Principles of Clinical Pharmacology, 3rd Edition

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.

Description

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.

Readership

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

Principles of Clinical Pharmacology, 3rd Edition

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 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