Timing of Toxicological Studies to Support Clinical Trials

Parkinson, Christopher (EDT); McAuslane, Neil (EDT); Lumley, Cyndy (EDT); Walker, Stuart (EDT)

ISBN 10: 0792388720 / ISBN 13: 9780792388722

Edité par Springer, 1995

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Détails bibliographiques

• Titre: Timing of Toxicological Studies to Support Clinical Trials
• Éditeur: Springer
• Date de parution: 1995
• Langue: anglais
• ISBN à 10 chiffres: 0792388720
• ISBN à 13 chiffres: 9780792388722
• Reliure: Couverture rigide
• État de l'article: As New

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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.