Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science.


The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics

Key Features

* Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions.
* Offers an expanded regulatory section that addresses US and international issues and guidelines.
* Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response.
* Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III.


Clinical pharmacologists, pharmacologists, clinicians and scientists working in the pharmaceutical industry and government regulatory agencies

Table of Contents

Tentative TOC: Chapter 1 Introduction PART 1: PHARMACOKINETICS: Chapter 2 Clinical pharmacokinetics Chapter 3 Compartmental analysis of drug distribution Chapter 4 Drug absorption and bioavailability Chapter 5 Effects of renal disease on pharmacokinetics Chapter 6 Kinetics of hemodialysis and hemofiltration Chapter 7 Effects of liver disease on pharmacokinetics Chapter 8 Noncompartmental vs. compartmental approaches to pharmacokinetic analysis Chapter 9 Distributed models of drug kinetics Chapter 10 Population pharmacokinetics PART 2: DRUG METABOLISM AND TRANSPORT: Chapter 11 Pathways of drug metabolism Chapter 12 Biochemical mechanisms of drug toxicity Chapter 13 Chemical assay of drugs and drug metabolites Chapter 14 Equilibrative and concentrative transport Chapter 15 Pharmacogenetics Chapter 16 Drug interactions PART 3: ASSESSMENT OF DRUG EFFECTS: Chapter 17 Physiological and laboratory markers of drug effect Chapter 18 Dose response and concentration response analysis Chapter 19 Kinetics of pharmacologic effect Chapter 20 Disease progression models PART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY: Chapter 21 Sex differences in pharmacokinetics and pharmacodynamics Chapter 22 Drug therapy in pregnant and nursing women Chapter 23 Drug therapy in neonates and pediatric patients Chapter 24 Drug therapy in the elderly Chapter 25 Clinical analysis of adverse drug reactions Chapter 26 Quality assessment of drug therapy PART 5: DRUG DISCOVERY AND DEVELOPMENT: Chapter 27 Project management Chapter 28 Drug discover


No. of pages:
© 2013
Academic Press
Print ISBN:
Electronic ISBN:

About the authors

Arthur Atkinson, Jr.

Affiliations and Expertise

Northwestern University, Chicago, Illinois , U.S.A.

Shiew-Mei Huang

Affiliations and Expertise

FDA, Silver Spring, Maryland, U.S.A.

Juan Lertora

Affiliations and Expertise

NIH Clinical Center, Bethesda, MD, U.S.A.

Sanford Markey

Affiliations and Expertise

National Institute of Mental Health, Bethesda, Maryland, U.S.A.


"…this is an excellent textbook that provides a comprehensive overview of the fundamentals and state of the art of clinical pharmacology. It will be an invaluable reference source for many current and future scientists in the field."--Clinical Pharmacology & Therapeutics, June 2013
"Recent advances in pharmacogenetics, membrane transport, and biotechnology warrant a second edition of this excellent book...This will serve as an excellent text for an advanced course in principles of clinical pharmacology for graduate students, physicians, and PharmDs. Because of recent advances, the second edition is welcome."--Thomas L. Pazdernik, PhD, University of Kansas Medical Center, FOR DOODY'S (4 Stars)