Main description:

This book provides a concise overview of recent advances in Pharmacokinetics (PK) and Pharmacodynamics (PD). The pharmacokinetics section covers the state of the art inPhysiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2). Chapters 3 and 4 describe the recent development ofPhysiologically Based Finite Time Pharmacokinetic (PBFTPK) models and
their applications to pharmacokinetic data. The pharmacodynamics section focuses on PK/PD modeling. Chapter 5 providesan overview of PK/PD modeling and simulation in clinical practice and
studies. Chapter 6 deals with the subject/physiology variability issue encountered in PK/PD studies, while Chapter 7 reviews the influence ofclinical pharmacology in the modernization of drug development and regulation. This book is an essential reference for pharmaceutical scientists.

Contents:

Pharmacokinetics1. Current status in PBPK modeling.

Ryuta Asaumi, Kiyohiko Sugano, Ritsumeikan University, Japan suganok@fc.ritsumei.ac.jp

2. Physiologically based biopharmaceutics modeling (PBBM) Application on Food Effect Assessment.

Di Wu, John P. Gleeson, Filippos Kesisoglou, Biopharmaceutics Group, Merck, New Jersey, USA filippos_kesisoglou@merck.com

3. Physiologically based finite time pharmacokinetic (PBFTPK) models: Inception and development

Athanasios A. Tsekouras and Panos Macheras, National and Kapodistrian University of Athens, Greece macheras@pharm.uoa.gr

4. Physiologically based finite time pharmacokinetic (PBFTPK) models: Applications

Athanasios A. Tsekouras, Nikos Alimpertis, and Panos Macheras, National and Kapodistrian University of Athens, Greece macheras@pharm.uoa.gr

Pharmacodynamics

5. Pharmacokinetic - Pharmacodynamic Modelling and Simulation in Clinical Practice and Studies

Thomas P.C. Dorlo & Elin M. Svensson tdorlo@page-meeting.org

6. On the Verge of Impossibility: Accounting for Variability Arising from Permutations of Comorbidities that Affect the Fate of Drugs in the Human Body.

Amin Rostami-Hodjegan, University of Manchester, Vice President of Research & Development at Simcyp Ltd (a Certara Company) amin.rostami@manchester.ac.uk and Brahim Achour brahim.achour@manchester.ac.uk

7. Impact of Clinical Pharmacology on the Modernization of Drug Development and RegulationCarl Peck ccpeck@icloud.com and Liang Zhao liang.zhao@fda.hhs.gov