Principles of Clinical Pharmacology

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

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

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 discovery Chapter 29 Pre-clinical development Chapter 30 Animal scale up Chapter 31 Phase I studies Chapter 32 PK and PD considerations in the development of biotechnology products and large molecules Chapter 33 Design of clinical development programs Chapter 34 Good design practices for clinical trials Chapter 35 Role of the FDA in guiding drug development Appendix I Table of Laplace Transforms Appendix II Answers to Study Problems