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S9 - PharmaFacts
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Guidances - ICH Guidances

S9: Nonclinical Evaluation for Anticancer Pharmaceuticals

The Guideline reached Step 4 of the ICH process on 29 October 2009.  This guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. It describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.