Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect.
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)
Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.
Hard or soft soluble containers used for the oral administration of medicine.
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Dosage forms of a drug that act over a period of time by controlled-release processes or technology.
The preparation, mixing, and assembling of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814)
The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients.
Homogeneous liquid preparations that contain one or more chemical substances dissolved, i.e., molecularly dispersed, in a suitable solvent or mixture of mutually miscible solvents. For reasons of their ingredients, method of preparation, or use, they do not fall into another group of products.
Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.
The chemical and physical integrity of a pharmaceutical product.
The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)
Methylester of cellulose. Methylcellulose is used as an emulsifying and suspending agent in cosmetics, pharmaceutics and the chemical industry. It is used therapeutically as a bulk laxative.
A nitroimidazole antiprotozoal agent used in ameba and trichomonas infections. It is partially plasma-bound and also has radiation-sensitizing action.
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
The giving of drugs, chemicals, or other substances by mouth.
Substances made up of an aggregation of small particles, as that obtained by grinding or trituration of a solid drug. In pharmacy it is a form in which substances are administered. (From Dorland, 28th ed)
A chromatography technique in which the stationary phase is composed of a non-polar substance with a polar mobile phase, in contrast to normal-phase chromatography in which the stationary phase is a polar substance with a non-polar mobile phase.
Method of using a polycrystalline powder and Rietveld refinement (LEAST SQUARES ANALYSIS) of X-RAY DIFFRACTION or NEUTRON DIFFRACTION. It circumvents the difficulties of producing single large crystals.
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 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.
Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.
Colloids with liquid continuous phase and solid dispersed phase; the term is used loosely also for solid-in-gas (AEROSOLS) and other colloidal systems; water-insoluble drugs may be given as suspensions.
Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.
The number of copies of a given gene present in the cell of an organism. An increase in gene dosage (by GENE DUPLICATION for example) can result in higher levels of gene product formation. GENE DOSAGE COMPENSATION mechanisms result in adjustments to the level GENE EXPRESSION when there are changes or differences in gene dosage.
Systems for the delivery of drugs to target sites of pharmacological actions. Technologies employed include those concerning drug preparation, route of administration, site targeting, metabolism, and toxicity.
Genetic mechanisms that allow GENES to be expressed at a similar level irrespective of their GENE DOSAGE. This term is usually used in discussing genes that lie on the SEX CHROMOSOMES. Because the sex chromosomes are only partially homologous, there is a different copy number, i.e., dosage, of these genes in males vs. females. In DROSOPHILA, dosage compensation is accomplished by hypertranscription of genes located on the X CHROMOSOME. In mammals, dosage compensation of X chromosome genes is accomplished by random X CHROMOSOME INACTIVATION of one of the two X chromosomes in the female.
Concentration or quantity that is derived from the smallest measure that can be detected with reasonable certainty for a given analytical procedure.
Dynamic and kinetic mechanisms of exogenous chemical and DRUG LIBERATION; ABSORPTION; BIOLOGICAL TRANSPORT; TISSUE DISTRIBUTION; BIOTRANSFORMATION; elimination; and DRUG TOXICITY as a function of dosage, and rate of METABOLISM. LADMER, ADME and ADMET are abbreviations for liberation, absorption, distribution, metabolism, elimination, and toxicology.
Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output.
A beta-adrenergic antagonist used in the treatment of hypertension, angina pectoris, arrhythmias, and anxiety.
Determination of the spectra of ultraviolet absorption by specific molecules in gases or liquids, for example Cl2, SO2, NO2, CS2, ozone, mercury vapor, and various unsaturated compounds. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
Poly-2-methylpropenoic acids. Used in the manufacture of methacrylate resins and plastics in the form of pellets and granules, as absorbent for biological materials and as filters; also as biological membranes and as hydrogens. Synonyms: methylacrylate polymer; poly(methylacrylate); acrylic acid methyl ester polymer.
Colloids formed by the combination of two immiscible liquids such as oil and water. Lipid-in-water emulsions are usually liquid, like milk or lotion. Water-in-lipid emulsions tend to be creams. The formation of emulsions may be aided by amphiphatic molecules that surround one component of the system to form MICELLES.
A tricyclic antidepressant with some tranquilizing action.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
Relating to the size of solids.
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
The process of keeping pharmaceutical products in an appropriate location.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
Agents which are destructive to amebae, especially the parasitic species causing AMEBIASIS in man and animal.
A measure of the amount of WATER VAPOR in the air.
Technique whereby the weight of a sample can be followed over a period of time while its temperature is being changed (usually increased at a constant rate).
A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.
An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.
The study of the physical and chemical properties of a drug and its dosage form as related to the onset, duration, and intensity of its action.
A cellulose derivative which is a beta-(1,4)-D-glucopyranose polymer. It is used as a bulk laxative and as an emulsifier and thickener in cosmetics and pharmaceuticals and as a stabilizer for reagents.
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.
A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
The mechanical property of material that determines its resistance to force. HARDNESS TESTS measure this property.
Drugs used by veterinarians in the treatment of animal diseases. The veterinarian's pharmacological armamentarium is the counterpart of drugs treating human diseases, with dosage and administration adjusted to the size, weight, disease, and idiosyncrasies of the species. In the United States most drugs are subject to federal regulations with special reference to the safety of drugs and residues in edible animal products.
Differential thermal analysis in which the sample compartment of the apparatus is a differential calorimeter, allowing an exact measure of the heat of transition independent of the specific heat, thermal conductivity, and other variables of the sample.
Term used to designate tetrahydroxy aldehydic acids obtained by oxidation of hexose sugars, i.e. glucuronic acid, galacturonic acid, etc. Historically, the name hexuronic acid was originally given to ascorbic acid.
A triglyceride that is used as an antifungal agent.
The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH = log 1/2[1/(H+)], where (H+) is the hydrogen ion concentration in gram equivalents per liter of solution. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)
A sugar acid formed by the oxidation of the C-6 carbon of GLUCOSE. In addition to being a key intermediate metabolite of the uronic acid pathway, glucuronic acid also plays a role in the detoxification of certain drugs and toxins by conjugating with them to form GLUCURONIDES.
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
The various ways of administering a drug or other chemical to a site in a patient or animal from where the chemical is absorbed into the blood and delivered to the target tissue.
A polysaccharide with glucose units linked as in CELLOBIOSE. It is the chief constituent of plant fibers, cotton being the purest natural form of the substance. As a raw material, it forms the basis for many derivatives used in chromatography, ion exchange materials, explosives manufacturing, and pharmaceutical preparations.
A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
Cyclic GLUCANS consisting of seven (7) glucopyranose units linked by 1,4-glycosidic bonds.
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions.They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects.
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
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)
The time it takes for a substance (drug, radioactive nuclide, or other) to lose half of its pharmacologic, physiologic, or radiologic activity.
Theoretical representations that simulate the behavior or activity of biological processes or diseases. For disease models in living animals, DISEASE MODELS, ANIMAL is available. Biological models include the use of mathematical equations, computers, and other electronic equipment.
Elements of limited time intervals, contributing to particular results or situations.
Salts or ions of the theoretical carbonic acid, containing the radical CO2(3-). Carbonates are readily decomposed by acids. The carbonates of the alkali metals are water-soluble; all others are insoluble. (From Grant & Hackh's Chemical Dictionary, 5th ed)
A nonionic polyoxyethylene-polyoxypropylene block co-polymer with the general formula HO(C2H4O)a(-C3H6O)b(C2H4O)aH. It is available in different grades which vary from liquids to solids. It is used as an emulsifying agent, solubilizing agent, surfactant, and wetting agent for antibiotics. Poloxamer is also used in ointment and suppository bases and as a tablet binder or coater. (Martindale The Extra Pharmacopoeia, 31st ed)
Descriptions of specific amino acid, carbohydrate, or nucleotide sequences which have appeared in the published literature and/or are deposited in and maintained by databanks such as GENBANK, European Molecular Biology Laboratory (EMBL), National Biomedical Research Foundation (NBRF), or other sequence repositories.
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
The rate dynamics in chemical or physical systems.
Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications.
The process of cumulative change at the level of DNA; RNA; and PROTEINS, over successive generations.
The physical or physiological processes by which substances, tissue, cells, etc. take up or take in other substances or energy.
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.
The presence of organisms, or any foreign material that makes a drug preparation impure.
Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS).
Uptake of substances through the lining of the INTESTINES.
Salts of alginic acid that are extracted from marine kelp and used to make dental impressions and as absorbent material for surgical dressings.
Small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers.
The molecular designing of drugs for specific purposes (such as DNA-binding, enzyme inhibition, anti-cancer efficacy, etc.) based on knowledge of molecular properties such as activity of functional groups, molecular geometry, and electronic structure, and also on information cataloged on analogous molecules. Drug design is generally computer-assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.
Substances used for the detection, identification, analysis, etc. of chemical, biological, or pathologic processes or conditions. Indicators are substances that change in physical appearance, e.g., color, at or approaching the endpoint of a chemical titration, e.g., on the passage between acidity and alkalinity. Reagents are substances used for the detection or determination of another substance by chemical or microscopical means, especially analysis. Types of reagents are precipitants, solvents, oxidizers, reducers, fluxes, and colorimetric reagents. (From Grant & Hackh's Chemical Dictionary, 5th ed, p301, p499)
Deacetylated CHITIN, a linear polysaccharide of deacetylated beta-1,4-D-glucosamine. It is used in HYDROGEL and to treat WOUNDS.
The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms.
Removal of moisture from a substance (chemical, food, tissue, etc.).
A property of the surface of an object that makes it stick to another surface.
The relationship between the dose of an administered drug and the response of the organism to the drug.
A product formed from skin, white connective tissue, or bone COLLAGEN. It is used as a protein food adjuvant, plasma substitute, hemostatic, suspending agent in pharmaceutical preparations, and in the manufacturing of capsules and suppositories.
Compounds based on a partially saturated iminoethanophenanthrene, which can be described as ethylimino-bridged benzo-decahydronaphthalenes. They include some of the OPIOIDS found in PAPAVER that are used as ANALGESICS.
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)
Microscopy in which the object is examined directly by an electron beam scanning the specimen point-by-point. The image is constructed by detecting the products of specimen interactions that are projected above the plane of the sample, such as backscattered electrons. Although SCANNING TRANSMISSION ELECTRON MICROSCOPY also scans the specimen point by point with the electron beam, the image is constructed by detecting the electrons, or their interaction products that are transmitted through the sample plane, so that is a form of TRANSMISSION ELECTRON MICROSCOPY.
A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.
Method of tissue preparation in which the tissue specimen is frozen and then dehydrated at low temperature in a high vacuum. This method is also used for dehydrating pharmaceutical and food products.
Any detectable and heritable change in the genetic material that causes a change in the GENOTYPE and which is transmitted to daughter cells and to succeeding generations.
The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example.
Authoritative treatises on drugs and preparations, their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc. They are usually published under governmental jurisdiction (e.g., USP, the United States Pharmacopoeia; BP, British Pharmacopoeia; P. Helv., the Swiss Pharmacopoeia). They differ from FORMULARIES in that they are far more complete: formularies tend to be mere listings of formulas and prescriptions.
A statistical means of summarizing information from a series of measurements on one individual. It is frequently used in clinical pharmacology where the AUC from serum levels can be interpreted as the total uptake of whatever has been administered. As a plot of the concentration of a drug against time, after a single dose of medicine, producing a standard shape curve, it is a means of comparing the bioavailability of the same drug made by different companies. (From Winslade, Dictionary of Clinical Research, 1992)
Uptake of substances through the SKIN.
Statistical models in which the value of a parameter for a given value of a factor is assumed to be equal to a + bx, where a and b are constants. The models predict a linear regression.
Nanometer-sized particles that are nanoscale in three dimensions. They include nanocrystaline materials; NANOCAPSULES; METAL NANOPARTICLES; DENDRIMERS, and QUANTUM DOTS. The uses of nanoparticles include DRUG DELIVERY SYSTEMS and cancer targeting and imaging.
The analysis of a chemical substance by inserting a sample into a carrier stream of reagent using a sample injection valve that propels the sample downstream where mixing occurs in a coiled tube, then passes into a flow-through detector and a recorder or other data handling device.
A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS.
A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
The sequence of PURINES and PYRIMIDINES in nucleic acids and polynucleotides. It is also called nucleotide sequence.
Theoretical representations that simulate the behavior or activity of chemical processes or phenomena; includes the use of mathematical equations, computers, and other electronic equipment.
Those persons legally qualified by education and training to engage in the practice of pharmacy.
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)
Colloids with a solid continuous phase and liquid as the dispersed phase; gels may be unstable when, due to temperature or other cause, the solid phase liquefies; the resulting colloid is called a sol.
Condition of having pores or open spaces. This often refers to bones, bone implants, or bone cements, but can refer to the porous state of any solid substance.
The resistance that a gaseous or liquid system offers to flow when it is subjected to shear stress. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)
Differential and non-random reproduction of different genotypes, operating to alter the gene frequencies within a population.
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.
Liquids that dissolve other substances (solutes), generally solids, without any change in chemical composition, as, water containing sugar. (Grant & Hackh's Chemical Dictionary, 5th ed)
A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
The order of amino acids as they occur in a polypeptide chain. This is referred to as the primary structure of proteins. It is of fundamental importance in determining PROTEIN CONFORMATION.
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
A biocompatible polymer used as a surgical suture material.
Generally refers to the digestive structures stretching from the MOUTH to ANUS, but does not include the accessory glandular organs (LIVER; BILIARY TRACT; PANCREAS).
A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.
The female sex chromosome, being the differential sex chromosome carried by half the male gametes and all female gametes in human and other male-heterogametic species.
The action of a drug that may affect the activity, metabolism, or toxicity of another drug.
... manufactured and/or marketed generic versions of antacid Zantac and antidepressant Prozac in dosage forms that weren't subject ... for generic drugs. The lawsuit alleges drugstore chain Walgreen and generic pharmaceutical maker Par established a partnership ... a generic form of Zantac and fluoxetine, which is a generic form of Prozac." In 2009 Walgreens threatened to leave the Medicaid ... It further said Walgreen purchased those dosage forms from Par at a cost substantially higher than the widely prescribed dosage ...
Pharmaceutical dextroamphetamine sulfate is available as both a brand name and generic drug in a variety of dosage forms. ... The percent of the drug hydroxylated to hydroxynorephedrine was comparable in all subjects (6.5-9.62) (Table 3). Freeman JJ, ... "Drugs@FDA: FDA Approved Drug Products: Dexedrine". U.S. Food and Drug Administration. Retrieved 30 December 2015. DEXEDRINE ... DOSAGE FORMS AND STRENGTHS Extended-release oral suspension contains 2.5 mg amphetamine base equivalents per mL. Cite error: ...
This landmark Supreme Court case was instrumental in the development of Canada's generic drug industry. Louis Winter soon had ... of these products could be synthesized or purchased in bulk and then manufactured or packaged into their required dosage forms ... and graduated with a master's degree in the subject. In 1948 he borrowed $10,000 from his father Abraham, and opened his first ... Louis Lloyd Winter (March 17, 1924-November 5, 1965) was a Canadian entrepreneur and one of the pioneers of Canada's generic ...
Alternative dosage forms have been developed in an effort to reduce blood levels of N-desethyloxybutynin and achieve a steadier ... It is available as a generic medication. In 2018, it was the 102nd most commonly prescribed medication in the United States, ... N-Desethyloxybutynin plasma levels may reach as much as six times that of the parent drug after administration of the immediate ... bypasses the first-pass hepatic effect that the oral formulations are subject to. In those with overflow incontinence because ...
Veterinary dosage forms include 25 mg, 75 mg, and 100 mg tablets, and 50 mg per mL injectable form. International ... "Effect of non-steroidal anti-inflammatory drugs on postoperative respiratory and heart rate in cats subjected to ... "Generic Dog Rimadyl Online". Archived from the original on 2011-07-15. Retrieved 2011-07-15. Boström IM, Nyman GC, Lord PE, ... The drug was taken orally. Pfizer voluntarily removed it from the market for human use on commercial grounds. Carprofen may be ...
Generic drug Pharmacokinetics Clinical trial Abbreviated New Drug Application Birkett DJ (2003). "Generics - equal or not?" ( ... Pharmaceutical equivalence implies the same amount of the same active substance(s), in the same dosage form, for the same route ... studies are conducted whereby each of the preparations are administered in a cross-over study to volunteer subjects, generally ... FDA CDER Office of Generic Drugs - further U.S. information on bioequivalence testing and generic drugs Proposal to waive in ...
"Branded generics" on the other hand are defined by the FDA and NHS as "products that are (a) either novel dosage forms of off- ... Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in ... Definition of generic drug *^ "Food & Drug Administration, Generic Drugs: Questions and Answers". Food and Drug Administration ... "Facts about Generic Drugs". Food and Drug Administration.. *^ Davit; et al. (2009). "Comparing generic and innovator drugs: a ...
"Branded generics" on the other hand are defined by the FDA and NHS as "products that are (a) either novel dosage forms of off- ... and they are subject to extra rules. When an application is approved, the FDA adds the generic drug to its Approved Drug ... generic drug naming process, lists of adopted names USFDA, Office of Generic Drugs UK Department of Health, generic drugs The ... "FAQ on generic drugs". FDA. Food and drug administration. Retrieved 21 May 2018. "FDA White Paper: Generic Drug Prices in the ...
The drug was the subject of a scathing and highly critical article by The Washington Post in November 2006. CDMA was ... that the conversion is far from complete and that much of the activity of the drug may be attributable to its unchanged form. ... in the United States.CDMA continued to be sold online until the 2014 prohormone ban as generic versions known as clones. ... poses no risk of estrogenic side effects like gynecomastia at any dosage. It is not extensively metabolized by 5α-reductase and ...
SPLIMAGE is for image files of oral solid dosage forms that are submitted to the Food and Drug Administration (FDA) with SPL ... Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, ... Participants come from: Industry sponsors of human and veterinary (pharmaceuticals, generic pharmaceuticals, biologics, devices ... Drug Establishment Registration and Drug Listing (PDF) (Report). Food and Drug Administration. Retrieved 2015-07-18. Kass-Hout ...
"Concerta (Methylphenidate Extended-Release Tablets) Drug Information: User Reviews, Side Effects, Drug Interactions and Dosage ... Generic forms are produced by numerous pharmaceutical companies throughout the world. Methylphenidate is available in numerous ... "Ethylphenidate formation in human subjects after the administration of a single dose of methylphenidate and ethanol". Drug ... An alternative to Ritalin‑SR from Novartis "Drugs@FDA: FDA Approved Drug Products". Drugs@FDA: FDA Approved Drug Products. US ...
Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route ... dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This Act has ... When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being ... new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, ...
... than proprietary drugs (23%), and price hikes for generic drugs cannot be passed onto states, and a common form of ... The reason stated by Sanofi was that the products had been found to potentially have inaccurate dosage delivery, which may ... "Canadians users of EpiPen not subject to price hike as U.S. consumers". Aug 26, 2016. Retrieved 6 September 2016. Carly Helfand ... In the case of Intelliject, it is the generic drug in a new device. For an explanation see Kenneth V. Phelps for Drug Discovery ...
This marked the start of the FDA approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to ... the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic ... dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has ... "generic" name of a drug along with the trade name, the restriction of drug advertising to FDA-approved indications, and ...
It is available as a generic and brand-name product. Lactulose is made from the milk sugar lactose, which is composed of two ... The dosage of lactulose for chronic idiopathic constipation is adjusted depending on the constipation severity and desired ... An alternate explanation for differences in results is the variance in small bowel transit time among tested subjects. No ... It is a disaccharide formed from one molecule each of the simple sugars (monosaccharides) fructose and galactose. Lactulose is ...
... and that it would license the drug to generics manufacturers for sale in the developing world. As of January 2016, a twelve- ... Daclatasvir reaches steady state in human subjects after about 4 days of once-daily 60 mg oral administration, with a peak dose ... It comes in the form of an oral tablet, with a bioavailability of 67%. Daclatasvir is predominantly metabolized by the liver ... Currently, there are no required dosage adjustments with concurrent use of daclatasvir and immunosuppressants, narcotic ...
... than proprietary drugs (23%), and price hikes for generic drugs cannot be passed onto states, and a common form of ... "Updated: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery". ... "Canadians users of EpiPen not subject to price hike as U.S. consumers". Aug 26, 2016. Retrieved 6 September 2016.. ... In the case of Intelliject, it is the generic drug in a new device. For an explanation see Kenneth V. Phelps for Drug Discovery ...
... dosage form and route of administration) and has been shown to have comparable bioavailability. These characteristics allowed ... "Drug Approval Package: Bonsity". U.S. Food and Drug Administration (FDA). 26 February 2020. Retrieved 14 September 2020. Pfenex ... A synthetic teriparatide from Teva Generics has been authorised for marketing in the European Union. Biosimilar product from ... it was found to potentially be associated with developing osteosarcoma in test subjects after over 2 years of use. Patients ...
However, the generic is not available in the same dosages as branded Viagra, so using dosages typically required for treating ... As of 2018, the U.S. Food and Drug Administration has approved fifteen drug manufacturers to market generic sildenafil in the ... Generic versions of this low-dose form of sildenafil have been available in the U.S. from a number of manufacturers, including ... While the sale remains subject to a consultation with a pharmacist, the other restrictions from the trial have been removed, ...
In 2001 Reddy's became the first Indian company to launch the generic drug, fluoxetine (a generic version of Eli Lilly and ... Barr Laboratories of the U.S. obtained exclusivity for all of the approved dosage forms (10 mg, 20 mg) except one (40 mg), ... Reddy's has a license from Merck, it was not subject to the exclusivity period on generic simvastatin. As of 2006, Dr. Reddy's ... to sell an authorized generic version of the popular drug simvastatin (Zocor) in the USA. Since Dr. ...
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Armstrong, N.A.; James, K.C. (1980). "Drug release from lipid-based dosage forms. I". International Journal of Pharmaceutics. 6 ... Estradiol undecylate is the generic name of the drug and its INN and USAN. It is also spelled in some publications as estradiol ... Subject characteristics and assay method were not described. Source was Vermeulen (1975). Estradiol levels after a short ... It has been used at a dosage of 100 mg every 3 to 4 weeks (or once a month) by intramuscular injection for this indication. ...
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  • The Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as "Hatch-Waxman") and amendments such as the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, granted companies manufacturing generic chemical pharmaceuticals the option of filing an abbreviated new drug application (ANDA) - a far less complex application than the NDA required for pioneer chemical drug manufacturers. (
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  • Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company's control. (
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  • On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) , which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. (
  • More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page. (
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  • Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B). (
  • Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d). (
  • The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies. (
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  • In order to do this, GDUFA enables the FDA to collect user fees that are used to support critical and measurable enhancements to FDA's generic drug program. (
  • This web page only describes FDA's plans for issuing new and revised PSGs for these complex generic drug products. (
  • While this list reflects FDA's effort to be transparent regarding current plans for developing PSGs for complex generic drug products, it should be noted that timing may be subject to change. (
  • GDUFA aims to put FDA's generic drug program on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs. (
  • GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA's generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. (
  • The draft discusses FDA's interpretation of the statutory phrase "bulk drug substances for which there is a clinical need," which the agency says means that there is a clinical need for an outsourcing facility to compound a drug and that the drug must be compounded using a particular bulk drug substance. (
  • By establishing in the ANDA that the generic chemical pharmaceutical drug product is the same as the approved innovator drug, the applicant can rely on the FDA's findings of safety and effectiveness for the brand-name drug. (
  • company focused on developing and manufacturing difficult to develop, technology-driven specialty generics for the US markets. (
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  • This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. (
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  • For the 30 drugs that act on the circulatory system, we examined each in terms of subject selection (healthy volunteers vs. patients), dosage strength, dosage route, analytes to measure, and evaluation parameters, and prepared bioequivalence recommendations for individual products through an analysis of many published papers, US FDA and EMEA guidelines, and clinical trial websites. (
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  • The individual bioequivalence recommendations have been used by KFDA officers in drug evaluations and bioequivalency testing to improve consistency, clarity, and professionalism in the drug evaluation process. (
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  • Licensing authorities in the respective countries of manufacture are expected to be responsible for the review and approval of the detailed composition and formulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted by the manufacturer of the dosage form, and to oversee compliance with GMP requirements as recommended by WHO. (
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  • The f2 factor was incorporated as an assessment criterion in the design of an artificial neural network that was used to predict drug release profiles and formulation composition. (
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  • Side effects can be either beneficial or harmful, whereas adverse events are always harmful, with undesired complications secondary to the intended effect of the drug. (
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  • Adverse Reactions Occurring at an Incidence of 2 or More generic Amo ng seroquel Treated Patients in Short-Term, Placebo-Controlled Trials The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the. (
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  • Pharmacokinetic studies are conducted whereby each of the drugs is administered in a cross over study to healthy volunteer's subjects. (
  • The crossover design may not be practical for drugs with long pharmacokinetic half-lives ( i.e. , longer than 24 hours). (
  • Ask frontline nurses, pharmacists, technicians, unit secretaries, and physicians to view the samples of the written product name as well as pronounce it to determine if it looks or sounds like any other drug product or medical term. (
  • The FDA considers a compounded product to be an adulterated, ie, unapproved, new animal drug and thus a violation. (
  • registration status of the product in the country of origin · information on production capacity and lead times · indicative prices in the country of origin · whether the manufacturer is in possession of a manufacturing licence and a certificate of good manufacturing practices (GMP) * issued by the National Drug Regulatory Authority. (
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  • A must attend seminar for anyone involved in product developments and assessments of solid oral dosage forms! (
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  • What is a complex generic drug product? (
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  • A sustained-release dosage form containing CBZ is currently marketed as Tegretol® CR and the development of a generic product would provide patients with an equivalent product with a similar dosing frequency, at a reduced cost. (
  • Stability testing was conducted to assess the behaviour of the dosage forms under storage conditions that the product may be exposed to. (
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  • This is a listing of current drug shortages, including drug product name and reason for shortage. (
  • This generic cancdian of treating online care works best in product improving your sculpture making approval. (
  • First Generic Product Received? (
  • This change may incentivize multinational companies wishing to bring innovative drugs to China to start their product development in China earlier in the process than before in order to realize marketing advantages. (
  • For domestic companies to market a generic drug, they are now required to demonstrate the equivalent quality and efficacy against the originator's product, regardless of whether the originator's drug is marketed in China. (
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  • The manufacturer must make one of four certifications about patents covering its product, the most important for present purposes being a "paragraph IV" certification that the patents for the branded drug are invalid or will not be infringed by the generic drug. (
  • If the generic prevails in subsequent litigation, and was the first to have filed an ANDA referencing the branded product and containing a paragraph IV certification, it is eligible to obtain a 180-day period of exclusivity, during which no other generic approved via the ANDA process may be sold. (
  • Absent a contrary agreement, the NDA holder is free during this 180-day period to market an "authorized generic" ("AG") generally, an AB-rated version of the branded product ( i.e. , one subject to generic substitution) that is manufactured by or under license from the NDA holder. (
  • For most products, the focus of BE studies is on the release of the drug substance from the drug product into the systemic circulation. (
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  • The New Classification further defines the originator's drug as the drug that was first approved in the world, supported with complete and sufficient safety and efficacy data for marketing approval. (
  • 4. Category IV: Generic drugs, with equivalent quality and efficacy to the originator's drugs, that are already marketed in China. (
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  • With name pairs known to be problematic, reduce the potential for confusion by writing prescriptions using both the brand and generic name. (
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  • generic 969) and 841 on venlafaxine (brand 370 and generic 471). (
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  • No-AG agreements are components of Hatch-Waxman patent infringement litigation settlements in which the brand manufacturer agrees, expressly or through exclusive licenses, not to launch an "Authorized Generic" for a period of time after the generic manufacturer's entry. (
  • Also, can follow-on drugs be more affordable while still having the same bioequivalency as brand-name drugs? (
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  • From Days 3 - 14 and 21 - 35, subjects will receive an oral 400 mg dose of Tazemetostat twice daily (12 hours apart). (
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  • This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. (
  • To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. (
  • This advance notice will help generic drug companies to plan for their development of complex generic drug products. (
  • About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. (
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  • Flexibility in dosage form design and development ii. (
  • Because of the importance of dosage form in drug development and consumption, it is crucial to provide accurate dosage form information in drug-related information resources. (
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  • In addition to this information, the list of PSGs for complex generic products under revision also includes the planned revision categories. (
  • Below is the list of PSGs for complex generic drug products that FDA plans to issue and the list of PSGs that FDA plans to revise in the coming year. (
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  • Today's arguments over follow-on biologics seem to mirror to a large degree those surrounding Hatch-Waxman and chemical drugs 20 years ago: What is the proper balance between allowing cheaper access to products while still protecting the owner's intellectual property? (
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  • Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only). (
  • What is the generic drug applicant program fee? (
  • GDUFA II includes a Generic Drug Applicant Program Fee, which is assessed annually. (
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