ICH E1 Population exposure: the extent of population exposure to assess clinical safety

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/375/95
Effective from01/06/1995
KeywordsSafety evaluation, long-term treatment, short term exposure, non-life threatening diseases, adverse drug events (ADEs), adverse event rate, background event rate, causality
DescriptionThis 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.


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