Drug Development, Regulatory Assessment, and Postmarketing Surveillance

1. Front Matter

   Pages i-x

   PDF

2. Introduction: Science and Government in Drug Development, Regulatory Assessment, and Postmarketing Surveillance

   1. Introduction: Science and Government in Drug Development, Regulatory Assessment, and Postmarketing Surveillance

      • William M. Wardell

      Pages 1-13

3. Drug Assessment and Regulation

   1. Front Matter

      Pages 15-15

      PDF

   2. Preclinical Requirements, Guidelines, and Regulations: Public Safety and Impact on Drug Development

      1. Preclinical Testing of New Drugs the CPMP Guidelines as a Model for International Harmonisation

         • J. P. Griffin

         Pages 19-36

      2. Preclinical Guidelines for the Testing of New Drugs: Pharmacodynamic Aspects

         • F. Gross

         Pages 37-42

      3. Preclinical Guidelines: A Reply

         • George Zajicek

         Pages 43-57

   3. Clinical Requirements, Guidelines, and Regulations: Current Status and Future Prospects

      1. The Development of Clinical Guidelines

         • M. N. G. Dukes

         Pages 61-63

      2. Clinical Guidelines for the Assessment and Evaluation of Drugs

         • F. Gross

         Pages 64-70

      3. Clinical Guidelines Session

         • William M. Wardell, Giampaolo Velo

         Pages 71-75

   4. The Problem of Special Populations in Providing Evidence of Safety and Efficacy for Drug Registration

      1. The Problem of Special Populations and Issues of Safety and Efficacy for Drug Registration

         • D. R. Laurence

         Pages 79-84

      2. Special Populations and Evidence of Safety and Efficacy for Drug Registration

         • Marc Bogaert

         Pages 85-89

      3. Special Populations: Summary of the Discussion

         • William M. Wardell, Giampaolo Velo

         Pages 90-93

   5. The Repeated Examination of Data: Is it Scientific? Is it Ethical?

      1. Sensitivity of Therapeutic Trials: Sequential Analysis: Peeking at Interim Results: Is it Scientific? Is it Ethical?

         • D. R. Laurence

         Pages 97-109

      2. Some Problems of Multiplicity in Long-Term Intervention Studies

         • Michael Gent

         Pages 110-117

      3. Sequential Analysis: Reply to the Presentations

         • William M. Wardell, Giampaolo Velo

         Pages 119-119

   6. Taking Account of Characteristics of Therapy in the Analysis of Clinical Trials

      1. Strategies for Improving the Efficiency of Long-Term Intervention Studies

         • Michael Gent

         Pages 123-133

      2. Characteristics of Therapy in Statistical Analysis

         • Max Hamilton

         Pages 134-138

   7. The Scientific and Ethical Basis of the Evaluation of Medicines: Are Randomized Controlled Studies Inherently Unethical and Illegal?

      1. Report: The Scientific and Ethical Basis of the Clinical Evaluation of Medicines

         • William M. Wardell, Giampaolo Velo

         Pages 141-152

      2. General Introduction to the Ditchley Report

         • D. R. Laurence

         Pages 153-154

   8. What has been Achieved by Drug Regulations and Drug Regulators?

      1. The Effects of Drug Regulation: A Systematic Analysis

         • M. N. G. Dukes, Inga Lunde

         Pages 157-161

This volume is the outcome of the International School of Phar­ macology course sponsored as a NATO Advanced Study Institute and held in Erice (Sicily) at the Ettore Majorana Centre for Scientific Culture from October 3 through 12, 1980. The course, which consisted of lectures and teaching seminars, examined issues of international importance in all phases of drug development, assessment, and regu­ lation. In order to recreate both the atmosphere and substance of the meeting, a variety of materials are included here: the papers pre­ sented by the lecturers, a selection of key items from the supple­ mentary materials provided by the lecturers to the participants, notes on issues raised during the discussions, and accounts of certain special sessions arranged in response to interests expressed by those attending. The course covered two broad areas represented here by parts of the book. Part I, "Drug Assessment and Regulation," is based on the nine sessions of the course that ranged in focus from recent developments in the science of clinical pharmacology and drug development to discussions of whether and how the regulation of drug development can (or should) be harmonized internationally. In Part 11, "Postmarketing Surveillance," many aspects of this important subject are presented. Arguments outlining the potential benefits of national and international postmarketing surveillance systems are qualified by consideration of the problems inherent in devising and using these systems.

• drug
• drug development
• marketing
• pharmacology

• The University of Rochester School of Medicine and Dentistry, Rochester, USA

  William M. Wardell

• University of Padua, Verona, Italy

  Giampaolo Velo

Policies and ethics