Reclassification of the main impurity (-)-scopolamine hydrobromide trihydrate in scopolamine butylbromide: an integrated ICH M7 guideline assessment combining in silico, in vitro, and in vivo studies
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Following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) multidisciplinary guideline M7 (R2), in silico prediction, in vitro and in vivo genotoxicity evaluations were used to evaluate the potential... ...
