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Genetic Toxicology Across Drug Discovery & Development
A complete genetic toxicology roadmap from target identification to clinical phases — from miniaturised discovery screens through the GLP OECD battery (471, 476, 487, 490, 473) and ICH M7 impurity management.
What's inside
- Genetic toxicology mapped across discovery to clinical phases
- Miniaturised discovery screens (low material, fast turnaround)
- IND-enabling GLP battery: OECD 471, 476, 487, 490, 473
- Genotoxic Impurity (GTI) management under ICH M7
- Nitrosamine-specific Enhanced Ames and Mouse Lymphoma assays
GenEvolutioN supports genetic toxicology across the full drug discovery and development continuum — from target identification and hit-to-lead through pre-clinical development and clinical phases.
Discovery & lead optimisation: miniaturised, low-material screens such as Ames MPF 384-well, MNT 24-well + FISH, CTA 96-well and HPRT to flag liabilities early.
IND-enabling & regulatory: the GLP battery under OECD 471 (Ames), 476 (HPRT), 490 (MLA), 487 (MN + FISH) and 473 (HLCA), including Ames testing for the management of Genotoxic Impurities (GTIs) under ICH M7, and Enhanced Ames / Mouse Lymphoma assays for nitrosamines.
Who this is for
- Pharmaceutical and biotech R&D and tox teams
- Programme leads planning a genetic tox strategy
- Regulatory affairs and CMC professionals
Recommended citation
GenEvolutioN Scientific Team (2025). Genetic Toxicology Across Drug Discovery & Development. GenEvolutioN Technologies.