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FDA TOXICOLOGY PILOT DATABASE PROPOSED AS ALTERNATIVE TO IN VIVO

This article was originally published in The Tan Sheet

Executive Summary

FDA TOXICOLOGY PILOT DATABASE PROPOSED AS ALTERNATIVE TO IN VIVO toxicological testing at a June 28 meeting of FDA's Science Board. The proposed database would permit retrospective analysis of animal and human data to determine the correlation between the two types of data. The project would represent a First step towards replacing current in vitro toxicology and carcinogenicity tests with new molecular and cellular models, decreasing the cost of drug development and improving accuracy of rodent tests. It would also enhance FDA's ability to detect toxicity patterns that a drug company might not be able to identify.
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