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S1C(R2) - PharmaFacts
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Guidances - ICH Guidances

S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals and Limit Dose:

This second revision has been approved by the ICH Steering Committee directly under Step 4 without further public consultation in March 2008. Note 2 of the parent guideline has been deleted, and the text referring to the Notes has been revised. The title has been changed by deleting "& Limit Dose". The Addendum has been integrated in the text. This document addresses the criteria for the selection of the high dose to be used in carcinogenicity studies on new therapeutic agents to harmonise current practices and improve the design of studies. In this revision, the pharmacokinetic endpoint of 25 is declared to be applicable also for pharmaceuticals with positive genotoxicity signals. This change has implications on "Refinement" (one of the 3R's) in enhancing the welfare, i.e., reducing the pain or discomfort of the animals at the MTD.