Drug Development, Regulatory Assessment, and Postmarketing Surveillance

Introduction: Science and Government in Drug Development, Regulatory Assessment, And Postmarketing Surveillance.- I Drug Assessment and Regulation.- 1. Preclinical Requirements, Guidelines, and Regulations: Public Safety and Impact on Drug Development 17.- Preclinical testing of new drugs: the CPMP Guidelines as a model for international harmonization.- Preclinical guidelines for the testing of new drugs: pharmacodynamic aspects.- Preclinical guidelines: a reply.- 2. Clinical Requirements, Guidelines, and Regulations: Current Status and Future Prospects 59.- The development of clinical guidelines.- Clinical guidelines for the assessment and evaluation of drugs.- Clinical guidelines session.- 3. The Problem of Special Populations in Providing Evidence of Safety and Efficacy for Drug Registration 77.- The problem of special populations and issues of safety and efficacy for drug registration.- Special populations and evidence of safety and efficacy for drug registration.- Special populations: summary of the discussion.- 4. The Repeated Examination of Data: Is It Scientific? Is It Ethical? 95.- Sensitivity of therapeutic trials: sequential analysis: peeking at interim results: Is it scientific? Is it ethical?.- Some problems of multiplicity in long-term intervention studies.- Sequential analysis: reply to the presentations.- 5. Taking Account of Characteristics of Therapy in the Analysis of Clinical Trial 121.- Strategies for improving the efficiency of long-term intervention studies.- Characteristics of therapy in statistical analysis.- 6. The Scientific and Ethical Basis of the Evaluation of Medicines: Are Randomized Controlled Studies Inherently Unethical and Illegal? 139.- Report: The scientific and ethical basis of the clinical evaluation of medicines.- General introduction to the Ditchley Report.- 7. What Has Been Achieved By Drug Regulation and Drug Regulators? 155.- The effects of drug regulation: a systematic analysis..- Response to the presentation by Dr. M. N. G. Dukes and Dr. Inga Lunde on the effects of regulation.- 8. Harmonization of Drug Regulatory Requirements 165.- Harmonization of regulatory requirements: centralization in the Benelux countries.- A view on harmonization.- 9. Institutional Review Boards 173.- Institutional review boards: a particular view.- II Postmarketing Surveillance.- 10. Reflections on the Report of the United States’ Joint Commission on Prescription Drug Use 181.- Summary of the Report of the Joint Commission on Prescription Drug Use, Inc..- Joint Commission on Prescription Drug Use.- 11. Using PMS-Derived Information 201.- Broader uses of post-marketing surveillance.- Postmarketing surveillance: a case study.- Using postmarketing surveillance information: a reply.- Broader use of post-marketing surveillance - discussion.- 12. National and International Systems for Postmarketing Surveillance 231.- National/international systems for post-marketing surveillance.- Post-marketing surveillance.- III Simulation of the Drug Approval Process and Postmarketing Surveillance.- 13. Simulation of Drug Assessment: Katastrophex and Rejuvenal 253.- New drug application submitted to the Erician Registration Committee (Clinical Section): Katastrophex.- The Katastrophex meeting: minutes and discussion.- Bad drug applications: “Katastrophex” critique.- New drug application submitted to the Erician Registration Committee (Clinical Section): Rejuvenal.- The Rejuvenal meeting: minutes and discussion.- 14. Postmarketing Surveillance Simulation 279.- Post-marketing surveillance: hypothetical problems.- Append.-Medical research: Civil liability and compensation for personal injury. A discussion paper prepared by a Ciba Foundation Study Group.- Directions and implications of drug legislation and regulation in Europe.- Proposal for a Council Recommendation concerning tests relating to the placing on the market of proprietary medicinal products. Commission of the European Communities. COM(80) 789 final (28 November 1980).- List of Contributors.