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Sommario
1. Introduction 2. Program Coordination and Management 3. Project Cost Monitoring 4. Information Management 5. Drug Design 6. Approaches to Screening Compounds for Pharmacological Activity 7. Biologics as Therapeutic Agents: Pitfalls and promises 8. Project Selection Factors in Pharmaceutical R & D 9. The Statistician in Pharmaceutical Development 10. Toxicology 11. Pharmaceutical Product Development from Concept to Market 12. Notice of Claimed Investigation Exemption for a New Drug 13. Biopharmaceutic and Pharmacokinetic Studies 14. Managing and Conducting Phase 1 and Phase 2 Studies 15. Conducting Phase 3 and Phase 4 Clinical Trials 16. Monitoring Clinical Studies 17. Preparing the New Drug Application 18. Product Liability Issues in Drug Development 19. Legal Aspects of Product Protection 20. The Impact of Biotechnology on the Pharmaceutical Industry 21. To Start a Biotechnology Company i22. Global Consideration in the Development and Production of Pharmaceuticals
Info autore
Charles E. Hamner, Jr., D.V.M., Ph.D., is president of the North Carolina Biotechnology Center and Research Professor of Obstetrics and Gynaecology at the University of North Carolina at Chapel Hill.
Riassunto
Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.
