ICH E1 Clinical Safety for Drugs used in Long-Term Treatment

Sathyanarayana M.Sc.
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E1 Clinical Safety for Drugs used in Long-Term Treatment

E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions


The ICH harmonised Guideline was finalized under Step 4 in October 1994. This document gives recommendations on the numbers of patients and duration of exposure for the safety evaluation of drugs intended for the long-term treatment of non-life-threatening conditions.

Date of Step 4: 27 October 1994

Status: Step 5

Guidelines (Click the links below for complete guidelines)



*These Guidelines Belongs to ICH website.

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