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.
