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The Timing of Toxicological Studies to Support Clinical Trials

  • Christopher Parkinson
  • Neil McAuslane
  • Cyndy Lumley
  • Stuart Walker

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Introduction and Presentations

  3. Personal Views

  4. Proposals and the Way Forward

    1. Front Matter
      Pages 95-98
    2. Gwyn Morgan
      Pages 127-131
    3. R Michael McClain
      Pages 133-139
  5. Back Matter
    Pages 141-150

About this book

Introduction

Over the past twelve years, the Centre for Medicines Research has held a series of Workshops on a number of topics related to the drug discovery and development process. The major objective of these Workshops has been to provide an international forum for regula­ tory, academic and industry representatives to debate together, and suggest solutions to, specific problems. The meeting reported in this volume represents a departure from this approach, in that the par­ ticipants were drawn largely from the pharmaceutical industry. Senior clinicians, pharmacologists and toxicologists from companies in Europe, the USA and Japan met in May 1994 to discuss a scientific rationale for the conduct of toxicity studies to support the clinical development of new medicines, and to begin to work towards an industry consensus. Achievement of such a consensus is seen as an important step in the process leading towards international harmon­ isation of the recommendations on the timing of toxicity studies in relation to clinical trials.

Keywords

clinical trial efficiency pharmacology research toxicity

Editors and affiliations

  • Christopher Parkinson
    • 1
  • Neil McAuslane
    • 1
  • Cyndy Lumley
    • 1
  • Stuart Walker
    • 1
  1. 1.Centre for Medicines ResearchCarshaltonUK

Bibliographic information