ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - Scientific guideline
Table of contents
This document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together withICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers - Scientific guideline.
Keywords: Foreign clinical data, regulatory requirements, extrapolation, ethnic factors, bridging study, global development