Third international conference on harmonization of technical requirements for registration of pharmaceuticals for human use--a toxicologist's perspective.
This overview provides a perspective on the ICH process and outcomes based on the third international conference held in Yokohama, Japan, in November/December 1995. It is an attempt to provide awareness of this process to the toxicologic pathology community from the point of view of a practicing toxicologist and meeting attendee and to consolidate much of the information on this process in one place. The ICH process is an active, and ongoing process to improve the standardization of safety assessment testing throughout the world, and further changes will no doubt have occurred by the time this document is published.
Smith
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PF
Department of Regulatory Drug Safety, G. D. Searle and Company, Skokie, Illinois 60077, USA.
D000818:Animals; D001709:Biotechnology; D004341:Drug Evaluation / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D009153:Mutagens / Q000633:toxicity; D011247:Pregnancy; D012042:Registries; D012098:Reproduction / Q000187:drug effects; D012107:Research Design
D009153:Mutagens