Drug Evaluation: Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.Drug Evaluation, Preclinical: Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.Drug Approval: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.Therapeutic Equivalency: 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.BooksDrugs, Generic: Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.Patents as Topic: Exclusive legal rights or privileges applied to inventions, plants, etc.Drug Labeling: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.Nonprescription Drugs: Medicines that can be sold legally without a DRUG PRESCRIPTION.Legislation, Drug: Laws concerned with manufacturing, dispensing, and marketing of drugs.Angina Pectoris: The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.Electronic Mail: Messages between computer users via COMPUTER COMMUNICATION NETWORKS. This feature duplicates most of the features of paper mail, such as forwarding, multiple copies, and attachments of images and other file types, but with a speed advantage. The term also refers to an individual message sent in this way.ReadingAcetanilides: Compounds based on N-phenylacetamide, that are similar in structure to 2-PHENYLACETAMIDES. They are precursors of many other compounds. They were formerly used as ANALGESICS and ANTIPYRETICS, but often caused lethal METHEMOGLOBINEMIA.Perhexiline: 2-(2,2-Dicyclohexylethyl)piperidine. Coronary vasodilator used especially for angina of effort. It may cause neuropathy and hepatitis.Blood Circulation: The movement of the BLOOD as it is pumped through the CARDIOVASCULAR SYSTEM.Nitroglycerin: A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.Judicial Role: The kind of action or activity proper to the judiciary, particularly its responsibility for decision making.Substance-Related Disorders: Disorders related to substance abuse.Criminal Law: A branch of law that defines criminal offenses, regulates the apprehension, charging and trial of suspected persons, and fixes the penalties and modes of treatment applicable to convicted offenders.Jurisprudence: The science or philosophy of law. Also, the application of the principles of law and justice to health and medicine.Law Enforcement: Organized efforts to insure obedience to the laws of a community.Supreme Court Decisions: Decisions made by the United States Supreme Court.Child Custody: The formally authorized guardianship or care of a CHILD.PubMed: A bibliographic database that includes MEDLINE as its primary subset. It is produced by the National Center for Biotechnology Information (NCBI), part of the NATIONAL LIBRARY OF MEDICINE. PubMed, which is searchable through NLM's Web site, also includes access to additional citations to selected life sciences journals not in MEDLINE, and links to other resources such as the full-text of articles at participating publishers' Web sites, NCBI's molecular biology databases, and PubMed Central.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Publishing: "The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing.MEDLINE: The premier bibliographic database of the NATIONAL LIBRARY OF MEDICINE. MEDLINE® (MEDLARS Online) is the primary subset of PUBMED and can be searched on NLM's Web site in PubMed or the NLM Gateway. MEDLINE references are indexed with MEDICAL SUBJECT HEADINGS (MeSH).Serial Publications: Publications in any medium issued in successive parts bearing numerical or chronological designations and intended to be continued indefinitely. (ALA Glossary of Library and Information Science, 1983, p203)Drug Interactions: The action of a drug that may affect the activity, metabolism, or toxicity of another drug.MichiganLawyers: Persons whose profession is to give legal advice and assistance to clients and represent them in legal matters. (American Heritage Dictionary, 3d ed)Marijuana Smoking: Inhaling and exhaling the smoke from CANNABIS.Superstitions: A belief or practice which lacks adequate basis for proof; an embodiment of fear of the unknown, magic, and ignorance.Hospitals, AnimalDog Diseases: Diseases of the domestic dog (Canis familiaris). This term does not include diseases of wild dogs, WOLVES; FOXES; and other Canidae for which the heading CARNIVORA is used.Schools, Veterinary: Educational institutions for individuals specializing in the field of veterinary medicine.Hospitals, Teaching: Hospitals engaged in educational and research programs, as well as providing medical care to the patients.Amazona: One of the largest genera of PARROTS, ranging from South American to Northern Mexico. Many species are commonly kept as house pets.Horse Diseases: Diseases of domestic and wild horses of the species Equus caballus.Cat Diseases: Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used.European Union: The collective designation of three organizations with common membership: the European Economic Community (Common Market), the European Coal and Steel Community, and the European Atomic Energy Community (Euratom). It was known as the European Community until 1994. It is primarily an economic union with the principal objectives of free movement of goods, capital, and labor. Professional services, social, medical and paramedical, are subsumed under labor. The constituent countries are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. (The World Almanac and Book of Facts 1997, p842)Ectopia Cordis: A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.EuropeCommotio Cordis: A sudden CARDIAC ARRHYTHMIA (e.g., VENTRICULAR FIBRILLATION) caused by a blunt, non-penetrating impact to the precordial region of chest wall. Commotio cordis often results in sudden death without prompt cardiopulmonary defibrillation.GreeceInternational Cooperation: The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.Animal Testing Alternatives: Procedures, such as TISSUE CULTURE TECHNIQUES; mathematical models; etc., when used or advocated for use in place of the use of animals in research or diagnostic laboratories.MassachusettsHospitals, General: Large hospitals with a resident medical staff which provides continuous care to maternity, surgical and medical patients.Mental Disorders: Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.BostonArchivesPsychiatric Status Rating Scales: Standardized procedures utilizing rating scales or interview schedules carried out by health personnel for evaluating the degree of mental illness.

Bacteriologic cure of experimental Pseudomonas keratitis. (1/1937)

Two long-term therapy trials with high concentrations of antibiotic were carried out to determine the duration of therapy required to achieve bacteriologic cure of experimental Pseudomonas keratitis in guinea pigs. In the first study, corneas still contained Pseudomonas after 4 days of continual topical therapy with either tobramycin 400 mg/ml, amikacin 250 mg/ml, ticarcillin 400 mg/ml, or carbenicillin 400 mg/ml. In an 11-day trial of topical therapy with tobramycin 20 mg/ml, 34 of 36 corneas grew no Pseudomonas after 6 or more days of therapy. The bacteriologic response to therapy in this model occurred in two phases. About 99.9% or more of the organisms in the cornea were killed in the first 24 hr of therapy. The numbers of bacteria remaining in the cornea declined gradually over the next several days until the corneas were sterile. Optimal antibiotic therapy may include two stages: initial intensive therapy with high concentrations of antibiotic applied frequently to achieve a large rapid decrease in numbers of organisms in the cornea, followed by prolonged, less intensive therapy to eradicate organisms and prevent relapse.  (+info)

A tale of two (or more) cities: geographic transferability of pharmacoeconomic data. (2/1937)

The economic evaluation of a new medicine often must be based on data gathered in multiple countries. Because replication of trials is an expensive and inefficient undertaking, analysts need to determine the validity of transferring cost-effectiveness data from one country to another. Threats to transferring data involve differences among countries with regard to demography and epidemiology of disease, clinical practice and conventions, incentives to and regulation of healthcare providers, relative price levels, consumer preferences, and opportunity cost of resources. Because of these differences, a drug can be cost-effective in one country and not cost-effective in another. Adapting a cost-effectiveness study conducted in one country to another country requires careful scrutiny of the relevance of comparators, practice patterns, and relative price weights.  (+info)

Use of an intravenous contrast agent (Optison) to enhance echocardiography: efficacy and cost implications. Optison Multicenter Study Group. (3/1937)

OBJECTIVE: To compare the overall diagnostic costs associated with non-contrast and contrast echocardiography. STUDY DESIGN: Phase III clinical trial. PATIENTS AND METHODS: In a secondary analysis of data from a phase III clinical trial of the intravenous contrast agent Optison, we compared the costs associated with obtaining a diagnosis in 203 patients who underwent non-contrast and contrast echocardiography. Costs for the initial test and any follow-up tests were derived from adjusted Medicare charges and a transition-1 microcost accounting system. RESULTS: Diagnostic yield from echocardiograms was 87% with the use of Optison (3 mL) and 49% when no contrast agent was used (P < 0.001). Because technically inadequate echocardiograms were more common in the non-contrast group, follow-up testing was recommended for 42% of patients in this group compared with 12% of those who had undergone a contrast-enhanced echocardiogram (P < 0.001). Although use of Optison increased the initial diagnostic cost by $125, overall costs were 17% lower when Optison was used (P < 0.0001). Use of Optison also resulted in a 17% to 70% decrease in confirmatory transesophageal echocardiography, catheterization, and nuclear studies. Optison improved diagnostic accuracy by 2.7-fold in patients with an initial non-diagnostic echocardiogram, resulting in a substantial cost savings of $269 per patient.  (+info)

Clinical trial experience by simulation: a workshop report. (4/1937)

A new computer program for experimental design simulation was used in a three-day postgraduate workshop on clinical trials. Participants were given information on a fictitious new drug and asked to design a trial to evaluate it. On the first day they reviewed the data and designed a protocol, and results for these specifications were generated on the computer. The second day was spent analysing results, and on the last day the findings of the different studies were presented at a symposium. Flexibility of the program ensured a high degree of realism in all trials and emphasised the influence of design on results and conclusions.  (+info)

Research strategies for behavioral teratology studies. (5/1937)

Several compelling aruguments have been advanced in support of expanding the use of "behavioral teratology" evaluations as routine components of toxicologic screening procedures. As a basis for development of effective behavioral teratology screening approaches, a conceptual framework is presented which interrelates: (1) changes in relative functional brain capacity with age, (2) possible times and durations of exposures to environmental insults, and (3) various types of toxicity testing procedures carried out at appropriate time points in relation to different exposure period. Within the context, several research strategies for behavioral teratology studies are concisely posed and evaluated. These include: (1) clinical hypothesis testing, where particular effect(s) of a given agent are evaluated based on hypotheses derived from clinical or epidemiological observations; (2) comprehensive screening approaches, where multifaceted, long-term longitudinal neurobehavioral evaluations are employed to assess whether any of a large number of possible deletarious effects are exerted by an agent and at what threshold exposure levels; (3) alternative screening heuristics, by which adequate assessments of neurobehavioral toxicity of various agents may be accomplished without completion of more exhaustive, but also more expensive and time-consuming comprehensive screening protocols.  (+info)

Randomized double-blind placebo-controlled trial of homoeopathic 'proving' for Belladonna C30. (6/1937)

Homoeopathic drug pictures are developed by recording the symptomatic effects of homoeopathic remedies given to healthy volunteers (a 'proving'). In a double-blind randomized controlled trial we tested the hypothesis that individuals using an infinitesimal dilution of Belladonna (thirtieth potency, C30) would record more true symptoms, on a questionnaire that contained both true and false Belladonna proving symptoms, than those receiving placebo. 60 volunteers entered the study and 47 completed data collection. We were unable to distinguish between Belladonna C30 and placebo using our primary outcome measure. For the secondary outcome measure we analysed the number of individuals who proved to the remedy according to our predefined criteria: 4 out of 19 proved in the Belladonna C30 group and 1 out of 27 in the placebo group (difference not statistically significant). This pilot study does not demonstrate a clear proving reaction for Belladonna C30 versus placebo, but indicates how the question might be further investigated.  (+info)

Cutaneously applied 4-hydroxytamoxifen is not carcinogenic in female rats. (7/1937)

Tamoxifen is widely used to treat oestrogen-dependent carcinoma of the breast. Previous long-term studies have shown that oral administration of tamoxifen induces hepatoproliferative lesions and hepatocellular tumours in rats. 4-hydroxytamoxifen is an active metabolite of tamoxifen undergoing clinical evaluation for the treatment of various non-malignant breast diseases by topical application. In the present study, 4-hydroxytamoxifen was administered daily by cutaneous application for 101 weeks to groups of 50 female Sprague-Dawley rats at 20, 140 or 1000 microg/kg/day. The product was applied with no occlusive bandage and oral ingestion was avoided by application of an Elizabethan collar for 6 h after administration. Treatment with 4-hydroxytamoxifen was clinically well tolerated and induced changes such as decreased food consumption and body weight gain, uterine and ovarian atrophy, mucification of vaginal epithelium and reduced mammary development, all of which were attributed to its pharmacological action. Mortality was significantly lower in the treated animals. The number of animals with palpable masses was similarly reduced. The incidence of mammary tumours and hypophyseal tumours was markedly lower in 4-hydroxytamoxifen-treated animals. The incidence of chronic tubulo-interstitial nephropathies, a common cause of mortality, was also lowered. There was no evidence of a carcinogenic action of 4-hydroxytamoxifen on the liver, genital organs or skin. Plasma levels of 4-hydroxytamoxifen were stable over the duration of the study and were proportional to the administered dose, exceeding clinical plasma levels by 60-fold at the high dose-level. In conclusion, 4-hydroxytamoxifen is not carcinogenic in the rat and reduces the incidence of spontaneous mammary and hypophyseal tumours.  (+info)

Evaluation of the renal effects of an antisense phosphorothioate oligodeoxynucleotide in monkeys. (8/1937)

Antisense phosphorothioate oligodeoxynucleotides are therapeutic agents that provide target specificity resulting from Watson-Crick base pairing. However, there are nonspecific effects that in some instances result in toxicity. These compounds accumulate in the kidney and induce renal proximal tubular degeneration at high doses. The relationship between accumulation of phosphorothioate oligodeoxynucleotides in the kidney, indicators of renal toxicity, and histomorphology were investigated in rhesus monkeys. Monkeys received vehicle or an escalating dose regimen of 3, 10, 40, and 80 mg/kg of ISIS 2105 and were then evaluated for changes in clinical pathology indices, urinalysis parameters, and renal histopathology. Urinalysis revealed an increase in protein levels and a slight increase in blood content following the third 40 mg/kg dose and continuing through the 80 mg/kg doses, whereas other urinary markers of renal toxicity were unchanged. Creatinine clearance was slightly decreased in monkeys during the 80 mg/kg dose cycle. Granulation in the cytoplasm of proximal tubular epithelial cells was evident by microscopic examination of kidney and was present at all doses examined and increased with dose. Immunohistochemical staining localized the oligodeoxynucleotide within these granules. Histopathologic changes consisting of minimal to moderate tubular degeneration were present only at the higher doses of 40 and 80 mg/kg and at high tissue concentrations, and these changes occurred concurrent with functional alterations, whereas lower doses (< or = 10 mg/kg) did not affect a pathologic or functional change.  (+info)

  • This training seminar is an overview of the key evaluation principles found in the NHTSA Drug Evaluation and Classification Program (DECP-DRE) led by Lance Platt and team-taught with Fran Gengo, PHARM.D. The course will provide a look at pharmacology from the law enforcement and pharmacologist points of view. (eventbrite.com)
  • Participants will receive a Certification of their mastery of "An Overview of the NHTSA Drug Evaluation and Classification Program (DRE) 2018 Curriculum. (eventbrite.com)
  • to ascertain the epidemiological characteristics, clinical symptoms, and evolution of drug-induced hepatitis over the last 22 years. (isciii.es)
  • All patients in our department diagnosed with having drug-induced hepatitis were studied analyzing epidemiological (age, sex, cases per year, hospitalization) and clinical features (previous liver disease, hepatic symptoms, laboratory results), and follow-up (complete recovery or chronicity). (isciii.es)
  • Thus, we carried out a study of cases with drug-induced hepatitis diagnosed in our service over the past 22 years, and analyzed the epidemiological characteristics and drugs to which the development, clinical manifestation and evolution are attributed. (isciii.es)
  • The FDA requires a four phased series of clinical trials for testing drugs. (wikipedia.org)
  • In 1966, the division was reorganized to create the Office of New Drugs, which was responsible for reviewing new drug applications and clinical testing of drugs. (wikipedia.org)
  • Generally, 10-20 years and several billion dollars are required to launch a new drug that successfully passes preclinical and clinical tests. (biotechniques.com)
  • Two-dimensional (2D) cell-based assays are often performed before the clinical phases of drug development. (biotechniques.com)
  • In the first part of this investigation, the aim was to analyze the use of drugs in the Pediatric Clinic of the Clinical Center Banjaluka during three years (1996, 1999, and 2000), and to compare obtained data with the principles of modern pharmaco therapies. (unicef.org)
  • Using data from the information center of the Clinical Center Banjaluka, we carried out the analysis on the use of drugs within the Pediatric Clinic during years 1996, 1999 and 2000. (unicef.org)
  • edition of Histopathology of Preclinical Toxicity Studies is now completely in full color and continues to describe the pathology found in drug safety studies in laboratory animals with an evidence-based discussion of the relevance of these findings to the clinical investigation of new drugs for humans. (worldcat.org)
  • No clinical consequences resulting from drug incompatibilities were shown in this study. (nih.gov)
  • In addition, this study will provide a proof-of-principle evaluation of dried blood spot technology as a method to measure drug concentrations in blood samples collected from clinical studies. (clinicaltrials.gov)
  • A distribution characterization that is of high importance as most current used anti-tuberculosis drugs were introduced into clinical use without considering the pharmacokinetic properties influencing drug distribution to the site of action. (diva-portal.org)
  • Sponsors of products that combine two or more previously marketed drugs or biologics may be able to rely on existing clinical and nonclinical safety data before proceeding with clinical trials of the proposed combination therapy, according to a new FDA guidance. (fdanews.com)
  • Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. (wisepress.com)
  • It is well known that many valuable safety information of TCM comes directly from clinical use, which can be perceived as more important reference for TCM safety evaluation, to some extent, even than that from animals. (frontiersin.org)
  • However, the value of previously obtained clinical information will be weakened for various reasons in the development of novel drugs of TCM. (frontiersin.org)
  • Compared with the previous clinical application, the changes of medicinal material source, the prescription composition, extraction technology, selected population, administration mode, dosage, excipients, can lead to functional changes of drug ingredients, which may affect the safety of novel drugs. (frontiersin.org)
  • The ultimate goal of drug safety evaluation is to reduce the safety risk of clinical medication, rather than experimental animals. (frontiersin.org)
  • So in order to predict the clinical toxicity of drugs more accurately, can we evaluate with morbid animal model? (frontiersin.org)
  • She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association-Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. (wiley.com)
  • These guidelines are based on years of clinical experience to help handle the issues related to each individual's addiction and patterns of drug use. (addictionnomore.com)
  • One promising antitumor drug candidate is 20(S)-protopanaxadiol (PPD), although its clinical application is limited by low water solubility and poor bioavailability after oral administration. (sigmaaldrich.com)
  • The main aim is to accelerate the uptake of human-based in silico methodologies for evaluation of cardiac drug safety and efficacy in industry, regulatory and clinical settings. (nc3rs.org.uk)
  • 3) Evaluation studies to compare in silico human-based predictions to clinical outcomes, current animal methods, and in vitro methods including stem cell derived cardiomyocytes. (nc3rs.org.uk)
  • Finally, specific examples of the translation of in vitro findings to the in vivo effects are discussed to link the current understanding of the impact of drug transporters to clinical pharmacology. (eurekaselect.com)
  • The rising prevalence of serious fungal infections and antifungal drug resistance has created an increased demand for reliable methods of in vitro testing of antifungal agents that can assist in their clinical use. (asm.org)
  • He finds evidence of a number of beneficial changes in reimbursement processes, including the measurement of more meaningful clinical endpoints and increased engagement between manufacturers, drug regulators and payers. (healthcanal.com)
  • A consistent finding across studies of reimbursement decisions is that economic considerations have been influential, second only to the strength of the clinical evidence for the drug of interest. (healthcanal.com)
  • The Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs. (wikipedia.org)
  • On June 30, 2003, FDA transferred some of the therapeutic biological products that had been reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). (fda.gov)
  • Nano-pharmaceuticals, which are derived by application of nanotechnology in medical therapeutics are expected to bring about a revolution in treatment strategies as they would enable target specific delivery of drugs and therapeutic molecules and thus offer higher efficacy and lower toxicity in many disease conditions. (thehindubusinessline.com)
  • ATC - Anatomical Therapeutic Chemical classification of drug, and systems of DDD - Defined Daily Dose as the measurement units are officially accepted and recommended by WHO as a toll for the follow-up on the use of drugs among a certain population or health care institution. (unicef.org)
  • The share of humanitarian assistance in the supply of drugs in the Clinic for children's diseases during the observed years was significant and thus, it had a major impact on the therapeutic choice made by medical doctors. (unicef.org)
  • This developed approach has practical significance and can effectively guide drug selection and therapeutic evaluation for personalized medicine. (rsc.org)
  • Unfortunately with time has come loss of therapeutic efficacy due to the growing prevalence of drug resistant strains [ 4 ]. (mdpi.com)
  • Self-Microemulsifying Drug Delivery Systems: An Attractive Strategy for Enhanced Therapeutic Profile. (ebscohost.com)
  • Failure to attain intended therapeutic effect of the poor water soluble drugs by. (ebscohost.com)
  • Cyclodextrin solubilization of carbonic anhydrase inhibitor drugs: formulation of dorzolamide eye drop microparticle suspension," European Journal of Pharmaceutics and Biopharmaceutics , vol. 76, no. 2, pp. 208-214, 2010. (hindawi.com)
  • S. BANDARI, C.M. EAGA, A. THADISHETTY i M.R. YAMSANI, "Formulation and evaluation of multiple tablets as a biphasic gastroretentivefloating drug delivery system for fenoverine", Acta Pharmaceutica , vol.60, br. (srce.hr)
  • The report provides information on the developers, phase of development of candidate drugs / therapies, mechanism of action, route of administration, type of molecule, type of formulation and the dose frequency of the various therapies. (benzinga.com)
  • The prolonged residence of drug formulation in the nasal cavity is of utmost importance for intranasal drug delivery. (omicsonline.org)
  • Efavirenz is a poorly water soluble drug with aqueous solubility 4 µg/mL and oral bioavailability 40-45%, having non-nucleoside reverse transcriptase inhibitor (NNRTI) antiretroviral activity. (ebscohost.com)
  • Using a microfluidic platform that connects engineered tissues from up to 10 organs, the researchers can accurately replicate human organ interactions for weeks at a time, allowing them to measure the effects of drugs on different parts of the body. (eurekalert.org)
  • Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers. (nih.gov)
  • For 9 of the 12 drugs coadministered with patiromer, there were no clinically significant drug-drug interactions. (nih.gov)
  • For 3 drugs (ciprofloxacin, levothyroxine, and metformin), a 3-hour separation between patiromer and their administration resulted in no clinically significant drug-drug interactions. (nih.gov)
  • Microspheres were characterised by Fourier transform infrared (FTIR) spectroscopy and differential scanning calorimetry (DSC) to confirm the absence of chemical interactions between drug and polymer and to know the formation of microspheres structure. (unboundmedicine.com)
  • Evaluation of drug-drug interactions among patient. (who.int)
  • Introduction: The risk of drug-drug interactions (DDIs) is high in patients with chronic kidney disease (CKD) necessitating dose adjustments or the avoidance of drug combinations. (who.int)
  • The objective of this work is to test the ability of a range of novel drugs, reversed-quinolines, and resistance-reversers to interact with mutant PfCRT, and to provide insights into the structural features important for these interactions. (edu.au)
  • MIT engineers have developed new technology that could be used to evaluate new drugs and detect possible side effects before the drugs are tested in humans. (eurekalert.org)
  • These chips could also be used to evaluate antibody drugs and other immunotherapies, which are difficult to test thoroughly in animals because they are designed to interact with the human immune system. (eurekalert.org)
  • The center has around 1,300 employees in "review teams" that evaluate and approve new drugs. (wikipedia.org)
  • Twelve randomized, open-label, 3-period, 3-sequence crossover studies were conducted in healthy volunteers to evaluate the effect of patiromer (perpetrator drug) on absorption and single-dose pharmacokinetics (PK) of drugs (victims) that might be commonly used with patiromer. (nih.gov)
  • In Part 2, the study will evaluate the quantitative performance of the cocktail by examining the effect of select inhibitors on the pharmacokinetics of respective probe drugs when the probe drugs are administered alone versus when administered in the cocktail. (clinicaltrials.gov)
  • Global drug delivery company, pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) announced that it has entered into an evaluation agreement with an undisclosed large global medical device company to evaluate cardiovascular delivery of drugs using pSivida's drug delivery technologies. (nanotech-now.com)
  • This apparatus was used to evaluate in a double-blind, parallel fashion the effect of three different antihypertensive drugs and of a placebo on radial artery compliance. (ahajournals.org)
  • The particular interest in this work was to design, synthesise and evaluate in situ forming drug eluting hydrogels, which have the potential to ameliorate the healing of cardiovascular diseases. (diva-portal.org)
  • To evaluate drug safety, there are several deficiencies in current standard animal models, and we should pay more attention to morbid animal models. (frontiersin.org)
  • If you answer 'yes' to one or more of the above questions, it does not necessarily imply a chemical dependency problem, three or more 'yes' answers suggest that you should more closely evaluate your drug and or alcohol use. (hvrc.com)
  • This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). (centerwatch.com)
  • To evaluate tolerability and safety of SAR408701 in combination with other anti-tumor drug according to the IMP related DLTs to determine RD of SAR408701 in Japanese patients with locally advanced or metastatic colorectal cancer (CRC) (combination part). (clinicaltrials.gov)
  • China Food and Drug Administration (CFDA) is planning to help set up a drug evaluation center in Shanghai to cut the time it takes to evaluate and approve new medicines, CCTV reports. (raps.org)
  • Conclusion: To evaluate drugs for the treatment of hypertension several key variables including the blood pressure lowering effect, side effects, compliance/persistence with treatment, as well as drug costs and direct and indirect costs of medical care have to be considered. (uni-muenchen.de)
  • From the perspective of many adults, all adolescents who use drugs, including alcohol and tobacco, have a drug problem. (healio.com)
  • The main recreational drugs for the adolescent population are alcohol and marijuana. (healio.com)
  • Driving under the Influence of Drugs, Alcohol and Medicines (DRUID Project) 6th Framework Programme, "Analytical evaluation of oral fluid screening devices and preceding selection procedures," Deliverable 3.2.2 (Finland: National Institute for Health and Welfare, March 30, 2010), p. 95. (drugwarfacts.org)
  • Has anyone ever suggested you quit or cut back on your drug/alcohol use? (hvrc.com)
  • On occasion, do you feel uncomfortable if alcohol or your drug is not available? (hvrc.com)
  • Have you been charged with an alcohol or drug related crime in Texas, or is your work or school recommending that you get an evaluation for drugs or alcohol? (addictionnomore.com)
  • What is the purpose of an alcohol evaluation? (addictionnomore.com)
  • The evaluation is designed not only to serve as a determining factor as to rehabilitation requirements but also helps the treatment center determine what would better help the defendant that is facing charges for drug or alcohol related crimes. (addictionnomore.com)
  • Starting the process for a drug or alcohol evaluation for a DWI conviction is pretty straight forward but there are a few things to consider before starting the process. (addictionnomore.com)
  • In this section, we discuss the determination of whether the individual's continuing disability is affected by DAA, and whether MI would occur if the individual were to stop using drugs or alcohol. (ssa.gov)
  • To determine whether DAA is material, the DE must determine whether we would still find an individual disabled if he or she stopped using drugs or alcohol (See SSR-13-2p, Question 2 ). (ssa.gov)
  • DAA is material to the determination of continuing disability if the individual would not meet our definition of disability if he or she were not using drugs or alcohol based on the 7-step process in DI 28005.045 . (ssa.gov)
  • Medical improvement (MI) is any decrease that would occur in the medical severity of the impairment(s) (considered in the current determination of continuance), if the individual were to stop using drugs or alcohol. (ssa.gov)
  • The document, which covers all the aspects of evaluation from the definition and categorisation of nanopharmaceuticals to pharma covigilance of the new set of therapeutics, has been prepared as a joint project by the Department of Biotechnology in the Ministry of Science and Technology, and Indian Council of Medical Research and Central Drugs Standard Control Organisation in the Ministry of Health and Family Welfare. (thehindubusinessline.com)
  • As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. (healthfinder.gov)
  • In translational research, disease models in preclinical studies are used as media for discovery of drugs or novel therapeutics. (unt.edu)
  • The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. (wikipedia.org)
  • This lag, in part, has been due to the confusion of proper and expeditious methods to define safety and efficacy of such agents so that the United States regulatory agency (Food and Drug Administration) could approve the use of such agents by clinicians. (springer.com)
  • A number of advocates have called on the Food and Drug Administration to consider the cost-effectiveness of new drugs as a part of the approval process and for Medicare to begin negotiating with pharmaceutical companies to obtain lower prices. (modernhealthcare.com)
  • As it stands, CFDA has 120 people working on medicine evaluations, an order of magnitude less than the US Food and Drug Administration. (raps.org)
  • The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. (unboundmedicine.com)
  • If a drug appears in the quarterly report, it means we've begun an analysis to determine whether there is a safety problem that requires further evaluation," said Gerald Dal Pan, M.D., M.P.H., director of surveillance and epidemiology for the FDA's drugs division. (medpagetoday.com)
  • Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people. (wikipedia.org)
  • The vast number of new beta blocker and calcium antagonist agents being developed, as well as the long-term use abroad of many new drugs, has raised important questions as to how relative safety and efficacy of such agents can be determined to facilitate availability in the United States. (springer.com)
  • Therefore, when establishing drug efficacy it is important not to rely only on experiments in primary tumour models but to also study the test compound in metastasis models. (pharmaceutical-technology.com)
  • To learn more about drug efficacy evaluation in bone metastasis models, including breast cancer models with MDA-MB-231, MCF-7, and BT-474 cells, prostate cancer moseld with PC-3 and LNCaP cells, and tumour detection parameters. (pharmaceutical-technology.com)
  • To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity. (clinicaltrials.gov)
  • Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). (ovid.com)
  • In vitro evaluation of dissolution behavior for a colon-specific drug delivery system (CODES) in multi-pH media using United States Pharmacopeia apparatus II and III. (sigmaaldrich.com)
  • Apparatus III was demonstrated to be more convenient and efficient than apparatus II by providing various programmable options in sampling times, agitation rates, and medium changes, which suggested that the apparatus III approach has better potential for in vitro evaluation of colon-specific drug delivery systems. (sigmaaldrich.com)
  • The first list includes only products regulated by the FDA's Center for Drug Evaluation and Research, but Dr. Dal Pan did not rule out the possibility that vaccines, biologic agents, and medical devices could be included in future reports. (medpagetoday.com)
  • citation needed] The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year[citation needed]. (wikipedia.org)
  • Within the first year, the FDA's Drug Division, the predecessor to CDER, received over 1200 applications. (wikipedia.org)
  • In 1982, when the beginning of the biotechnology revolution blurred the line between a drug and a biologic, the Bureau of Drugs was merged with the FDA's Bureau of Biologics to form the National Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. (wikipedia.org)
  • On June 19, a U.S. manufacturer of valsartan products, Prinston Pharmaceuticals Inc., contacted the FDA's Center for Drug Evaluation and Research (CDER) about its products containing valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical Co. (ZHP). (benzinga.com)
  • The 3rd edition of this successful reference book contains an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. (springer.com)
  • Effect of antihypertensive drugs. (ahajournals.org)
  • Antihypertensive drugs acting by different mechanisms may have different effects on the mechanical properties of large arteries. (ahajournals.org)
  • This review explores the blood pressure reduction and persistence with treatment of antihypertensive drugs and the cost consequences of poor persistence with pharmaceutical interventions in arterial hypertension. (uni-muenchen.de)
  • bioabsorbable drug eluting stents developed by Bioabsorbable Vascular Solutions, an entrepreneurial subsidiary of Guidant Vascular Intervention established in 2003 in the Silicon Valley. (medgadget.com)
  • These stents are designed to be fully absorbed by vascular tissue following the restoration of blood flow and drug elution in patients with coronary artery disease. (medgadget.com)
  • Now second generation drug-eluting stents are proving to be even more beneficial. (reachmd.com)
  • How are these second generation drug-eluting stents further reducing the risk of late stent thrombosis, myocardial infarction and repeat revascularization? (reachmd.com)
  • Dr. Richard Lange, professor and executive vice chairman of medicine at the University of Texas Health Science Center, in San Antonio, Texas, discusses the structural and molecular differences between first and second generation drug-eluting stents. (reachmd.com)
  • Are second generation drug-eluting stents enough of an improvement upon their first generation counterparts to warrant the higher cost? (reachmd.com)
  • When developing a new drug, researchers identify drug targets based on what they know about the biology of the disease, and then create compounds that affect those targets. (eurekalert.org)
  • It is desired to obtain their spatial information, single cell localization, or organelle conditions quantitatively and combine this multiparametric quantitative information for the evaluation of 3D cell culture models such that new insights of compounds can be attained. (biotechniques.com)
  • With these tasks the epithelial integrity of the cornea and the homeostasis of the retina will be evaluated, and the mechanisms of adverse drug reactions (ADRs) of reference compounds and penetration enhancers (PEs) determined. (europa.eu)
  • Our ultimate goal is to design a series of novel anti-helicase compounds as drug candidates against the endemic GGE virus while the inhibitory activity of our novel compounds will be evaluated biologically. (igi-global.com)
  • Withdrawal due to cardiotoxicity has increased from 5.1 to 33%, including compounds to treat cardiovascular problems as well as drugs not intended to affect the heart such as antihistamines. (nc3rs.org.uk)
  • Drug transporters play an important role in the absorption, distribution, excretion and toxicity of both endogenous and exogenous compounds. (eurekaselect.com)
  • Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling. (wikipedia.org)
  • CDER reviews New Drug Applications to ensure that the drugs are safe and effective. (wikipedia.org)
  • In 1987, under Commissioner Frank Young, CDER and the Center for Biologics Evaluation and Research (CBER) were split into their present form. (wikipedia.org)
  • The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. (healthfinder.gov)
  • This aggregate report is prepared in a format that will allow laboratory personnel to compare their DST results with those obtained by other participants using the same methods and drugs, for each isolate. (cdc.gov)
  • and (3) use flawed data-collection methods, such as drug court participants' self-reported surveys. (drugwarfacts.org)
  • In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. (wisepress.com)
  • Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work. (wisepress.com)
  • Chemical drug analysis techniques vary considerably, from simple colorimetric reagents to advanced forensic methods such as gas chromatography/mass spectrometry (GC/MS). (frontiersin.org)
  • Methods: We have searched the literature for data on blood pressure lowering effects of different antihypertensive drug classes and agents, on persistence with treatment, and on related costs. (uni-muenchen.de)
  • Guidant has completed extensive preclinical studies on its bioabsorbable stent, gathering data on safety, drug dosing, and the mechanical properties of the stent. (medgadget.com)
  • The research comprises three major components: process evaluation, impact evaluation, and a cost-benefit analysis. (umich.edu)
  • The process evaluation describes how the 23 drug court sites vary in program eligibility, supervision, treatment, team collaboration, and other key policies and practices. (umich.edu)
  • The MADCE study entailed several components, including a survey of Adult Drug Courts, a rigorous site selection process for the evaluation, and the collection of process, outcome, impact, and cost data across the evaluation sites. (umich.edu)
  • With the rapid advancement of biologically-derived treatments, the FDA has stated that it is working to modernize the process of approval for new drugs. (wikipedia.org)
  • CESS regulatory publications include guidelines, information packets, and Federal Register notices relative to the drug approval process. (healthfinder.gov)
  • The UK National Institute for Health and Care Excellence (NICE) board has approved changes to the drug evaluation process. (pharmaceutical-technology.com)
  • The DE determines (using the 8-step CDR evaluation process shown in DI 28005.010 ) that disability continues considering all impairments, including DAA. (ssa.gov)
  • The DE will assess the significance of the projected changes recorded by the MC/PC and his or her conclusion regarding MI, following the sequential evaluation process outlined in DI 28005.045 . (ssa.gov)
  • This chart outlines the DAA material CDR evaluation process (using the medical improvement review standard (MIRS)), effective upon enactment of Public Law (P.L. 104-121), for all Title II beneficiaries and Title XVI recipients age 18 or older. (ssa.gov)
  • Follow the CDR evaluation process shown in DI 28005.010 to determine if disability continues before proceeding to step 1 of the following chart. (ssa.gov)
  • Information and guidance to order other regulatory manuals, directories, or drug evaluation reports are also available. (healthfinder.gov)
  • The in situ gelation upon contact with nasal mucosa was conferred via the use of the thermogelling Methyl cellulose whereas mucoadhesion and drug release enhancement were modulated via the use of sodium alginate and polyethylene glycol polymers respectively. (omicsonline.org)
  • The in vitro tests performed for mucoadhesive strength and drug diffusion showed that nasal in situ gelling formulations prepared are having good mucoadhesive strength with nearly 100% drug diffusion within 4 hours. (omicsonline.org)
  • However, adverse drug reactions (ADRs) to antibiotics occur more commonly and discrete types of ADRs may differ in CF patients compared to the general population. (medworm.com)
  • In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases. (unboundmedicine.com)
  • Participants will receive a Certification of their mastery of "An Overview of the NHTSA Drug Evaluation and Classification Program (DRE) 2018 Curriculum. (eventbrite.com)
  • The 'Novel Drugs and Smart Devices for Respiratory Disorders, 2018-2030' report has been added to ResearchAndMarkets.com's offering. (benzinga.com)
  • The Novel Drugs and Smart Devices for Respiratory Disorders, 2018-2030' report provides a comprehensive study on the current landscape of novel therapies and smart devices being evaluated for the treatment of asthma, COPD and cystic fibrosis. (benzinga.com)
  • 2018). In silico evaluation of arrhythmia. (nc3rs.org.uk)
  • to characterise drug-induced unwanted changes in the cornea and retina at cellular and molecular level in standardised cell cultures. (europa.eu)
  • The brands were tested for physicochemical evaluation and in vitro dissolution studies in different medium like 0.07N HCl, distilled water, 0.1N HCl of pH 1.2 and phosphate buffers of pH 4.5 and pH 6.8. (ijpsonline.com)
  • Thus the present study was undertaken with the aim to perform comparative pharmaceutical evaluation of four different brands of cefuroxime axetil 125 mg tablets included physical appearance and parameters along with dissolution in different medium was performed. (ijpsonline.com)
  • Thirdly, some factors may affect the ingredients of novel drugs of TCM compared with that applied historically. (frontiersin.org)
  • The growing crisis around HIV testing and treatment and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator) led to the split. (wikipedia.org)
  • The incompatibilities included furosemide (Lasix), a drug in alkaline solution and Vamina-Glucose, a total parenteral nutrition solution. (nih.gov)
  • Furosemide,lisinopril and amlodipine were the most frequently prescribed drugs and had the greatest likelihood for nephrotoxicity. (who.int)
  • Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis complex (MTBC) drug susceptibility testing survey sent to participants in February 2020. (cdc.gov)
  • Evaluation of rapid radiometric method for drug susceptibility testing of Mycobacterium tuberculosis. (asm.org)
  • A total of 106 isolates of Mycobacterium tuberculosis were tested for drug susceptibility by the conventional 7H11 plate method and by a new rapid radiometric method using special 7H12 liquid medium with 14C-labeled substrate. (asm.org)
  • It lists 20 drugs, along with the associated adverse events that triggered the evaluations. (medpagetoday.com)
  • After adjusting for factors such as progression-free survival, potential adverse events, quality of life and dosing, the researchers concluded that Genentech's bevacizumab, priced at $9,324 for a course of treatment, was more cost-effective than Bristol-Myers Squibb Co.'s cetuximab, priced at $20,856, and should be considered the preferred drug. (modernhealthcare.com)
  • The European Commission was tasked to draw up annual progress reviews on the implementation of the action plans, for consideration by the Council, and to conduct the final evaluation of the EU drugs action plan (2005-08) . (europa.eu)
  • The court may have provided you with a copy of the treatment centers in your county that are certified by the courts to conduct the evaluations. (addictionnomore.com)
  • In February 2010, the National Institute for Occupational Safety and Health (NIOSH) received a confidential employee request for a Health Hazard Evaluation (HHE) at a veterinary teaching hospital that provides routine care and oncology services to large and small animals. (cdc.gov)
  • At least one company claims to have been waiting 10 years to have its oncology drug application processed. (raps.org)