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Bioequivalence

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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Drugs --- Therapeutic equivalency. --- Standards --- Bioequivalence in drugs --- Clinical equivalence in drugs --- Therapeutic equivalency in drugs --- Biopharmaceutics --- Equivalency, Therapeutic --- Pharmaceutical technology. --- Pharmaceutical Sciences/Technology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- United States. --- FDA --- F.D.A. --- U.S. Food & Drug Administration

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This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modeling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.   Vinod P. Shah is a pharmaceutical consultant. He was Scientific Secretary of the International Pharmaceutical Federation (FIP) and is now Chair of the FIP Regulatory Sciences Special Interest Group. Dr. Shah has served at the U.S. Food and Drug Administration and has developed several regulatory guidances for the pharmaceutical industry in biopharmaceutics and topical drug products. Howard I. Maibach is professor of dermatology at the University of California, San Francisco. He received his M.D. at Tulane University Medical School in New Orleans, Louisiana, and completed his residency and research fellowships at the University of Pennsylvania in Philadelphia, Pennsylvania. Professor Maibach is a leading authority in the fields of dermatotoxicology and dermatopharmacology, in which he has conducted research and written extensively. John Jenner is a principal scientist at The Defence Science and Technology Laboratory in the UK. He has a degree in pharmacology from the University of Manchester in Manchester, UK, and a Ph.D. from the University of Surrey, Guildford, UK. John has spent his career studying defense against and treatment of highly toxic chemicals. He has an enduring research interest in percutaneously active chemicals, whether toxic materials or drugs, and experience in the design and testing of transdermal formulations.

Therapeutics, Cutaneous and external. --- Bioavailability. --- Drugs --- Skin --- Therapeutic equivalency. --- Permeability. --- Cutaneous permeability --- Skin permeability --- Bioequivalence in drugs --- Clinical equivalence in drugs --- Therapeutic equivalency in drugs --- Biopharmaceutics --- Availability, Biological --- Biological availability --- Physiologic availability --- Physiological availability --- Biochemistry --- Cutaneous therapeutics --- Equivalency, Therapeutic --- Toxicology. --- Animal physiology. --- Pharmacology/Toxicology. --- Animal Physiology. --- Biological and Medical Physics, Biophysics. --- Animal physiology --- Animals --- Biology --- Anatomy --- Chemicals --- Medicine --- Pharmacology --- Poisoning --- Poisons --- Physiology --- Toxicology --- Pharmacology. --- Biophysics. --- Biological physics. --- Biological physics --- Medical sciences --- Physics --- Drug effects --- Medical pharmacology --- Chemotherapy --- Pharmacy --- Physiological effect

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The gastrointestinal tract (GIT) can be broadly divided into several regions: the stomach, the small intestine (which is subdivided to duodenum, jejunum, and ileum), and the colon. The conditions and environment in each of these segments, and even within the segment, are dependent on many factors, e.g., the surrounding pH, fluid composition, transporters expression, metabolic enzymes activity, tight junction resistance, different morphology along the GIT, variable intestinal mucosal cell differentiation, changes in drug concentration (in cases of carrier-mediated transport), thickness and types of mucus, and resident microflora. Each of these variables, alone or in combination with others, can fundamentally alter the solubility/dissolution, the intestinal permeability, and the overall absorption of various drugs. This is the underlying mechanistic basis of regional-dependent intestinal drug absorption, which has led to many attempts to deliver drugs to specific regions throughout the GIT, aiming to optimize drug absorption, bioavailability, pharmacokinetics, and/or pharmacodynamics. In the book "Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation" we aim to highlight the current progress and to provide an overview of the latest developments in the field of regional-dependent intestinal drug absorption and delivery, as well as pointing out the unmet needs of the field.

Medicine --- Pharmaceutical industries --- bioequivalence --- Biopharmaceutics Classification System --- in vitro --- dissolution test --- pravastatin --- oral absorption --- in silico modeling --- GastroPlus --- Phoenix WinNonlin --- pharmacokinetics --- clinical studies --- ibuprofen --- manometry --- gastrointestinal --- mechanistic modeling --- PBPK --- PBBM --- disintegration --- dissolution --- enteric-coated --- ICH --- quality control --- regional intestinal permeability --- permeation enhancers --- absorption-modifying excipients --- oral peptide delivery --- intestinal perfusion --- pharmaceutical development --- controlled release drug product --- biopharmaceutics classification system --- drug solubility --- drug permeability --- location-dependent absorption --- segregated flow intestinal model (SFM) --- traditional model (TM) --- route-dependent intestinal metabolism --- first-pass effect --- drug-drug interactions --- DDI --- in vitro in vivo extrapolations --- IVIVE --- zero-order absorption --- first-order absorption --- combined zero- and first-order absorption --- transit compartment absorption model --- in situ perfusion --- microdevices --- shape --- mucoadhesion --- colon absorption --- nutrient digestion --- nutrient absorption --- gastrointestinal hormone --- postprandial glycaemia --- energy intake --- region of the gut --- obesity --- type 2 diabetes --- Franz–PAMPA --- BCS drugs --- biomimetic membrane --- Franz cell --- passive drug transport --- BCS class IV drugs --- segmental-dependent intestinal permeability --- intestinal absorption --- oral drug delivery --- biopharmaceutics --- physiologically-based pharmacokinetic (PBPK) modeling --- furosemide --- intestinal permeability --- human colon carcinoma cell layer (Caco-2) --- hierarchical support vector regression (HSVR) --- drug absorption --- drug solubility/dissolution --- regional/segmental-dependent permeability and absorption --- bioequivalence --- Biopharmaceutics Classification System --- in vitro --- dissolution test --- pravastatin --- oral absorption --- in silico modeling --- GastroPlus --- Phoenix WinNonlin --- pharmacokinetics --- clinical studies --- ibuprofen --- manometry --- gastrointestinal --- mechanistic modeling --- PBPK --- PBBM --- disintegration --- dissolution --- enteric-coated --- ICH --- quality control --- regional intestinal permeability --- permeation enhancers --- absorption-modifying excipients --- oral peptide delivery --- intestinal perfusion --- pharmaceutical development --- controlled release drug product --- biopharmaceutics classification system --- drug solubility --- drug permeability --- location-dependent absorption --- segregated flow intestinal model (SFM) --- traditional model (TM) --- route-dependent intestinal metabolism --- first-pass effect --- drug-drug interactions --- DDI --- in vitro in vivo extrapolations --- IVIVE --- zero-order absorption --- first-order absorption --- combined zero- and first-order absorption --- transit compartment absorption model --- in situ perfusion --- microdevices --- shape --- mucoadhesion --- colon absorption --- nutrient digestion --- nutrient absorption --- gastrointestinal hormone --- postprandial glycaemia --- energy intake --- region of the gut --- obesity --- type 2 diabetes --- Franz–PAMPA --- BCS drugs --- biomimetic membrane --- Franz cell --- passive drug transport --- BCS class IV drugs --- segmental-dependent intestinal permeability --- intestinal absorption --- oral drug delivery --- biopharmaceutics --- physiologically-based pharmacokinetic (PBPK) modeling --- furosemide --- intestinal permeability --- human colon carcinoma cell layer (Caco-2) --- hierarchical support vector regression (HSVR) --- drug absorption --- drug solubility/dissolution --- regional/segmental-dependent permeability and absorption

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The gastrointestinal tract (GIT) can be broadly divided into several regions: the stomach, the small intestine (which is subdivided to duodenum, jejunum, and ileum), and the colon. The conditions and environment in each of these segments, and even within the segment, are dependent on many factors, e.g., the surrounding pH, fluid composition, transporters expression, metabolic enzymes activity, tight junction resistance, different morphology along the GIT, variable intestinal mucosal cell differentiation, changes in drug concentration (in cases of carrier-mediated transport), thickness and types of mucus, and resident microflora. Each of these variables, alone or in combination with others, can fundamentally alter the solubility/dissolution, the intestinal permeability, and the overall absorption of various drugs. This is the underlying mechanistic basis of regional-dependent intestinal drug absorption, which has led to many attempts to deliver drugs to specific regions throughout the GIT, aiming to optimize drug absorption, bioavailability, pharmacokinetics, and/or pharmacodynamics. In the book "Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation" we aim to highlight the current progress and to provide an overview of the latest developments in the field of regional-dependent intestinal drug absorption and delivery, as well as pointing out the unmet needs of the field.

bioequivalence --- Biopharmaceutics Classification System --- in vitro --- dissolution test --- pravastatin --- oral absorption --- in silico modeling --- GastroPlus --- Phoenix WinNonlin --- pharmacokinetics --- clinical studies --- ibuprofen --- manometry --- gastrointestinal --- mechanistic modeling --- PBPK --- PBBM --- disintegration --- dissolution --- enteric-coated --- ICH --- quality control --- regional intestinal permeability --- permeation enhancers --- absorption-modifying excipients --- oral peptide delivery --- intestinal perfusion --- pharmaceutical development --- controlled release drug product --- biopharmaceutics classification system --- drug solubility --- drug permeability --- location-dependent absorption --- segregated flow intestinal model (SFM) --- traditional model (TM) --- route-dependent intestinal metabolism --- first-pass effect --- drug-drug interactions --- DDI --- in vitro in vivo extrapolations --- IVIVE --- zero-order absorption --- first-order absorption --- combined zero- and first-order absorption --- transit compartment absorption model --- in situ perfusion --- microdevices --- shape --- mucoadhesion --- colon absorption --- nutrient digestion --- nutrient absorption --- gastrointestinal hormone --- postprandial glycaemia --- energy intake --- region of the gut --- obesity --- type 2 diabetes --- Franz–PAMPA --- BCS drugs --- biomimetic membrane --- Franz cell --- passive drug transport --- BCS class IV drugs --- segmental-dependent intestinal permeability --- intestinal absorption --- oral drug delivery --- biopharmaceutics --- physiologically-based pharmacokinetic (PBPK) modeling --- furosemide --- intestinal permeability --- human colon carcinoma cell layer (Caco-2) --- hierarchical support vector regression (HSVR) --- drug absorption --- drug solubility/dissolution --- regional/segmental-dependent permeability and absorption