What ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals requires
ICH S6(R1) establishes the framework for preclinical safety assessment of biologics including monoclonal antibodies, recombinant proteins, and gene therapies, requiring pharmacologically relevant species selection, integrated immunogenicity monitoring, tissue cross-reactivity studies, and risk-based determination of carcinogenicity and genotoxicity study requirements.
Pillar: Biotech & Genomics · Authority: ICH Safety Working Party (SWP) - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.1.0 · Last updated:
Primary source: https://www.ich.org/products/guidelines/safety/safety-single/article/s6.html
SHA-256 integrity: 9217e6af38b85e98e459dccbd4ec284b7ab164b20094a342b8a296f53cf21ee9
Primary Citations — 7 traced to source
- ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals - Addendum to ICH S6
- ICH S6(R1) Full Guideline Text - Step 4 Final Document
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