The Timing of Toxicological Studies to Support Clinical Trials
The Timing of Toxicological Studies to Support Clinical Trials Books
Product Description
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 caught up with harmonisation. Resolving the anomalies between different regulatory authorities should eliminate redundant testing on animals and improve the efficiency of the developmental administer 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 theme. The contributions review the situation and address the clinical and strategic requirements of the preclinical programme. Private and consensus proposals on the toxicity studies required to initiate clinical investigations, the timing of reproductive toxicity tests and the duration of do again-dose studies to support clinical development are provided.
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