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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