Principles and practice of pharmaceutical medicine /
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| Edition: | 2nd ed. |
|---|---|
| Imprint: | Chichester, West Sussex ; Hoboken, NJ : John Wiley & Sons, c2007. |
| Description: | 1 online resource. |
| Language: | English |
| Subject: | |
| Format: | E-Resource Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/8384208 |
Table of Contents:
- Preface to the First Edition
- Preface to the Second Edition
- About the Editors
- Contributors
- Section I. Overview of Pharmaceutical Medicine
- 1. The Practice and Practitioners of Pharmaceutical Medicine
- 2. Pharmaceutical Medicine as a Medical Specialty
- 3. Clinical Research Education and Training for Biopharmaceutical Staff
- Section II. Drug Discovery and Development
- Introduction
- 4. Drug Discovery: Design and Serendipity
- 5. Pharmaceutics
- 6. Non-clinical Toxicology
- 7. Informed Consent
- 8. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure
- 9. Phase II and Phase III Clinical Studies
- 10. Phase IV Drug Development: Post-Marketing Studies
- 11. Site Management
- 12. Good Clinical Practices
- 13. Quality Assurance, Quality Control, and Audit
- 14. The Unique Role of Over-the-counter Medicine
- Section III. Special Populations and Required Special Studies
- Introduction
- 15. Drug Research in Older Patients
- 16. Drug Development Research in Women
- 17. Clinical Research in Children
- 18. Racial and Ethnic Issues in Drug Registration
- 19. Hepatic and Renal Failure
- 20. Drug Interactions
- 21. Orphan Drugs
- Section IV. Applied Aspects of Drug Development
- Introduction
- 22. Biotechnology Products and Development
- 23. Pharmacoeconomics: Economic and Humanistic Outcomes
- 24. Pharmacoepidemiology and the Pharmaceutical Physician
- 25. Statistical Principles and Application in Biopharmaceutical Research
- 26. Data Management
- 27. Patient Compliance: Pharmionics, A New Discipline
- 28. Monitoring Drug Concentrations in Clinical Practice
- 29. Generics
- 30. Complementary Medicines
- Section V. Drug Regulation
- Introduction
- 31. United States Regulations
- 32. Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals
- 33. The Development of Human Medicines Control in Europe From Classical Times to the Year 2000
- 34. Medicines Regulation in the European Union
- 35. Japanese Regulations
- 36. Drug Registration and Pricing in the Middle East
- Section: VI. Medical Services
- Introduction
- 37. Medical Affairs
- 38. Drug Labeling
- 39. Drug Surveillance
- 40. Data Mining
- 41. Risk Management in Product Approval and Marketing
- 42. Publishing Clinical Studies
- 43. Organizing and Planning Lo
