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S1B - PharmaFacts
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S1B

Guidances - ICH Guidances

S1B: Testing for Carcinogenicity of Pharmaceuticals:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document provides guidance on the need to carry out carcinogenicity studies in both mice and rats, and guidance is also given on alternative testing procedures which may be applied without jeopardizing safety.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074916.pdf


ICHS1B.pdf