Genotoxicity

Definition:

Genotoxicity refers to any deleterious change in the genetic material within a cell.

Genotoxicity in vitro and in vivo tests are designed to detect compounds that induce genetic damage by various mechanisms.

Basic genotoxicity tests:

Bacterial reverse gene mutation test (Ames test)
Genotoxicity evaluated in mammalian cells in vitro and/or in vivo

More information:

Scientific guidelines on non-clinical toxicology (EMA, 2020)

Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)

S2(R1): Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (Health Canada, 2016)

FDA guidance: Bacterial reverse mutation test (FDA, 2018)

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Definition, Encyclopaedia, Publication, Webinar, Discovery, Hit-to-lead, Preclinical development, Regulatory, Toxicology