Biopharmaceutics Applications in Drug Development

ISBN-13: 9781441944344 / Angielski / Miękka / 2010 / 396 str.

Rajesh Krishna; Lawrence Yu

Opis

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.

Recenzje

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)

Spis treści

to Biopharmaceutics and its Role in Drug Development.- Molecular and Physicochemical Properties Impacting OralAbsorptionofDrugs.- Dissolution Testing.- Drug Absorption Principles.- Evaluation of Permeability and P-glycoprotein Interactions: Industry Outlook.- Excipients as Absorption Enhancers.- IntestinalTransporters in Drug Absorption.- Bioavailability and Bioequivalence.- A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies.- Food Effects on Drug Bioavailability: Implications for New and Generic Drug Development.- In Vitro–In Vivo Correlation on Parenteral Dosage Forms.- In Vitro–In Vivo Correlation in Dosage Form Development: Case Studies.

Blurb

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.