. AU - Conway, Barbara R.. PY - 2003/8. Y1 - 2003/8. N2 - The pharmaceutical qualities of 34 ceftriaxone generic products were compared with Rocephin as the reference standard. Quality standards specified in the European and US Pharmacopoeias were violated on 18 occasions, including those for sterility (4 products) and impurities (5 products). All 34 generics tested failed to meet Roche specifications for Rocephin, with 100 contraventions of the Roche Pharmaceutical standards. The most common failures amongst generic drug products were clarity of solution (30 products) and presence of thiotriazinone (33 products).. AB - The pharmaceutical qualities of 34 ceftriaxone generic products were compared with Rocephin as the reference standard. Quality standards specified in the European and US Pharmacopoeias were violated on 18 occasions, including those for sterility (4 ...
The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers and to compare its rate and extent of absorption with the commercially available tablet Apo-Keto SR® as a reference product. The test formulation containing 20 % HPC (GXF) as release retardant was selected in this regards. The bioequivalence study was conducted according to a single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study design on six healthy non-smoking Malaysian adult male volunteers. Plasma concentrations of ketoprofen were determined by a high-performance liquid chromatographic method with UV detection. The pharmacokinetic parameters, Tmax , Cmax , AUC0-∞, Ke , and T1/2 were determined. The 90 % confidence intervals of the mean values for the test/reference ratios were 96.89-107.03 % for AUC0-∞ and 99.64-104.62 % for Cmax , respectively. The results of this study suggest that ...
Acrux is developing a range of topically applied products with an expanding pipeline of products under development. Topical products are applied to the skin as semi-solids (e.g. ointments, creams, gels, lotions, and suspensions) and also include products applied to the ear (otic), nose (nasal), eyes (ophthalmic) and rectum. Acrux uses its internal development capabilities and know-how to develop generics which target a substantial portion of the US topical market. The development time required for generic products is substantially shorter and less costly than the length of time required for a new drug development.. Generic pharmaceutical products are the pharmaceutical and therapeutic equivalents of the brand product. Accordingly, generic products provide a safe, effective and cost-efficient alternative to users of these reference brand.. Generic product development is generally less time-consuming and complex than the new chemical entity development process. It usually does not require new ...
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RICHARDS, G A et al. A comparison of the pharmacokinetics of Aspen Ceftriaxone and Rocephin in community-acquired meningitis. SAMJ, S. Afr. med. j. [online]. 2013, vol.103, n.12, pp.906-909. ISSN 2078-5135.. BACKGROUND: Community-acquired bacterial meningitis (CABM) is a life-threatening condition that is common among immunocompromised individuals. Intravenous ceftriaxone, of which Rocephin (ROC) is the originator brand, is recommended as first-line therapy in South Africa. Despite concerns regarding therapeutic equivalence with generic agents, this is the first study that has been conducted comparing clinical pharmacokinetics (PK) of a generic ceftriaxone formulation with the originator. OBJECTIVE: To compare the PK and safety of Aspen Ceftriaxone (AC) and ROC in the treatment of adult CABM. METHODS: A total of 63 eligible patients were randomised 1:1 to receive 2 g of either medication twice daily for a duration based on the identity of the causative organism and their physicians clinical ...
Paroxetine. a potent and selective serotonine reuptake inhibitor. has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchullv Paroxetine tablet`` made by Samchullv Pharm. Co. and the reference product was Seroxat tablet made by GlaxoSmithKline. Twenty healthy male subjects. 22.4±2.6 years old and 63.8±4.2 kg. were divided into two groups and a randomized 2x2 cross-over study was employed. After one tablet containing 20 mg paroletine was orally administered. blood was taken at predetermined time intervals and the concentration of paroletine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters. AUCr and Cma.. were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of ...
Clinical trial for Hypertension During Pre-Eclampsia , Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
Ingelheim/Germany and Madrid/Spain, June 14, 2017 - Boehringer Ingelheim announced today results from the pivotal Phase III VOLTAIRE®-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.. These data confirm the clinical efficacy equivalence of BI 695501 to HUMIRA®. The safety and immunogenicity data in the study were also similar between BI 695501 and HUMIRA®.. In the VOLTAIRE®-RA1 study 645 patients aged between 18 and 80 years old with moderate-to-severely active rheumatoid arthritis on stable treatment with methotrexate were randomised to receive HUMIRA® or BI 695501 at 40 mg every two weeks for 48 weeks. The co-primary endpoints, which measured the proportion of patients achieving an ACR20** (American College of Rheumatology 20) ...
ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.
Once the similarity with the reference product has been established in terms of structure, function, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity, the biosimilar is acknowledged as similar to the reference product. In the event that the reference product is licensed for multiple therapeutic indications, extrapolation of indications may be possible with scientific justification. Extrapolation is defined as the approval of a biosimilar for use in an indication held by the reference product that has not been directly studied in a comparative clinical trial with the biosimilar.11 Regulatory agencies such as the EMA, FDA, and WHO require comprehensive comparability that focuses on efficacy, safety, and immunogenicity with a clinically relevant mechanism of action and receptors in the indication for an extrapolation to be considered.4-6 Additional information may be required if the mechanism of action or receptors involved are different in order to justify the extrapolation ...
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The national debate over the rising cost of prescription medicines drew attention to the huge backlog of generic drug applications at the US Food and Drug Administration (FDA).[50]. Usually, when enough generic drug products are introduced to the market, the cost to buy prescription medications decreases for both the insurer and the patient.[51][52] Generic drugs have been shown to reduce healthcare costs in multiple ways, among them increasing competition which, in most cases, helps drive prices down.[53] https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm129445.gif Companies that want to manufacture generic drugs must show in their applications to the FDA that they guarantee quality and bioequivalence. In July 2016, the FDA generic drug application backlog comprised 4,036 generics. On the other hand, the European Medicine Agency (EMA), Europes equivalent to the FDA, had only 24 generics drug applications awaiting approval. This count includes biologically based biosimilars ...
Under Hatch-Waxman, drug companies may file a so-called abbreviated new drug application (ANDA) with the FDA to seek approval for generic versions of already-approved drugs by submitting bioequivalence studies instead of clinical studies, which is a much cheaper method than the normal FDA process. Branded companies that own the patents and believe the generic will infringe must then sue to enforce their patent rights to attempt to prevent the approval of the infringing generic.. As part of the ruling, the court permanently enjoined the defendants from the commercial manufacture, use, offer to sell and/or sale of their proposed generic products in, as well as the import of those products into, the U.S. or its territories.. We are very pleased for our client Allergan and to have had the privilege of representing them in this case, said Jonathan Singer, head of the Life Sciences Litigation practice at Fish & Richardson who, along with Juanita Brooks and Douglas McCann, led the litigation and ...
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Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandozs Zarxio, a biosimilar of Amgens Neupogen, was the first biosimilar to be approved. Zarxio, a relatively simple biologic, was approved in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Zarxio has now has been on the market for a year (since September 2015). This year, FDA approved two complex biologics, Celltrion and Pfizers Inflectra, a biosimilar of Janssens Remicade, and Sandozs Erelzi, a biosimilar of Amgens Enbrel. FDA staff and its arthritis advisory committee also recommended approval of Amgens ABP 501, a proposed biosimilar of AbbVies Humira. On the other hand, Sandozs revealed in July that its biosimilar application for Amgens Neulasta, a long-acting version of Neupogen, had been rejected by FDA and Hospira did the same last year for its application for Amgens EPO. Although the approvals (and rejections) provide ...
Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandozs Zarxio, a biosimilar of Amgens Neupogen, was the first biosimilar to be approved. Zarxio, a relatively simple biologic, was approved in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Zarxio has now has been on the market for a year (since September 2015). This year, FDA approved two complex biologics, Celltrion and Pfizers Inflectra, a biosimilar of Janssens Remicade, and Sandozs Erelzi, a biosimilar of Amgens Enbrel. FDA staff and its arthritis advisory committee also recommended approval of Amgens ABP 501, a proposed biosimilar of AbbVies Humira. On the other hand, Sandozs revealed in July that its biosimilar application for Amgens Neulasta, a long-acting version of Neupogen, had been rejected by FDA and Hospira did the same last year for its application for Amgens EPO. Although the approvals (and rejections) provide ...
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respectively. The MAA for F/TAF is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The MAA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF. Review of the MAA will be conducted by the EMA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the ...
Residents are able to earn a high school or high school equivalency diploma. In the late 2010s, the Commonwealth of Virginia ... Specialized treatment programs include substance abuse, aggression management, sex offender, and intensive therapeutic ...
It has major active benzodiazepine metabolites, which gives it a more prolonged therapeutic effects after administration. ... Ashton H (April 2007). "Benzodiazepine Equivalency Table". Benzodiazepines Co-operation Not Confrontation (BCNC). Retrieved ...
... therapeutic equivalency MeSH G12.091.690.949 - tissue distribution MeSH G12.361.310 - drug antagonism MeSH G12.361.477 - drug ...
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The model is educational rather than therapeutic, and functions as an extended family rather than a program. The central "each- ... residents earn a high school equivalency degree (GED), and then may pursue higher education, including through an in-house ...
He then moved to Munich for several years, where he gained his Veterinary Medicine Equivalency from LMU, worked there as a Post ... and served as a scientific adviser to Therapeutic Human Polyclonals in Tucson, USA and Agrobiogen GmbH in Laretzhausen, Germany ...
Briones, Elizabeth M.; Benham, Grant (2016-02-23). "An examination of the equivalency of self-report measures obtained from ... Neurological examination in neurology Mental state examination in psychiatry Physical examination in medicine Therapeutic ...
... isomer has no therapeutic effect, as well as being highly toxic. In some cases, the less therapeutically active enantiomer can ... and SSR with progressively decreasing biological equivalency, so that 1.36 mg of dl-tocopherol is considered equivalent to 1.0 ...
2 mg of oxazepam equates to 1 mg of diazepam according to the benzodiazepine equivalency converter, therefore 20 mg of oxazepam ... it was determined that there would be no therapeutic benefit to the administration of a single enantiomer over the racemic ... Some BZD equivalency converters use 3 to 1 (oxazepam to diazepam), 1 to 3 (diazepam to oxazepam) as the ratio (3:1 and 1:3), so ... according to BZD equivalency equates to 10 mg of diazepam and 15 mg oxazepam to 7.5 mg diazepam (rounded up to 8 mg of diazepam ...
The therapeutic potential of adult stem cells is the focus of much scientific research, due to their ability to be harvested ... Multipotent stem cells with a claimed equivalency to embryonic stem cells have been derived from spermatogonial progenitor ... Olfactory stem cells hold the potential for therapeutic applications and, in contrast to neural stem cells, can be harvested ... There is yet no consensus among biologists on the prevalence and physiological and therapeutic relevance of stem cell ...
There is an overall absence of sound statistical evidence of therapeutic efficacy, which is consistent with the lack of any ... "Bangladesh Homoeopathy Board - Bangladesh Homoeopathy Board". Raghu Korrapati, Dr (July 6, 2017). Educational Equivalency ... In the 21st century a series of meta-analyses have shown that the therapeutic claims of homeopathy lack scientific ... In Australia, the sale of homeopathic products is regulated by the Therapeutic Goods Administration. In 2015, the National ...
Therapeutic assessment. Notes and references[edit]. *^ Framingham, J. (2011). What is Psychological Assessment?. Psych Central ... "An examination of the equivalency of self-report measures obtained from crowdsourced versus undergraduate student samples" ...
This course is an elective through a life changing program called Therapeutic Community at Westville Correctional Facility. "TC ... General Equivalency Diploma program and literacy program. As recently as 2004, Westville faced two legal battles, both ... Dave Ramsey's nationally known program, Financial Peace University is now being taught within the Therapeutic Community. FPU is ...
The American Therapeutic Recreation Association (ATRA) and the Canadian Therapeutic Recreation Association (CTRA) are the ... There is also an Equivalency Path A and B for certification. The requirements are slightly different and include a bachelor's ... Therapeutic Recreation Directory O*Net Online Summary Report for Recreational Therapists American Therapeutic Recreation ... "CTRA - Canadian Therapeutic Recreation Association - Uniting Therapeutic Recreation Across Canada". "NCTRC". "CTRS Specialty ...
In wild type PP2A, the inhibitory equivalency relative to okadaic acid were 0.9 for DTX-1 and 0.6 for DTX-2. The main route of ... A Novel Tool for Alzheimer's Disease Therapeutic Application". Mol. Neurobiol. 50 (3): 852-865. doi:10.1007/s12035-014-8699-4. ... Garibo, D.; de la Iglesia, P.; Diogène, J; Campàs, M. (2013). "Inhibition Equivalency Factors for Dinophysistoxin-1 and ... inhibitory equivalency factors for the relatives of okadaic acid have been studied. ...
... therapeutic singing, therapeutic instrumental music playing, music-facilitated reminiscence and life review, songwriting, music ... Many AMTA approved programs offer equivalency and certificate degrees in music therapy for students that have completed a ... Standley JM, Moore RS (1995). "Therapeutic effects of music and mother's voice on premature infants". Pediatric Nursing. 21 (6 ... The strong emphasis on social integration and the involvement of parents in the therapeutic process found in social pediatrics ...
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Because dioxins refer to such a broad class of compounds that vary widely in toxicity, the concept of toxic equivalency factor ... from mediator of dioxin toxicity to physiologic AHR functions and therapeutic options." Biological chemistry 398 (4): 455-464. ... Tuomisto, Jouko (2011). "The Toxic Equivalency Principle and its Application in Dioxin Risk Assessment". The AH Receptor in ... October 2006). "The 2005 World Health Organization reevaluation of human and Mammalian toxic equivalency factors for dioxins ...
He founded osteopathic medicine in rural Missouri at a time when medications, surgery, and other traditional therapeutic ... by the US federal government was a key goal of the osteopathic medical profession in its effort to establish equivalency with ...
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"Benzodiazepine Equivalency Table: Benzodiazepine Equivalency". 28 April 2017. Retrieved 19 February 2018. Lander CM; Eadie MJ; ... 2007). Therapeutic uses of botulinum toxin. Totowa, N.J.: Humana Press. p. 214. ISBN 9781597452472. Archived from the original ... "Benzodiazepine Equivalency Table" based on NRHA Drug Newsletter, April 1985 and Benzodiazepines: How they Work & How to ... Cooper, Grant (2007-10-05). Therapeutic Uses of Botulinum Toxin. ISBN 9781597452472. "Drug Abuse Warning Network, 2006: ...
Similarly, there is equivalency between an overly stingy assessment and an overly generous assessment. D. Menashe The Logic of ... He is also a member of the International Society for Therapeutic Jurisprudence. His field of expertise is Theory of Evidence ... Menashe is also a member of the International Society for Therapeutic Jurisprudence. As a youth, Menashe played football ...
However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ... Office of the Gene Technology Regulator (overseas all), Therapeutic Goods Administration (GM medicines) and Food Standards ... This can be for therapeutic use, for example, treatment of diseases in other mammals. ... while regulation is provided by the Therapeutic Goods Administration for GM medicines or Food Standards Australia New Zealand ...
April 2007). "Benzodiazepine equivalency table". Retrieved September 23, 2007. Vozeh S (November 1981). "[Pharmacokinetic of ... Three years later chlordiazepoxide was marketed as a therapeutic benzodiazepine medication under the brand name Librium. ...
Concern has arisen in recent years over increasing rates of resistance to carbapenems, as there are few therapeutic options for ... Meropenem: Equivalency of Clinical and Microbiological Outcomes. 2010. ... Slama TG (2008). "Clinical review: balancing the therapeutic, safety, and economic issues underlying effective antipseudomonal ...
Hence antagonists of this receptor are entry inhibitors and have potential therapeutic applications in the treatment of HIV ... The temporal equivalency of the murine 6 weeks study may be up to 6 years in humans. In May 2019, the U.S. Food and Drug ...
Therapeutic Guidelines: Analgesic. Version 4. Melbourne: Therapeutic Guidelines Ltd, 2007. "Oxycodone". www.drugbank.ca. ... 491-. ISBN 978-0-7295-8081-6. "Stanford School of Medicine, Palliative Care, Opioid Conversion / Equivalency Table". 2013-04-20 ... Therapeutic Goods Administration (June 2008). Standard for the uniform scheduling of drugs and poisons no. 23 (PDF). Canberra: ...
The nutritional content of vitamin E is defined by equivalency to 100% RRR-configuration α-tocopherol activity. The molecules ... but no certain therapeutic use and no definite deficiency disease in man." The animal discovery experiments had been a ... SRR and SSR with progressively decreasing biological equivalency, so that 1.36 mg of dl-tocopherol is considered equivalent to ...
... courses can range from basic literacy courses and secondary school equivalency programs to vocational ... Prison education also has therapeutic benefits such as alleviating boredom, improving self-esteem and stimulating creativity, ... Courses can include basic literacy programs, secondary school equivalency programs, vocational education and tertiary education ...
However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ... Therapeutic cloning. *Embryology. *Environmental biotechnology. *Genetic engineering *Genetically modified organism. *Molecular ...
Therapeutic uses of technology such as cochlear implants, prosthetic limbs, and psychotropic drugs have become commonly ... as in striving towards ontological equivalency. ... technologies using the distinction between therapeutic and ...
The therapeutic potential of adult stem cells is the focus of much scientific research, due to their ability to be harvested ... Multipotent stem cells with a claimed equivalency to embryonic stem cells have been derived from spermatogonial progenitor ... Olfactory stem cells hold the potential for therapeutic applications and, in contrast to neural stem cells, can be harvested ... There is yet no consensus among biologists on the prevalence and physiological and therapeutic relevance of stem cell ...
Office of the Gene Technology Regulator (oversees all GM products), Therapeutic Goods Administration (GM medicines) and Food ... However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ...
However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ... Tobacco plants have been modified to produce therapeutic antibodies.[147] ... However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ...
"Benzodiazepine Equivalency Table: Benzodiazepine Equivalency". 28 April 2017. Retrieved 19 February 2018.. ... Cooper, edited by Grant (2007). Therapeutic uses of botulinum toxin. Totowa, N.J.: Humana Press. p. 214. ISBN 9781597452472. . ... "Benzodiazepine Equivalency Table" based on NRHA Drug Newsletter, April 1985 and Benzodiazepines: How they Work & How to ... Cooper, Grant (2007-10-05). Therapeutic Uses of Botulinum Toxin. ISBN 9781597452472. .. ...
For many years, a system of equivalencies in which an international unit (IU) was equal to 0.3 μg of retinol, 0.6 μg of β- ... Vivat-Hannah V, Zusi FC (2005). "Retinoids as therapeutic agents: today and tomorrow". Mini Reviews in Medicinal Chemistry. 5 ( ... Equivalencies of retinoids and carotenoids (IU). As some carotenoids can be converted into vitamin A, attempts have been made ...
"Therapeutic Advances in Psychopharmacology. 5 (3): 179-88. doi:10.1177/2045125315583786. PMC 4502590. PMID 26199721.. ... akin to those available to the Commission for tackling the manifold issues involved with determining a proper drug equivalency ... "Therapeutic Drug Monitoring. 30 (3): 320-32. doi:10.1097/FTD.0b013e3181684fa0. PMC 2663855. PMID 18520604.. ... Therapeutic Drug Monitoring. 26 (2): 137-44. doi:10.1097/00007691-200404000-00009. PMID 15228154. It is known that some ...
Gasdaska JR et al. (2003) "Advantages of Therapeutic Protein Production in the Aquatic Plant Lemna". BioProcessing Journal Mar/ ... However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ... Walsh, Gary (April 2005). "Therapeutic insulins and their large-scale manufacture". Appl. Microbiol. Biotechnol. 67 (2): 151- ... to produce products intended for human therapeutic use (pharmaceutical products or tissue for implantation); ...
Byrd got her graduate equivalency diploma and then pursued advertising design at Baruch College but dropped out in her senior ... best known for his theory of human motivation which led to a therapeutic technique known as self-actualization, Brooklyn ...
However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied ... Tobacco plants have been modified to produce therapeutic antibodies. Algae is under development for use in biofuels. ...
The species chosen will usually meet a determined taxonomic equivalency[clarification needed] to humans, so as to react to ... "Therapeutic modulation of eIF2α-phosphorylation rescues TDP-43 toxicity in amyotrophic lateral sclerosis disease models". ...
For many years, a system of equivalencies in which an international unit (IU) was equal to 0.3 μg of retinol (~1 nmol), 0.6 μg ... American Cancer Society: Retinoid Therapy Vivat-Hannah V, Zusi FC (August 2005). "Retinoids as therapeutic agents: today and ...
Therapeutic Equivalency. Additional relevant MeSH terms: Lovastatin. L 647318. Dihydromevinolin. Anticholesteremic Agents. ...
Therapeutic Equivalency Drug: Primidone 50 mg Tablet Drug: Primidone (Mysoline®) 50 mg Tablet Phase 1 ...
Equivalence trials aim to show that two treatments have equivalent therapeutic effects. The approach is to define, in advance, ... Equivalence trials aim to show that two treatments have equivalent therapeutic effects. The approach is to define, in advance, ... The relative importance of the two analyses will depend on the definitions used in particular therapeutic areas. Demonstrating ...
Therapeutic Equivalency * Visual Acuity / drug effects Substances * Antibodies, Monoclonal * Antibodies, Monoclonal, Humanized ...
Military equivalency.. HTMLPDF. 246-926-150. Certification designation for diagnostic, therapeutic, or nuclear medicine ... Therapeutic radiologic technologist-Alternative training.. HTMLPDF. 246-926-130. Nuclear medicine technologist-Alternative ... Approved schools for diagnostic, therapeutic, or nuclear medicine radiologic technologists.. HTMLPDF. 246-926-145. ... Radiologist assistants; diagnostic, therapeutic, and nuclear medicine radiologic technologists; cardiovascular invasive ...
Therapeutic Equivalency. The relative equivalency in the efficacy of different modes of treatment of a disease, most often used ...
Therapeutic Equivalency. Chemical. Reg. No./Substance: 0/Biopolymers; 0/Delayed-Action Preparations; 0/Solvents ...
Therapeutic equivalency of low-molecular-weight heparins. Ann Pharmacother 2002;36:1042-1057. ... In this regard, it is worth noting that modern therapeutic approaches have tended to become more and more specific, being ... implications for the use of unfractionated and low molecular weight heparins as therapeutic agents. J Clin Invest 1998;101:877- ... a possible mechanism for difference in therapeutic efficacy. Thromb Res 1998;91:177-181. ...
... promoting equivalency in people; and not presupposing what people will be like, do, or become, during or after the therapeutic ... and congruence in the therapeutic situation. Just being able to maintain openness, honesty, empathy, and respect toward a ... on the harmonious relationship between counselor and client should be appreciated as a significant insight into the therapeutic ...
Therapeutic interventions after spinal cord injury. Nat Rev Neurosci. 2006;7(8):628-643.. View this article via: PubMed Google ... Nevertheless, their biological equivalency/heterogeneity and identity are largely unknown (31). Tooth-derived stem cells ... Therapeutic applications of oligodendrocyte precursors derived from human embryonic stem cells. Curr Opin Biotechnol. 2007;18(5 ... Thus, the anti-AGI activity of tooth-derived stem cells is one of their major therapeutic benefits for the treatment of SCI. ...
HERRERA-CALDERON, Oscar y GRANDE-ORTIZ, Miguel. Therapeutic equivalency of tablets of diazepam dispended in the city of Ica, ... To establish therapeutic equivalence, we used the similarity factor (f2) and considered therapeutic equivalence if values were ... Objectives: To determine the in-vitro therapeutic equivalence of three formulations of diazepam in tablets of 10mg to establish ...
The general concensus on therapeutic doseage equivalency among benzodiazepines is as follows: .5mg xanax 1 mg Ativan .5 mg ... Dependence ensues quickly even at therapeutic doses , resulting in what is considered to be one of the worst withdrawal ...
155 Therapeutic class Code indicating the products therapeutic class characteristics. 156 Therapeutic equivalency Code ... indicating the products therapeutic equivalency characteristics. 157 Filter Code indicating the products filter ...
... equivalency of continuous veno-veno hemofiltration or intermittent hemodialysis (2B); prophylaxis for deep vein thrombosis (1A ... Recommendations specific to pediatric severe sepsis include greater use of physical examination therapeutic end points (2C); ... equivalency of continuous veno-veno hemofiltration or intermittent hemodialysis (2B); prophylaxis for deep vein thrombosis (1A ... Recommendations specific to pediatric severe sepsis include greater use of physical examination therapeutic end points (2C); ...
It has major active benzodiazepine metabolites, which gives it a more prolonged therapeutic effects after administration. ... Ashton H (April 2007). "Benzodiazepine Equivalency Table". Benzodiazepines Co-operation Not Confrontation (BCNC). Retrieved ...
Once all the equivalency tests have been conducted, the generic drug is considered a therapeutic equivalent. This means that ...
Residents are able to earn a high school or high school equivalency diploma. In the late 2010s, the Commonwealth of Virginia ... Specialized treatment programs include substance abuse, aggression management, sex offender, and intensive therapeutic ...
Negative results of randomized clinical trials published in the surgical literature: equivalency or error? ... In this article, we use the U.S. Food and Drug Administration (FDA) definition of a therapeutic device (2) as "an instrument, ... Therapeutic devices and surgical procedures obviously vary greatly in complexity and costs; however, the issues we discuss here ... Therapeutic devices and surgical procedures are often evaluated in nonrandomized studies or small single-center trials. While ...
Few methadone patients apply to therapeutic communities, and few therapeutic communities will accept them. Methadone patients ... may anticipate that therapeutic communities will be inhospitable because many therapeutic communities traditionally have held ... Methadone maintenance and therapeutic communities are two effective treatment approaches that are seldom combined. ... Methadone patients in the therapeutic community: A test of equivalency. Drug and Alcohol Dependence 100(1-2):100-106, 2009. [ ...
What therapeutic equivalency code means they are considered therapeutically equivalent to other drugs? ... What therapeutic equivalent code means these drugs have actual or potential bio equivalence problems that have it been resolved ... What type of therapeutic classification indicates that the drug is similar to other drugs in the market? ... If a drug has the same therapeutic moiety but with different salts esters or complexes or have different dosage forms or ...
Random allocation, fexofenadine, montelukast, therapeutic equivalency, liquid chromatography. Allergic rhinitis is a global ...
These results suggest that many people who receive strong opioids may be unable to achieve the optimal therapeutic dose due to ... "We observed a relevant relationship between morphine dose equivalency and the magnitude of pain relief at the final follow-up. ... One possible reason is that many participants who received strong opioids were unable to achieve the optimal therapeutic dose ... Meta-regression was performed to assess the impact of dosage (morphine equivalency) on pain relief. ...
If therapeutic and reproductive cloning are the same thing, then why has Congress been considering two rival bills, one to ban ... So now human cloning is on a par with 9/11? Talk about moral equivalency. ... And of course, he doesnt mention the fact that the purpose of therapeutic cloning is to help scientists cure disease and save ... "Knowing how to clone a human embryo for "therapeutic" purposes...doesnt mean, in the technical sense, that were ready to ...
ACP does recommend physicians prescribe generics when therapeutic equivalency and safety are established -- although it does ... "You might have an increase in side effects with the change, or you might feel youve lost a bit of the therapeutic effect." ... Many physicians have found that these switches are particularly problematic in classes of drugs with a narrow therapeutic range ... Yet reports of problems when switching from brand name to generic, particularly for narrow therapeutic index drugs like ...
Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency ...
International equivalencies About this degree. The programme draws together theory, research and therapeutic thinking from a ... Since the MSc was established in 2011 graduates have gone on to work with children and families in various therapeutic settings ... and practical skills necessary for therapeutic work with children and families. These are then put into practice during the ... such as the evaluation and understanding of clinical and therapeutic services for children and young people. This culminates in ...
... as a screening tools for detecting cognitive decline or alterations in an effort to allow physician directed therapeutic ... The Equivalencies Test INH-REST is based on Stroops classic test. This test evaluates the users capacity to discern between ...
Mystics have sometimes elaborated "equivalencies," analogizing the waxing and waning of the moon with influences on human ... Bloodletting refers to the removal of blood from a vein usually for therapeutic measures. ...
During this reporting period (36 month), we have tested the equivalency of these lots and confirmed that lots manufactured at ... The overall goal of this proposal is to develop a hESC-based therapeutic candidate (dopaminergic neurons) by developing ... In this application we and our collaborators in California aim propose to develop a hESC-based therapeutic candidate ( ... Importantly, we have shown functional equivalency of the manufactured cells in appropriate models. The tools, reagents and ...
Applicants with GED® credentials should have a transcript of equivalency scores sent to CCRI from the General Equivalency ... Therapeutic Massage. CCRI has instituted a performance-based application process for selected Health Sciences programs. Please ... Equivalencies from correspondence schools are not acceptable. Home-school transcripts must be official, and documentation from ... An evaluation by an accrediting agency certifying that secondary school transcripts indicate equivalency to U.S. secondary ...
  • The authors discuss 3 challenges in conducting and interpreting any systematic review that are particularly relevant for systematic reviews of therapeutic devices or surgical procedures: 1) inclusion or exclusion of grey literature, 2) the role of nonrandomized studies, and 3) issues in applying the results to clinical care that are unique to the surgical and therapeutic device literature. (annals.org)
  • The programme draws together theory, research and therapeutic thinking from a range of perspectives, including clinical and cognitive psychology, systemic thinking, psychoanalysis and neuroscience. (ucl.ac.uk)
  • All MSc students undertake a research portfolio which may include both a developmental and a clinical focus, such as the evaluation and understanding of clinical and therapeutic services for children and young people. (ucl.ac.uk)
  • Develop a scalable GMP compatible process for production of clinical grade dopaminergic neurons from hESCs and/(or) hiPSCs to support the development of a therapeutic cell candidate for Parkinson's disease (PD), and generate sufficient supporting data from scalable culture to make a case to move to pre-clinical development work. (ca.gov)
  • The overall goal of this proposal is to develop a hESC-based therapeutic candidate (dopaminergic neurons) by developing enabling reagents/tools/processes that will allow us to translate our efforts into clinical use. (ca.gov)
  • Antibody-dependent cellular cytotoxicity (ADCC) has recently been identified as one of the critical mechanisms underlying the clinical efficacy of therapeutic antibodies, especially anticancer antibodies. (biomedcentral.com)
  • Hence, ADCC enhancement technology is expected to play a key role in the development of therapeutic antibodies with improved clinical efficacy. (biomedcentral.com)
  • Clinical equivalency and bioavailability of sodium warfarin from multiple sources. (ucsd.edu)
  • In this clinical equivalency trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups. (bioportfolio.com)
  • The timely FebriDx test results provide clinicians the ability to formulate a targeted clinical management and therapeutic decision plan during the initial patient encounter. (medindia.net)
  • Therapeutic Interchange Tool:Computing dose equivalencies and comparisons for various medications based on clinical studies and pharmaceutical monographs.This includes ACE inhibitors dosage conversion, Angiotensin Receptor Blockers (ARBs) dosage conversion, IV to PO dosage conversion, Beta-blockers dosage conversion, statins (HMG-CoA Reductase Inhibitors) dosage conversion, diuretics conversion, anti-diabetic medications dosage conversion, Proton Pump Inhibitors (PPIs) dosage conversion and many more.7. (zdnet.com)
  • Children and adolescents who participated in the PCOMS therapeutic sessions realized clinically superior outcomes in comparison to a wait list benchmark drawn from youth depression clinical trials. (bio-medicine.org)
  • Our findings of large effect sizes and overall clinical equivalency with RCT treatment outcomes support the contention that psychotherapy that includes systematic client feedback may be an effective quality improvement strategy in services with youth in public behavioral health. (bio-medicine.org)
  • To determine the in-vitro therapeutic equivalence of three formulations of diazepam in tablets of 10mg to establish their interchangeability with the original brand name product. (scielo.org.pe)
  • As molecular-targeted therapeutics, therapeutic antibodies that bind to specific cell-surface antigens on target cells can induce cytotoxicity via the effector functions of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through the constant region of the antibody (Fc), and apoptosis of target cells directly [ 6 - 9 ]. (biomedcentral.com)
  • Research has established that most patients require a methadone dose of 60-120 mg/day, depending on their individual responses, to achieve optimum therapeutic effects. (drugabuse.gov)
  • Though results of meta-regression exploring dose effects revealed a relevant relationship between opioid dosage, or morphine equivalency, and the magnitude of pain relief, participants receiving strong opioids were nearly twice as likely to discontinue due to adverse events than those receiving weak/intermediate opioids. (eurekalert.org)
  • One possible reason is that many participants who received strong opioids were unable to achieve the optimal therapeutic dose as a result of attrition related to a lack of tolerability. (eurekalert.org)
  • We observed a relevant relationship between morphine dose equivalency and the magnitude of pain relief at the final follow-up. (eurekalert.org)
  • These results suggest that many people who receive strong opioids may be unable to achieve the optimal therapeutic dose due to a lack of tolerability. (eurekalert.org)
  • IVtoGo is a tasty, portable, drinkable version of a therapeutic high-dose Vitamin C IV treatment. (essense-of-life.com)
  • Liposomes are natural nano-sized packages used to deliver supplements and other therapeutic substances straight to cells, with minimal loss in metabolism. (essense-of-life.com)
  • Each bottle contains 3 courses of IV-equivalent therapeutic dosage with the bio-equivalency of 25 grams of IV Vitamin C. Smaller doses can be taken for health maintenance. (essense-of-life.com)
  • We highlight 3 challenges that may arise in conducting and interpreting any systematic review that evaluates the efficacy or effectiveness of therapeutic devices or surgery. (annals.org)
  • This term means that our essential oils will always maintain the highest quality standard in therapeutic grade essential oils for purity and efficacy. (lazymanandmoney.com)
  • The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. (bvsalud.org)
  • Equivalence trials aim to show that two treatments have equivalent therapeutic effects. (nih.gov)
  • To establish therapeutic equivalence, we used the similarity factor (f2) and considered therapeutic equivalence if values were between 50 and 100. (scielo.org.pe)
  • The place of therapeutic corticosteroids in critically ill patients with sepsis is controversial. (biomedcentral.com)
  • However, not all therapeutic corticosteroids are the same. (biomedcentral.com)
  • Once all the equivalency tests have been conducted, the generic drug is considered a therapeutic equivalent. (scientificamerican.com)
  • FDA assigns an equivalency rating to human generic drugs, which states whether the generics are therapeutically equivalent (achieve the same therapeutic goal) as compared to the branded product. (avma.org)
  • however, new therapeutic interventions comprising the entire immunosuppressive armamentarium including biologics as well as cellular-based therapies have been proposed [ 7 ]. (hindawi.com)
  • The current state of data suggests equivalency in most procedures with regard to traditional outcome measures, equal or somewhat elevated costs, with specific areas of superiority. (springer.com)
  • University of Roehampton Professor Dr. Mick Cooper said, "There's strong evidence over the last twenty years that the Partners for Change Outcome Management System improves therapeutic results with adults. (bio-medicine.org)
  • Using a human ex vivo B-cell depletion assay with non-fucosylated and fucosylated anti-CD20 IgG1s rituximab, we monitored the binding of the therapeutic agents both to antigens on target cells (target side interaction) and to leukocyte receptors (FcγR) on effector cells (effector side interaction), comparing the intensities of ADCC in human blood. (biomedcentral.com)
  • Dependence ensues quickly even at therapeutic doses , resulting in what is considered to be one of the worst withdrawal syndromes by the medical community when abruptly discontinued. (urbandictionary.com)
  • We performed a network meta-analysis (NMA) on the data used for the Cochrane review to establish the likely effectiveness of each drug and therapeutic regimen in adults with septic shock. (biomedcentral.com)
  • Through comprehensive analytical testing as well as a multicenter precision and reproducibility study, RPS Diagnostics successfully demonstrated equivalency to the previously CE marked version of the product. (medindia.net)
  • Therapeutic devices and surgical procedures are often evaluated in nonrandomized studies or small single-center trials. (annals.org)
  • Methadone patients may anticipate that therapeutic communities will be inhospitable because many therapeutic communities traditionally have held that recovery requires abstinence from all psychoactive drugs, including medications. (drugabuse.gov)
  • Approved schools for diagnostic, therapeutic, or nuclear medicine radiologic technologists. (wa.gov)
  • State examination/examination waiver/examination application deadline for diagnostic, therapeutic, or nuclear medicine radiologic technologists. (wa.gov)
  • In a workshop setting, students develop competencies in engagement, assessment and evaluation, and practical skills necessary for therapeutic work with children and families. (ucl.ac.uk)
  • A proven therapy method for adults called 'systematic feedback', in which client feedback is provided to the counselor at each therapeutic session, has shown indications of benefit in two new studies with children and adolescents. (bio-medicine.org)
  • Few methadone patients apply to therapeutic communities, and few therapeutic communities will accept them. (drugabuse.gov)
  • Opioid-dependent patients who were taking methadone upon admission to a therapeutic community fared as well as the rest of the community over 2 years of followup. (drugabuse.gov)
  • The researchers recruited 145 men and 86 women at the time of their admission to Walden House, a San Francisco therapeutic community that has been accommodating methadone patients for over 2 decades. (drugabuse.gov)
  • The methadone patients were similar to the others in terms of co-occurring stimulant abuse, psychiatric history, criminal justice involvement, and expected length of stay in the therapeutic community. (drugabuse.gov)
  • Music therapists are uniquely trained to harness the therapeutic qualities of music to use with even the most fragile children, including surgical patients and babies in the neonatal intensive care unit (NICU) . (luriechildrens.org)
  • Care provided patients requiring extraordinary therapeutic measures in order to sustain and prolong life. (bioportfolio.com)
  • It has major active benzodiazepine metabolites, which gives it a more prolonged therapeutic effects after administration. (wikipedia.org)
  • Being able to measure easily the effects of therapeutic experiences can validate the benefits of intervention. (researchgate.net)
  • The precise mechanisms responsible for the high ADCC mediated by fully non-fucosylated therapeutic antibodies, even in the presence of human plasma, should be explained based on direct evidence of non-fucosylated antibody action in human blood. (biomedcentral.com)
  • CogniFit assessments are intended as a screening tools for detecting cognitive decline or alterations in an effort to allow physician directed therapeutic intervention to occur. (cognifit.com)
  • Methadone maintenance and therapeutic communities are two effective treatment approaches that are seldom combined. (drugabuse.gov)
  • The control treatment was non-therapeutic social interaction. (researchgate.net)
  • In particular, plug therapeutic medical appliances are provided that allow for the interventional treatment of pulmonary disorders such as defects characterized by pulmonary blebs and/or diffused destructive parenchymal disease. (google.com)
  • Amino-acid-enriched cereals ready-to-use therapeutic foods (RUTF) are as effective as milk-based RUTF in recovering essential amino acid during the treatment of severe acute malnutrition in children: An individually randomized control trial in Malawi. (bioportfolio.com)
  • Integral to the rise of minimal access and therapeutic techniques in surgery has been the growth of technological improvements over time. (springer.com)
  • The authors also discus s empirical evidence related to these topics and illustrate how reviewers in the Agency for Healthcare Research and Quality's Evidence-based Practice Center program have dealt with these challenges in developing evidence reports for decision makers and clinicians about therapeutic devices or surgical procedures. (annals.org)
  • Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. (drugs.com)
  • If therapeutic and reproductive cloning are the same thing, then why has Congress been considering two rival bills, one to ban all human cloning and one that allows therapeutic cloning? (prospect.org)
  • Knowing how to clone a human embryo for "therapeutic" purposes. (prospect.org)
  • Many physicians have found that these switches are particularly problematic in classes of drugs with a narrow therapeutic range, including antiepileptics, psychotropics, antiarrhythmics, and anticoagulants. (medpagetoday.com)
  • Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs, such as antibiotics. (bioportfolio.com)
  • Overall with biosimilars the therapeutic agents are going to face more questions and need more education. (ecancer.org)
  • Ready-to-use therapeutic food (RUTF) is used to treat children suffering from severe acute malnutrition (SAM). (bioportfolio.com)
  • The present invention, in an exemplary embodiment, provides a therapeutic medical appliance, delivery device and method of use. (google.com)
  • The plug therapeutic medical appliances themselves combine many of the excellent characteristics of both silicone and metal therapeutic medical appliances while eliminating the undesirable ones. (google.com)
  • In particular, these therapeutic medical appliances are preferably self-expanding in nature and allow the predetermined differential selection of relative hardness/softness of regions of the therapeutic medical appliance to provide additional patient comfort. (google.com)
  • Therapeutic medical appliances are devices that are inserted into a vessel or passage to keep the lumen open and prevent closure due to a stricture, external compression, or internal obstruction. (google.com)
  • Applicants with GED® credentials should have a transcript of equivalency scores sent to CCRI from the General Equivalency Center. (ccri.edu)
  • High school diploma or general equivalency diploma (GED). (appone.com)
  • After a single acupoint tapping session of 30 to 60 min, significant therapeutic changes-in relation to comparison conditions-have been measured in brain-wave patterns, 116 cortisol levels, 27 the expression of genes involved in learning and emotional regulation, 76 frozen shoulder, 24 fear of small animals, 123 agoraphobia, 68 PTSD, 30 and various other psychological conditions. (researchgate.net)
  • Equivalencies from correspondence schools are not acceptable. (ccri.edu)
  • Prior to returning to Lurie Children's, Sheridan worked in therapeutic day schools, providing music therapy services to students of all ages with a diverse range of special needs and social-emotional needs. (luriechildrens.org)
  • The trademarked term of CPTG (Certified Pure Therapeutic Grade) is simply their marketing slogan designed to confuse consumers into thinking that it has been certified and that therapeutic grade essential oils exist. (lazymanandmoney.com)
  • In her research, she found that doTERRA was claiming that their products were certified as "therapeutic grade" by the FDA and that they show a seal with registered trademark CPTG (Certified Pure Therapeutic Grade) as proof. (lazymanandmoney.com)
  • And of course, he doesn't mention the fact that the purpose of therapeutic cloning is to help scientists cure disease and save lives. (prospect.org)
  • Children who participated in the PCOMS therapeutic sessions were able to give feedback on how they were doing and on how they found the therapy. (bio-medicine.org)