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WorldCat.org

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

1 online resource (xix, 545 pages) : illustrations

This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered by the American Board of Clinical Pharmacology. This unique reference is recommended by the Board as a study text and includes modules on drug discovery and development to assist students as well as practicing pharmacologists. * 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

Principles of clinical pharmacology