Biopharmaceutics Applications in Drug Development
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Beschreibung
In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.
Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Drug performance is a vital aspect of new drug development as it draws on interdisciplinary expertise from both pharmaceutics and pharmacokinetics disciplines. It is at the key interface that the discipline of biopharmaceutics has emerged. The past two decades have witnessed considerable advances in biopharmaceutics, particularly with regard to bioavailability/bioequivalence, product quality and regulatory standards of approval.
Biopharmaceutics Applications in Drug Development presents readers with step-wise, detail-conscious information to develop quality pharmaceuticals. It is composed of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality, with specific focus on integration of regulatory considerations and case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.
discusses state of the art knowledge in biopharmaceutics identifies key issues and opportunities in a distinct problem-solving approach
Autor*in
Rajesh Krishna
Themen in »Biopharmaceutics Applications in Drug Development«
absorption bioequivalence biomedicine biopharmaceuticals drug drug development kinetics pharmacokinetics protein
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From the reviews:
"The objective of this book is to present ‘an integrated view linking pharmaceutics and the biological consequences to drug development decision making.’ It is written primarily for those who work in the pharmaceutical industry applying biopharmaceutics and pharmacokinetics, or interacting with formulation scientists. The book will also be useful for those in academic and research environments. It could be valuable for students of biopharmaceutics in undergraduate or graduate programs in pharmaceutical science, and should find a role as an innovative pharmD curriculum elective." (Joseph Boullata, Doody’s Review Service, August, 2008)
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