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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceutica
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Document Date: 2012-06-22 05:08:09

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City

Aberdeen / San Francisco / Preston / Plymouth / /

Company

Expert Working Group / J.T. MacGregor / Mutat / Suzuki / Environ / FOR REGISTRATION OF PHARMACEUTICALS / /

Country

United Kingdom / Scotland / /

Event

FDA Phase / /

Facility

International Life Sciences Institute / D.G. Gatehouse / Environmental Sciences Institute / /

IndustryTerm

pharmaceutical industry / gene mutation assay protocol / in vitro micronucleus assay working / /

MedicalCondition

lymphoma thymidine kinase locus gene mutation assay / lymphoma thymidine kinase gene mutation assay / /

MusicGroup

I.B. / /

Organization

ICH committee / Health and Environmental Sciences Institute / US Food and Drug Administration / European Centre for the Validation of Alternative Methods / FDA / International Life Sciences Institute / /

Person

L.F. Stankowski Jr. / M. Ishidate Jr. / E. Parry / V / S.E. Boucher / F. Van Goethem / G. Speit / V / /

Position

Singer / /

Product

R1 / Lambert / ICHS2 / S2A / /

Technology

lymphoma TK gene mutation assay protocol / cell assays / drug development / /

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