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Pharmacokinetics: Regulatory-industrial-academic perspectives
ELSEVIER
Pharmacokinetics: Regulatory-Industrial-Academic Perspectives, 2nd Ed., by Peter G. Welling and Francis L. S. Tse, Marcel Dekker, Inc., New York, 1995, 528 pages, $175.
In the brief period since the first edition of the book was published in 1988, there has been a huge increase in knowledge about pharmacokinetics. This increase has been associated both with fundamental scientific advantages, globalization of pharmaceutical drug discovery, and development on the one hand, and with the challenges of cost containment and increasing regulatory demands on the other. The authors expect that readers will absorb thelatest concepts and developments in the area of pharmacokinetics from the perspective of those actively working in the regulatory, industrial and academic environments.” The book does not focus solely on traditional compartmental theory, mathematical calculation techniques, and their clinical application. It also includes many topics that are rapidly changing within the framework of the application of pharmacokinetic principles, including comprehensive overviews of some specific and practical materials in modern pharmacokinetics. The book begins with the principles of good laboratory practice regulations applied to pharmacokinetics. Topics include industrial aspects in drug absorption, drug delivery systems, peptide and protein drug delivery, and membrane transport. Drug distribution is addressed in chapters on blood-brain barrier permeability, pharmacokinetic and pharmacodynamic relationship of drugs acting on the central nervous system, and wholebody autoradiography. Two chapters discuss recent advances in drug metabolism methodology and the use of hepatic in vitro systems as models for human drug metabolism. The latter part of the book focuses on drug development with chapters on the monolithic approach of integration of pharmacokinetics into development, nonclinical and clinical pharmacokinetics in drug discovery and development, and population pharmacokinetics and pharmacodynamics. The book concludes with regulatory perspectives on bioavailability and bioequivalence of oral controlled-release products, and statistical issues relating to bioavailability and bioequivalence studies, which include the study design and data analysis of bioequivalence . The book includes many well-written, easy-to-understand, appropriately detailed articles. It includes many often overlooked topics on regulatory, scientific, and economic aspects of drug development. Readers will find many stimulating commentaries and well-addressed issues. The chapter on population pharmacokinetics provides a particularly comprehensive and easy-to-understand overview of this subject. The chapter “Bioavailability and bioequivalence of oral controlledrelease products: a regulatory perspective” provides an inside view of the FDA’s perspectives with recent developments and possible concerns for the future. The chapter on clinical pharmacokinetics discusses and summarizes the study designs, objectives, and the uses of pharmacokinetic studies in clinical phases I, II, and III. The book discusses many other topics concerning the development, diversity, Controlled Clinical Trials 17:268-269 (1996) @ Ning Li and He Sun, 1996 655 Avenue of the Americas, New York, NY 10010
Q197-2456/96 SSDI 0197-2456(95)00262-6
Book Reviews
269
application, and details of pharmacokinetics theory. The book will be useful for those in industry and academia as well as regulatory agencies as an introduction to many important, newly developed concepts. The book provides 67 figures and 40 tables that enhance its readability. The very rich list of references at the end of each chapter provide additional source material for each topic covered. The reviewer believes that the book is worthwhile not only for libraries but also as a personal reference. Ning Li, M.D., Ph.D. Westat, Inc./Biostatistics, and He Sun, Ph.D. FDA/CEDER/Biophamaceutics
Pharmacokinetics: Regulatory-Industrial-Academic Perspectives, 2nd Ed., by Peter G. Welling and Francis L. S. Tse, Marcel Dekker, Inc., New York, 1995, 528 pages, $175.
In the brief period since the first edition of the book was published in 1988, there has been a huge increase in knowledge about pharmacokinetics. This increase has been associated both with fundamental scientific advantages, globalization of pharmaceutical drug discovery, and development on the one hand, and with the challenges of cost containment and increasing regulatory demands on the other. The authors expect that readers will absorb thelatest concepts and developments in the area of pharmacokinetics from the perspective of those actively working in the regulatory, industrial and academic environments.” The book does not focus solely on traditional compartmental theory, mathematical calculation techniques, and their clinical application. It also includes many topics that are rapidly changing within the framework of the application of pharmacokinetic principles, including comprehensive overviews of some specific and practical materials in modern pharmacokinetics. The book begins with the principles of good laboratory practice regulations applied to pharmacokinetics. Topics include industrial aspects in drug absorption, drug delivery systems, peptide and protein drug delivery, and membrane transport. Drug distribution is addressed in chapters on blood-brain barrier permeability, pharmacokinetic and pharmacodynamic relationship of drugs acting on the central nervous system, and wholebody autoradiography. Two chapters discuss recent advances in drug metabolism methodology and the use of hepatic in vitro systems as models for human drug metabolism. The latter part of the book focuses on drug development with chapters on the monolithic approach of integration of pharmacokinetics into development, nonclinical and clinical pharmacokinetics in drug discovery and development, and population pharmacokinetics and pharmacodynamics. The book concludes with regulatory perspectives on bioavailability and bioequivalence of oral controlled-release products, and statistical issues relating to bioavailability and bioequivalence studies, which include the study design and data analysis of bioequivalence . The book includes many well-written, easy-to-understand, appropriately detailed articles. It includes many often overlooked topics on regulatory, scientific, and economic aspects of drug development. Readers will find many stimulating commentaries and well-addressed issues. The chapter on population pharmacokinetics provides a particularly comprehensive and easy-to-understand overview of this subject. The chapter “Bioavailability and bioequivalence of oral controlledrelease products: a regulatory perspective” provides an inside view of the FDA’s perspectives with recent developments and possible concerns for the future. The chapter on clinical pharmacokinetics discusses and summarizes the study designs, objectives, and the uses of pharmacokinetic studies in clinical phases I, II, and III. The book discusses many other topics concerning the development, diversity, Controlled Clinical Trials 17:268-269 (1996) @ Ning Li and He Sun, 1996 655 Avenue of the Americas, New York, NY 10010
Q197-2456/96 SSDI 0197-2456(95)00262-6
Book Reviews
269
application, and details of pharmacokinetics theory. The book will be useful for those in industry and academia as well as regulatory agencies as an introduction to many important, newly developed concepts. The book provides 67 figures and 40 tables that enhance its readability. The very rich list of references at the end of each chapter provide additional source material for each topic covered. The reviewer believes that the book is worthwhile not only for libraries but also as a personal reference. Ning Li, M.D., Ph.D. Westat, Inc./Biostatistics, and He Sun, Ph.D. FDA/CEDER/Biophamaceutics