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S6(R1) - PharmaFacts
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Guidances - ICH Guidances

S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals:

This guideline has been released for consultation under Step 2 of the ICH process on 29 October 2009.  This guidance replaces the S6 Guideline. The purpose of the addendum is to provide clarification on and an update of the following topics discussed in the original ICH S6 guidance: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. Scientific advances and experience gained since publication of the original ICH S6 guidance call for this addendum.
This harmonised addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.


ICH S6 Addendum (PDF)