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ICH Finalizes Guide To Cutting Down On Rat Carcinogenicity Studies

 
• By Vibha Sharma

An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.

Rodent white lab rat (pet) sitting on the table near dark bottles of medicine (liquid) in the laboratory; biotechnology, pharmacy, medicine development, tests on animals.
There Is A Greater Understanding Of The Limitations Of Rodent Models In Carcinogenicity Testing • Source: Shutterstock

The International Council for Harmonisation has updated its carcinogenicity testing guideline with new recommendations on how sponsors can apply an integrative weight of evidence (WoE) approach to assessing the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study.

The recommendations were finalized earlier this month and are published as an addendum integrated into the 1997 ICH S1B guideline on carcinogenicity testing. They encourage a more mechanism-based approach to...

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