Principles and Practice of Pharmaceutical Medicine

About the Editors. List of Contributors. Preface. Section 1: Overview of Pharmaceutical Medicine. 1. Pharmaceutical Medicine as a Medical Speciality (Michael D. Young). 2. What Pharmaceutical Medicine Is and Who Does It (W. Wardell, Susan Toland, and Anthony W. Fox). 3. Competency based Training System for Clinical Research Staff (Jay D. Miller). Section II: Drug Discovery and Development. Introduction (Lionel D. Edwards and Anthony W. Fox). 4. Drug Discovery: Design and Serendipity (Leslie J. Molony). 5. Pharmaceutics (Anthony W. Fox). 6. Non clinical Toxicology (Frederick Reno). 7. Informed Consent (Anthony W. Fox). 8. Good Clinical Practices (Wendy Bohaychuk and Graham Ball). 9. Quality Assurance, Quality Control and Audit (Donna Cullen). 10. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Experience (Stephen Curry, Dennis McCarthy, Heleen H. DeCory, Matthew Marler, and Johan Gabrielsson). 11. Phase II and Phase III Clinical Studies (Anthony W. Fox). 12. Phase IV Drug Development: Post marketing Studies (Lisa R. Johnson Pratt). 13. Over the counter Medicines (Paul Starkey). Section III: Special Populations. Introduction (Lionel D. Edwards). 14. Drug Research in Older Patients (Lionel D. Edwards). 15. Drug Development Research in Women (Lionel D. Edwards). 16. Clincial Research in Children (Lionel D. Edwards). Section IV: Applied Aspects of Drug Development. Introduction (Anthony W. Fox). 17. Biotechnology Products and Their Development (David Shapiro and Anthony W. Fox). 18. Orphan Drugs (Bert Spilker). 19. Pharmacoeconomics: Economic and Humanistic Outcomes (Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer). 20. Pharmacoepidemiology and the pharmaceutical Physician (Hugh Tilson). 21. Statistical Principles and Their Application in Biopharmaceutical Research (Dan Anbar). 22. Data Management (T.Y. Lee and Michael Minor). 23. Patient Compliance (Jean Michel Metry). 24. Complementary Medicine (Anthony W. Fox). Section V: Drug Registration. Introduction (Anthony W. Fox). 25. United States Regulations (William Kennedy). 26. Emergency and Compassionate use INDs and Accelerated NDA and ANDA approvals Procedures, Benefits and Pitfalls (Anthony W. Fox). 27. Japanese Regulations (Etienne Labbe). 28. The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 (John Griffin). 29. Ethnic Issues in Drug Registration (Lionel D. Edwards, J.M. Husson, A. Kumagai, E. Labbe, C. Naito, M. Papaluca, S. Walker, R. Williams, M. Weintraub, and H. Yasurhara). Section VI: Medical Services. Introduction (Anthony W. Fox). 30. An Introduction to Medical Affiars (Gill Price). 31. Drug Labelling (Anthony W. Fox). 32. Organizing and Planning Local, Regional, National and International Meetings and Conferences (Zofia E. Dziewanovska, Linda Packard, and Lionel D. Edwards). 33. Drug Surveillance (Howard J. Dreskin and Win M. Castle). 34. Disease Management What Does It Mean? (Roy Lilley). 35. Publishing Clinical Studies (Anthony W. Fox). Section VII: Legal and Ethical Aspects. Introduction (Sara Croft and Tim Pratt). 36. Pharmaceutical Product Liability (Han W. Choi and Howard B. Yeon). 37. Patents (Gabriel Lopez). 38. Fraud and Misconduct in Clinical Research (Frank Wells). Section VIII: Business Aspects. The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico commercial Environment (R. Drucker and R. Graham Hughes). 40. Outsourcing Clinical Drug Development Activities to Contract Research Organisation CROs): Critical Success Factors (John R. Vogel). 41. Third World (Gamal Hammad). 42. Financial Aspects of Clinical Trials (R. Graham Hughes and N. Turner). 43. The Impact of Managed Care on the US Pharmaceutical Industry (Robert Chaponis, Christine Hanson Divers and Marilyn J. Wells). Appendix: Useful Internet Links. Index.