Key Features
- Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy
- Unusual cohesive of presentation that stems from author participation in an ongoing popular NIH course
- Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study
- Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry
- Expanded coverage of pharmacogenetics
- Expanded coverage of drug transporters and their role in interactions
- Inclusion of new material on enzyme induction mechanisms in chapters on drug metabolism and drug interactions
- A new chapter on drug discovery that focuses on oncologic agents
- Inclusion of therapeutic antibodies in chapter on biotechnology products
1. Introduction
PART 1: PHARMACOKINETICS
2. Clinical pharmacokinetics
3. Compartmental analysis of drug distribution
4. Drug absorption and bioavailability
5. Effects of renal disease on pharmacokinetics
6. Kinetics of hemodialysis and hemofiltration
7. Effects of liver disease on pharmacokinetics
8. Noncompartmental vs. compartmental approaches to pharmacokinetic analysis
9. Distributed models of drug kinetics
10. Population pharmacokinetics
PART 2: DRUG METABOLISM AND TRANSPORT
11. Pathways of drug metabolism
12. Biochemical mechanisms of drug toxicity
13. Chemical assay of drugs and drug metabolites
14. Equilibrative and concentrative transport
15. Pharmacogenetics
16. Drug interactions
PART 3: ASSESSMENT OF DRUG EFFECTS
17. Physiological and laboratory markers of drug effect
18. Dose response and concentration response analysis
19. Kinetics of pharmacologic effect
20. Disease progression models
PART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY
21. Sex differences in pharmacokinetics and pharmacodynamics
22. Drug therapy in pregnant and nursing women
23. Drug therapy in neonates and pediatric patients
24. Drug therapy in the elderly
25. Clinical analysis of adverse drug reactions
26. Quality assessment of drug therapy
PART 5: DRUG DISCOVERY AND DEVELOPMENT
27. Project management
28. Drug discovery
29. Pre-clinical development
30. Animal scale up
31. Phase I studies
32. PK and PD considerations in the development of biotechnology products and large molecules
33. Design of clinical development programs
34. Good design practices for clinical trials
35. Role of the FDA in guiding drug development
Appendix
I. Table of Laplace Transforms
II. Answers to Study Problems
Gallin: Principles and Practice of Clinical Research (Jan 2002, ISBN-10/13: 0-12-274065-3/ 978-0-12-274065-7)
Ahuja and Scypinski: Handbook of Modern Pharmaceutical Analysis (Jul 2001, ISBN-10/13: 0-12-045555-2/ 978-0-12-045555-3)
