Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations. Sheila Annie Peters

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      PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODELING AND SIMULATIONS

      Principles, Methods, and Applications in the Pharmaceutical Industry

       Second Edition

       Sheila Annie Peters

      Merck Healthcare

      Translational Quantitative Pharmacology

      Darmstadt

      Germany

      This edition first published 2022

      © 2022 by John Wiley & Sons, Inc.

      Edition History Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, 1st Edition, © 2012 by John Wiley & Sons, Inc.

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      Library of Congress Cataloging‐in‐Publication Data Names: Peters, Sheila Annie, author. Title: Physiologically based pharmacokinetic (PBPK) modeling and simulations : principles, methods, and applications in the pharmaceutical industry / Sheila Annie Peters. Description: Second edition. | Hoboken, NJ : Wiley, 2021. | Includes bibliographical references and index. Identifiers: LCCN 2021038143 (print) | LCCN 2021038144 (ebook) | ISBN 9781119497684 (hardback) | ISBN 9781119497769 (adobe pdf) | ISBN 9781119497790 (epub) Subjects: MESH: Pharmacokinetics | Drug Design | Models, Biological Classification: LCC RM301.5 (print) | LCC RM301.5 (ebook) | NLM QV 38 | DDC 615.7–dc23 LC record available at https://lccn.loc.gov/2021038143 LC ebook record available at https://lccn.loc.gov/2021038144

      Cover Design: Wiley

      Cover Image: Courtesy of Sheila Annie Peters

       To my readers whose tremendous support for the first edition inspired me to give my best to this edition.

      PREFACE TO THE SECOND EDITION

      I am excited to bring out this much improved second edition, encouraged by the success of the first edition of “Physiologically‐Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry”. The applications of PBPK modeling and simulations have exponentially grown since the publication of the first edition of the book in 2012. Since that time, a surge in PBPK regulatory submissions has prompted the regulatory agencies to release guidelines for the reporting of PBPK modeling results that accompany submissions.

      The adverse impact of the COVID‐19 pandemic on global economies is still being evaluated. Pharma companies have had their fair share of losses too. Clinical studies for various indications have been affected by stretched healthcare infrastructure,