ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
| Current effective version |
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| Reference number | CPMP/ICH/378/95 |
| Published | 01/09/1998 |
| Effective from | 01/09/1998 |
| Keywords | Foreign clinical data, regulatory requirements, extrapolation, ethnic factors, bridging study, global development |
| Description | 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 with questions and answers. |
