Advance of drug genotoxicity
HUANG Fang-hua
WANG Qing-li
Abstract：Genotoxicity study is one main components of nonclinical safety evaluation for drugs. Recently, the International Conference on Harmonization of the technical requirements for registration of pharmaceuticals for human use(ICH) revised the guidance for genotoxicity study, and released the ICH S2(R1) guidance on genotoxicity determination and data interpretation for pharmaceuticals intended for human use(Draft) in 2008. The article presented the scientific background of the revision and the major changes in the guidance S2(R1), and discussed several points concerned for genotoxieity study for drugs in China.
Keywords：genotoxicity studynonclinical safety evaluationInternational Conference on Harmonization of the technical requirements for registration of pharmaceuticals for human use(ICH)
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 468-472 )