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Wednesday, November 3, 2010

ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)

 ICH topics are divided in to 4 major types:

1. "Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.)

 2."Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.)

3."Efficacy" Topics, i.e., those relating to clinical studies in human subject (Dose Response Studies, Good Clinical Practices, etc.)

4."Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5)

 Source: https://www.ich.org/cache/html/250-272-1.html

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