What Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk requires
This regulation requires pharmaceutical manufacturers to assess and control DNA reactive (mutagenic)…
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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/multidisciplinary-guidelines
SHA-256 integrity: e5fbdf0c25f49b8671bff768b031326eb4079b77fd7bc7b16223dc4e05bdb76a
Primary Citations — 10 traced to source
- ICH M7(R1), Section 1 - Introduction
- ICH M7(R1), Section 2 - Mutagenic Impurity Assessment
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- Discovery (free): /api/v1/nodes/ich-m7-r1-mutagenic-impurities-2017.json — 6-field metadata
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- Canonical URL: https://bidda.com/intelligence/ich-m7-r1-mutagenic-impurities-2017
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