ICH E1 Population exposure: the extent of population exposure to assess clinical safety
Current effective version |
|
Reference number | CPMP/ICH/375/95 |
Published | 01/06/1995 |
Effective from | 01/06/1995 |
Keywords | Safety evaluation, long-term treatment, short term exposure, non-life threatening diseases, adverse drug events (ADEs), adverse event rate, background event rate, causality |
Description | This document presents an accepted set of principles for the safety evaluation of drugs intended for the long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening diseases. |