The Timing of Toxicological Studies to Support Clinical Trials

1. Front Matter

   Pages i-xvi

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2. Introduction and Presentations

   1. Front Matter

      Pages 1-1

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   2. The application of toxicological investigations in the safe development of medicines

      • Robert Zerbe

      Pages 3-16

   3. Review of international recommendations on animal toxicity studies and their relation to clinical exposure

      • David Scales, Toshimi Usui

      Pages 17-25

   4. International survey on the timing of toxicity studies in relation to clinical trials

      • Christopher Parkinson

      Pages 27-39

   5. Considerations for implementing a toxicity testing strategy

      • Douglas M Morton

      Pages 41-49

3. Personal Views

   1. Front Matter

      Pages 51-51

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   2. Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a toxicologist’s opinion

      • Herman Van Cauteren

      Pages 53-60

   3. Phase I clinical trials: what is the minimum preclinical package necessary for initiating single-dose studies in man? — a clinical pharmacologist’s opinion

      • Diane Jorkasky

      Pages 61-65

   4. The duration of toxicity studies required to support repeated dosing in clinical investigation — a toxicologist’s opinion

      • Toshiji Igarashi

      Pages 67-74

   5. The duration of toxicity studies required to support repeated dosing in clinical investigation — a clinician’s opinion

      • Kurt Suter

      Pages 75-83

   6. Reproductive and developmental toxicity studies required to support the inclusion of women and children in clinical trials — a toxicologist’s opinion

      • Kurt Suter

      Pages 85-93

4. Proposals and the Way Forward

   1. Front Matter

      Pages 95-98

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   2. The minimum non-clinical package for initiating Phase I clinical trials

      • Michael R Jackson, Jack H Dean

      Pages 99-108

   3. The duration of toxicity studies required to support repeated dosing in humans in clinical investigation

      • Philip Bentley, Alan Dunton

      Pages 109-114

   4. The timing of reproductive toxicity studies in relation to clinical trials

      • Jeanne M Manson, Fritz R Bühler

      Pages 115-125

   5. The way forward

      • Gwyn Morgan

      Pages 127-131

   6. Input to ICH

      • R Michael McClain

      Pages 133-139

5. Back Matter

   Pages 141-150

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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.

• clinical trial
• efficiency
• pharmacology
• research
• toxicity

• Centre for Medicines Research, Carshalton, UK

  Christopher Parkinson, Neil McAuslane, Cyndy Lumley, Stuart Walker

Policies and ethics