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The Timing of Toxicological Studies to Support Clinical Trials

  • Book
  • © 1994

Overview

Editors:
  1. Christopher Parkinson

    1. Centre for Medicines Research, Carshalton, UK

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  2. Neil McAuslane

    1. Centre for Medicines Research, Carshalton, UK

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  3. Cyndy Lumley

    1. Centre for Medicines Research, Carshalton, UK

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  4. Stuart Walker

    1. Centre for Medicines Research, Carshalton, UK

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Table of contents (14 chapters)

  1. Front Matter

    Pages i-xvi
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  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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Keywords

About this book

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.

Editors and Affiliations

  • Centre for Medicines Research, Carshalton, UK

    Christopher Parkinson, Neil McAuslane, Cyndy Lumley, Stuart Walker

Bibliographic Information

  • Book Title: The Timing of Toxicological Studies to Support Clinical Trials

  • Editors: Christopher Parkinson, Neil McAuslane, Cyndy Lumley, Stuart Walker

  • DOI: https://doi.org/10.1007/978-94-011-1424-0

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Kluwer Academic Publishers 1994

  • Hardcover ISBN: 978-0-7923-8872-2Published: 31 January 1995

  • Softcover ISBN: 978-94-010-4623-7Published: 27 September 2012

  • eBook ISBN: 978-94-011-1424-0Published: 06 December 2012

  • Edition Number: 1

  • Number of Pages: XVI, 150

  • Topics: Pharmacology/Toxicology, Public Health

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