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S1A - PharmaFacts
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S1A

Guidances - ICH Guidances

S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals:

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This document provides a consistent definition of the circumstances under which it is necessary to undertake carcinogenicity studies on new drugs. These recommendations take into account the known risk factors as well as the intended indications and duration of exposure.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074911.pdf
ICHS1A.pdf