The Timing of Toxicological Studies to Support Clinical Trials

The Timing of Toxicological Studies to Support Clinical Trials

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Description

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.
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Product details

  • Hardback | 150 pages
  • 162.56 x 236.22 x 10.16mm | 385.55g
  • Dordrecht, Netherlands
  • English
  • 1994 ed.
  • XVI, 150 p.
  • 0792388720
  • 9780792388722

Table of contents

Section I: Introduction and Presentations.- 1 The application of toxicological investigations in the safe development of medicines.- 2 Review of international recommendations on animal toxicity studies and their relation to clinical exposure.- 3 International survey on the timing of toxicity studies in relation to clinical trials.- 4 Considerations for implementing a toxicity testing strategy.- Section II: Personal Views.- 5 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a toxicologist's opinion.- 6 Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? - a clinical pharmacologist's opinion.- 7 The duration of toxicity studies required to support repeated dosing in clinical investigation -a toxicologist's opinion.- 8 The duration of toxicity studies required to support repeated dosing in clinical investigation - a clinician's opinion.- 9 Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials - a toxicologist's opinion.- Section III: Proposals and the Way Forward.- 10 The minimum non-clinical package for initiating Phase I clinical trials.- 11 The duration of toxicity studies to support repeated dosing in clinical investigation.- 12 The timing of reproductive toxicity studies in relation to clinical trials.- The way forward.- 14 Input to ICH.- Meeting participants.
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