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Genetic Toxicology: Standard Regulatory Genetic Toxicology Tests

STANDARD REGULATORY GENETIC TOXICOLOGY TESTS

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), has issued the Guidelines S2 (R1) on Genotoxicity Testing and Data Interpretation for pharmaceuticals Intended for Human Use. The following two battery options are acceptable according to the guidelines:

ICH S2R1
Test Category Test Battery 1 Test Battery 2
Bacterial Reverse Mutation Test (Example: Ames Assay) 1 assay 1 assay
In Vitro DNA Damage in Mammalian Cells (Example: In Vitro Choromosome Aberration Assay, Mouse Lymphoma Assay, In Vitro Micronucleus Assay) 1 assay none
In Vivo Test for Genetic Damage (Example: In Vivo Chromosome Aberration Assay, In Vivo Micronucleus Test) 1 assay 2 assays using different organs

Nucro-Technics can offer the following genetic toxicology tests to complete your regulatory test battery:

BACTERIAL REVERSE MUTATION TEST

IN VITRO DNA DAMAGE IN MAMMALIAN CELLS

IN VIVO TEST FOR GENETIC DAMAGE

For further information about these services, to receive a quotation, or to schedule a test, please contact NUCRO-TECHNICS.