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Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived - PharmaFacts
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Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived

Guidances - FDA Guidances

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.

This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3Rs (reduce/refine/replace) principles and reduce the use of other drug development resources. Although not discussed in this guidance, consideration should be given to use of new in vitro alternative methods for safety evaluation. These methods, if validated and accepted by all ICH regulatory authorities, can be used to replace current standard methods.

This guidance promotes safe and ethical development and availability of new pharmaceuticals.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf