Spring Intro 2023

22/03/2023

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When are Carcinogenicity Studies Needed? new guidance 2022 - a WOE assessment [ICH S1A, S1BR1, S1CR2]

1. substance in clinical use continuously for long periods (i.e. > 6 months) or frequent intermittent use i.e. treatment of chronic illness 2. chemical structure suggests carcinogenic potential (by reference to other carcinogens) 3. or, concern because: - several members therapeutic class have been carcinogenic - long-term retention in previous studies - genotoxicity/short term carcinogenicity tests +ve If so, tests may be needed before some trials commence. Conversely, for a serious indication, carcinogenicity studies may be completed post-approval.

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