Guideline for Industry. The Extent of Population Exposure to Assess ClinicalSafety: For Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

摘要

The objective of this guidance is to present an accepted set of principles forthe 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. The safety evaluation during clinical drug development is expected to characterize and quantify the safety profile of a drug over a reasonable duration of time consistent with the intended long-term use of the drug. Thus, duration of drug exposure and its relationship to both time and magnitude of occurrence of adverse events are important considerations in determining the size of the data base necessary to achieve such goals.