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S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry
S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Carcinogenicity Tests -- standards
Drug Evaluation, Preclinical
Government Regulation
United States
United States. Food and Drug Administration - Genre(s):
- Guideline
Technical Report - Abstract:
- This Addendum is to be used in close conjunction with the ICH guidances for industry S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals (March 1996), S1B Testing for Carcinogenicity of Pharmaceuticals (July 1997), and S1C(R2) Dose Selection for Carcinogenicity Studies (September 2008). The Addendum is complementary to the ICH S1 guidances for industry. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in ICH S1A. For biotechnology-derived pharmaceuticals, refer to the ICH guidance for industry S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012)). This Addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original ICH S1B. This is an integrative approach that provides specific weight of evidence (WoE) criteria that inform whether a 2-year rat study is likely to add value to a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high-dose selection in ICH S1C(R2) still apply. Application of this integrative approach reduces the use of animals in accordance with the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (17 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918504487506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918504487506676