Drug Development, Regulatory Assessment, and Postmarketing Surveillance

  • William M. Wardell
  • Giampaolo Velo

Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)

Table of contents

  1. Front Matter
    Pages i-x
  2. Introduction: Science and Government in Drug Development, Regulatory Assessment, and Postmarketing Surveillance

  3. Drug Assessment and Regulation

    1. Front Matter
      Pages 15-15
    2. Preclinical Requirements, Guidelines, and Regulations: Public Safety and Impact on Drug Development

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

      1. M. N. G. Dukes
        Pages 61-63
      2. William M. Wardell, Giampaolo Velo
        Pages 71-75
    4. The Problem of Special Populations in Providing Evidence of Safety and Efficacy for Drug Registration

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

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

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

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

    9. Harmonization of Drug Regulatory Requirements

    10. Institutional Review Boards

      1. Michael Weintraub
        Pages 175-177
  4. Postmarketing Surveillance

    1. Front Matter
      Pages 179-179
    2. Reflections on the Report of the United States’ Joint Commission on Prescription Drug Use

    3. Using PMS-Derived Information

      1. Judith K. Jones
        Pages 203-216
      2. D. H. Lawson
        Pages 217-224
      3. William M. Wardell, Giampaolo Velo
        Pages 229-230
    4. National and International Systems for Postmarketing Surveillance

      1. J. P. Griffin
        Pages 241-249
  5. Simulation of the Drug Approval Process and Postmarketing Surveillance

    1. Front Matter
      Pages 251-251
    2. Simulation of Drug Assessment: Katastrophex and Rejuvenal

    3. Postmarketing Surveillance Simulation

  6. Back Matter
    Pages 291-356

About this book


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

Editors and affiliations

  • William M. Wardell
    • 1
  • Giampaolo Velo
    • 2
  1. 1.The University of Rochester School of Medicine and DentistryRochesterUSA
  2. 2.University of PaduaVeronaItaly

Bibliographic information