Bibliothèque de L'IMIST/CNRST

Includes bibliographical references and index.

Part I. History and basic principles -- 1. Introduction to drug development and regulatory decision-making -- 2. Evolution of drug development and its regulatory process -- 3. Regulatory bases for clinical pharmacology and biopharmaceutics information in a new drug application -- 4. New drug application content and review process for clinical pharmacology and biopharmaceutics -- Part II. In vitro/pre-clinical -- 5. In-vitro drug metabolism studies during development of new drugs -- 6. Drug transporters -- 7. Principles, issues, and applications of interspecies scaling -- Part III. Clinical Pharmacology -- 8. Analytical method validation -- 9. Studies of the basic pharmacokinetic properties of a drug: A regulatory perspective -- 10. Surrogate markers in drug development -- 11. Population pharmacokinetic and pharmacodynamic analysis -- 12. Scientific and regulatory considerations for studies in special population -- 13. Conducting clinical pharmacology studies in pregnant and lactating women -- 14. Scientific, mechanistic, and regulatory issues with pharmacokinetic drug-drug interactions -- 15. Assessing the effect of disease state on the pharmacokinetics of the drug -- 16. Clinical pharmacology issues related to specific drug classes during drug development -- Part IV. Biopharmaceutics -- 17. Issues in bioequivalence and development of generic drug products -- 18. Regulatory considerations for oral extended release dosage forms and in vitro (dissolution)/in vivo (bioavailability) correlations -- 19. In vivo bioavailability/bioequivalence waivers -- 20. Bioavailability and bioequivalence issues for drugs administered via different routes of administration; Inhalation/nasal products; Dermatological products; Suppositories -- Part V. Contemporary and special interest topics -- 21. Scientific and regulatory issues in development of chiral drugs -- 22. A regulatory view of lipsomal drug product characterization -- 23. Challenges in drug development: Biological agents of intentional use -- 24. The regulation of antidotes for nerve agent poisoning -- 25. Bioequivalence assessment: Approaches, designs, and statistical considerations.