Preface

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