دانلود کتاب Development of FDA-Regulated Medical Products - Prescription Drugs, Biologics, and Medical Devices

Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. This revised edition includes: updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. The author also covers the Food and Drug Administration’s Modernization Act (FDAMA), along with discussions on intellectual property, pharmacoeconomics, and technological and medical trends. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices industry. Helpful references include a glossary, acronyms, and a list of useful resources. Content: Front Matter • List of Figures and Tables Prefaces • Abbreviations • Table of Contents •Part I. Unique Challenges in Medical Product Development• 1. Healthcare in the United States 2. It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation 3. Product Liability and Product Development •Part II. Bringing a New Medical Product to Market 4. Overview of the Approval Processes for Drugs, Biologics, and Medical Devices • 5. Designing-in Quality 6. Designing-out Disaster: Risk Analysis 7. Recalls, Revocations, and Withdrawals • 8. Human Factors and the Nature of Relationships: Minimizing Medical Errors 9. Is it Safe and Does it Work?: Evaluating Safety and Efficacy in Clinical Trials 10. How Much is the Product Really Worth?: Outcomes Research, Pharmacoeconomics, and Managed Care •Part III. Product Development Planning 11. Models and Metaphors: Product Development and the Product Development Organization 12. Components of Product Development Planning: The Product Development Process 13. Components of Product Development Planning: Development Portfolio Management • 14. Components of Product Development Planning: Technology Assessment • 15. Components of Product Development Planning: Technology Forecasting 16. More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality 17. Where Do We Go from Here? • Endnotes • Glossary • Resources Index