Drug Development (Routledge Revivals) -- Hardback （2 New edit）

Hamner, Charles E.

Taylor & Francis Ltd（2020/06発売）

• 製本 Hardcover:ハードカバー版／ページ数 308 p.
• 言語 ENG
• 商品コード 9780367205768
• DDC分類 615

Full Description

Published in 1990comprehensive but not exhaustive summation of the complex process of drug development.

Contents

1. IntroductionCharles E. Hamner2. Program Coordination and ManagementCharles E. Hamner3. Project Cost MonitoringDavid E. Jones4. Information ManagementRichard L. Chamberlain5. Drug DesignAlfred Burger6. Approaches to Screening Compounds for Pharmacological ActivityAlfred Burger7. Biologics as Therapeutic Agents: Pitfalls and promisesMichael Williams8. Project Selection Factors in Pharmaceutical R & DRichard E. Faust9. The Statistician in Pharmaceutical DevelopmentWalter B. Cummins and Gerald B. Hajian10. ToxicologyRalph Fogleman11. Pharmaceutical Product Development from Concept to MarketAllen J. Polon12. Notice of Claimed Investigation Exemption for a New DrugJoyce Williams13. Biopharmaceutic and Pharmacokinetic StudiesJohn H. Wood14. Managing and Conducting Phase 1 and Phase 2 StudiesJohn A. Owen, Jr15. Conducting Phase 3 and Phase 4 Clinical TrialsCarlos R. Ayers16. Monitoring Clinical StudiesWinston Liao17. Preparing the New Drug ApplicationRobert A. Pearlberg18. Product Liability Issues in Drug DevelopmentWilliam G. Pappas and Kenneth D. Sibley19. Legal Aspects of Product ProtectionWilliam G. Pappas and Kenneth D. Sibley20. The Impact of Biotechnology on the Pharmaceutical Industryi21. To Start a Biotechnology Companyi22. Global Consideration in the Development and Production of PharmaceuticalsJ. David Tucker and James W. Parker