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