Description
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
Table of Contents
1. IntroductionPART 1: PHARMACOKINETICS2. Clinical pharmacokinetics 3. Compartmental analysis of drug distribution 4. Drug absorption and bioavailability 5. Effects of renal disease on pharmacokinetics6. Kinetics of hemodialysis and hemofiltration7. Effects of liver disease on pharmacokinetics8. Noncompartmental vs. compartmental approaches to pharmacokinetic analysis9. Distributed models of drug kinetics10. Population pharmacokineticsPART 2: DRUG METABOLISM AND TRANSPORT11. Pathways of drug metabolism12. Biochemical mechanisms of drug toxicity13. Chemical assay of drugs and drug metabolites14. Equilibrative and concentrative transport15. Pharmacogenetics16. Drug interactionsPART 3: ASSESSMENT OF DRUG EFFECTS17. Physiological and laboratory markers of drug effect18. Dose response and concentration response analysis19. Kinetics of pharmacologic effect20. Disease progression modelsPART 4: OPTIMIZING AND EVALUATING PATIENT THERAPY21. Sex differences in pharmacokinetics and pharmacodynamics22. Drug therapy in pregnant and nursing women23. Drug therapy in neonates and pediatric patients24. Drug therapy in the elderly25. Clinical analysis of adverse drug reactions26. Quality assessment of drug therapyPART 5: DRUG DISCOVERY AND DEVELOPMENT27. Project management28. Drug discovery29. Pre-clinical development30. Animal scale up31. Phase I studies32. PK and PD considerations in the development of biotechnology products and large molecules33. Design of clinical development programs34. Good design practices for clinical trials 35. Role of the FDA in guiding drug developmentAppendixI. Table of Laplace TransformsII. Answers to Study Problems
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