Transcription of S2 (R1) Step 5 Genotoxicity testing and data ...
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S2 (R1) Step 5 Genotoxicity testing and data ...
June 2012 EMA/CHMP/ICH/126642/2008 ICH guideline S2 (R1) on Genotoxicity testing and data interpretation for pharmaceuticals intended for human use Step 5 Transmission to CHMP March 2008 Adoption by CHMP for release for consultation March 2008 End of consultation (deadline for comments) May 2008 Final adoption by CHMP December 2011 Date for coming into effect June 2012 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2013.
metaphase chromosome aberration test or . in vitro. micronucleus test), or an . in vitro . mouse lymphoma . Tk. gene mutation assay. iii. An . in vivo. test for genotoxicity, generally a test for chromosomal damage using rodent hematopoietic cells, either for micronuclei or for chromosomal aberrations in metaphase cells.
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