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CARCINOGENICITY STUDIES FOR DRUGS GIVEN OVER SIX MONTH DURATION RECOMMENDED IN ICH DRAFT GUIDELINE; ICH BIOTECH STABILITY DRAFT GUIDANCE OUT FOR COMMENT

Executive Summary

Carcinogenicity studies are being recommended for pharmaceuticals that are used in chronic treatment of diseases for at least six months' duration, according to the draft "International Conference on Harmonization Guideline on Conditions Which Require Carcinogenicity Studies for Pharmaceuticals." The draft (Step 2) guideline was released for consultation at the ICH Steering Committee meeting March 28-30 in Washington, D.C.
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PS026118

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