ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline
Table of contents
Guidance on approaches for evaluating the carcinogenic potential of pharmaceuticals. It embraces all pharmaceutical agents that need carcinogenicity testing as indicated in the ICH S1A.
Keywords: Carcinogenic potential, long-term carcinogenicity study, rodent carcinogenicity studies, short or medium-term carcinogenity test, mechanistic studies, choice of species
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ICH: S 1 B: Testing for carcinogenicity of pharmaceuticals - Step 5 (PDF/163.99 KB)
Adopted
First published: 30/09/1997
Last updated: 30/09/1997
Legal effective date: 01/03/1998
CPMP/ICH/299/95 -
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Overview of comments received on Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals (EMA/CHMP/ICH/272147/2021) (PDF/147.54 KB)
First published: 11/11/2021
EMA/628493/2021 -
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Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - Step 2b (PDF/522.43 KB)
Draft: consultation closed
First published: 20/05/2021
Consultation dates: 22/04/2021 to 22/10/2021
EMA/CHMP/ICH/272147/2021