ICH E1 Population exposure: the extent of population exposure to assess clinical safety - Scientific guideline
Table of contents
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.
Keywords: Safety evaluation, long-term treatment, short term exposure, non-life threatening diseases, adverse drug events (ADEs), adverse event rate, background event rate, causality