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

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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/2021038143LC 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.

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, recruitment challenges, lockdown, logistics issues, and confounding disease influence on outcomes. Along with World Health Organization's SOLIDARITY trial and Institut national de la santé et de la recherche médicale (INSERM)'s Discovery trial, nearly thousand clinical studies related to COVID‐19 have been registered worldwide in the first half of 2020. In a race against time to bring innovative medicines to the market, a heightened need for Model‐Informed Drug Development (MIDD) and the totality of evidence it advocates has become apparent. The applications of PBPK modeling, an important component of MIDD, supporting dose optimization and assessment of benefit‐risk ratios have been further catalyzed by the pandemic.