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In Brief: Toxicity testing

Executive Summary

Toxicity testing: FDA guidance on "Single Dose Acute Toxicity Testing for Pharmaceuticals" published in the Aug. 26 Federal Register. The guidance is a modification of a draft guidance published as part of International Conference on Harmonization in April 1992 that sought to eliminate LD50 studies. FDA says modified document is not an ICH consensus position, but is in general agreement with ICH toxicity testing principles. The modified guidance provides information that "would allow for use of single-dose toxicity studies to support single dose studies in humans," agency says...
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PS028797

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