A natural hierarchy exists in pharmacokinetic-pharmacodynamic modeling culminating in population pharmacokinetic models, which are a specific type of nonlinear mixed effects model. The purpose of this book is to present through theory and example how to develop pharmacokinetic models, both at an individual and population level. In order to do so, however, one must first understand linear models and then build to nonlinear models followed by linear mixed effects models and then ultimately nonlinear mixed effects models. This book develops in that manner – each chapter builds upon previous chapters by first presenting the theory and then illustrating the theory using published data sets and actual data sets that were used in the development of new chemical entities collected by the author during his years in industry. A key feature of the book is the process of modeling. Most books and manuscripts often present the final model never showing how the model evolved. In this book all examples are presented in an evolutionary manner.
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This book presents both the art and science behind pharmacokinetic-pharmacodynamic modeling. Using a building-block approach, the author starts from linear and nonlinear models at the individual level and proceeds to develop more complex linear and nonlinear mixed effects models at the population level, with particular emphasis on showing the interrelationships between the various model types. The theory behind the methods are illustrated using real data drawn from the literature and from the author’s own experiences in drug development. Data are analyzed using a variety of software, including SAS, WinNonlin, SAAM II, and NONMEM. A key component of the book is to show how models are accepted and rejected, ultimately leading to a useful and informative model that can be utilized using computer simulation to answer "what-if" questions.About the Author:
Peter Bonate has 16 years industrial experience, 13 years as a clinical pharmacologist/pharmacokineticist and three years in drug metabolism and bioanalysis. He is currently a Director in the Clinical Pharmacology, Modeling, and Simulation department at GlaxoSmithKline in the oncology and rare diseases therapeutic areas. He has worked at Genzyme, Hoechst Marion Roussel, Eli Lilly, and Quintiles. He received his PhD in 1996 from Indiana University in Medical Neurobiology with an emphasis on the pharmacokinetics of drugs of abuse. He received an MS in statistics from the University of Idaho and an MS in Pharmacology from Washington State University, both in 1990. In 2003 he was elected a Fellow of the American College of Clinical Pharmacology and in 2007 was elected a fellow of the American Association of Pharmaceutical Scientists (AAPS). He was founder of the Modeling and Simulation focus group, has served as chair of the population pharmacokinetics focus group, and was the Clinical Pharmacology and Translational Research Section Chair within AAPS. He has served or currently serves on the editorial boards for the Journal of Clinical Pharmacology, Pharmaceutical Research, Journal of Pharmacokinetics and Pharmacodynamics, and The AAPS Journal. He has more than 50 publications in the field of pharmacokinetics and clinical pharmacology, is co-editor of the 3-volume series Pharmacokinetics in Drug Development published by AAPS Press in 2004 and 2011, and is author of the book Pharmacokinetic-Pharmacodynamic Modeling and Simulation published by Springer in 2006. In 2010, he became an Adjunct Assistant Professor at the Indiana University School of Medicine and the University of North Carolina, Chapel Hill.
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