The Timing of Toxicological Studies to Support Clinical Trials (CMR Workshop) - Hardcover

Hardcover

ISBN 10: 0792388720 ISBN 13: 9780792388722

Publisher: Springer, 1995

Synopsis

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.

About this title

Synopsis:

The timing of toxicological studies in relation to the clinical evaluation of new medicines is a key topic for strategic planners in the industry and those involved with harmonisation. Resolving the anomalies between different regulatory authorities should eliminate redundant testing on animals and improve the efficiency of the developmental process by encouraging single international strategies. To aid industry in reaching a consensus, the Centre for Medicines Research brought together representatives of the pharmaceutical industry from Europe, Japan and the U.S.A., to give a comprehensive account of current international industry positions on the subject.The contributions review the situation and address the clinical and strategic requirements of the preclinical programme. Personal and consensus proposals on the toxicity studies required to initiate clinical investigations, the timing of reproductive toxicity tests and the duration of repeat-dose studies to support clinical development are provided.

About this edition

• Publisher: Springer
• Publication date: 1995
• ISBN 10: 0792388720
• ISBN 13: 9780792388722
• Binding: Hardcover
• Number of pages: 166
• Editor: Parkinson C., McAuslane N., Lumley C., Walker S.R.