The first book dedicated to the emerging field of physiologically-based pharmacokinetic modeling (PBPK)
Now in its second edition, Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulations: Principles, Methods, and Applications in the Pharma Industry remains the premier reference book throughout the rapidly growing PBPK user community. Using clear and concise language, author Sheila Annie Peters connects theory with practice as she explores the vast potential of PBPK modeling for improving drug discovery and development.
This fully updated new edition covers key developments in the field of PBPK modelling and simulations that have emerged in recent years. A brand-new section provides case studies in different application areas of PBPK modelling, including drug-drug interaction, genetic polymorphism, renal impairment, and pediatric extrapolation. Additional chapters address topics such as model-informed drug development (MIDD) and expose readers to a wide range of current applications in the field. Throughout the book, substantially revised chapters simplify complex topics and offer a balanced view of both the opportunities and challenges of PBPK modelling. Providing timely and comprehensive coverage of one of the most exciting new areas of pharmaceutical science, this book:
Describes the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics
Features a wealth of new figures and case studies of the applications of PBPK modelling along the value chain in drug discovery and development
Reflects the latest regulatory guidelines on the reporting of PBPK modelling analysis
Includes access to a new companion website containing code, datasets, explanations of case examples in the text, and discussion of key developments in the field
Contains a brief overview of the field, end-of-chapter keywords for easy reference, and an extensive bibliography
Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, Second Edition is an indispensable single-volume resource for beginning and intermediate practitioners across the pharmaceutical sciences in both industry and academia.
Описание: Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to design clinical trials according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.
Описание: 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.
Автор: Strauss Название: Mathematical Modeling of Pharmacokinetic Data ISBN: 1566762049 ISBN-13(EAN): 9781566762045 Издательство: Taylor&Francis Рейтинг: Цена: 38280.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A guide to mathematical modeling and analysis of pharmacokinetic data. It covers methods for maximizing the information obtained from given data. It presents an approach to using the mathematical software tools available so that the investigator may extract the maximum information from a given set of data.
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