Book Details

Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond / Umesh V. Banakar

Publication year: 2022

ISBN: 1119634601

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Delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety. A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products


Subject: Pharmacology, Pharmaceutics, Drugs Solubility Testing, Médicaments Solubilité Essais, Bioavailability, Bioequivalence, Biosimilars, Pharmaceutical chemistry, Medicinal Chemistry, Drug Discovery, Drug Development, Pharmaceutical Dosage