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ICH E1 人群暴露程度：评价无生命威胁条件下长期治疗药物的临床安全性
ICH
ICH E1
English Version ICH E1 The Extent of Population Exposure: to Assess Clinical Safety for Drug Intended for Long-Term Treatment of Non-Life-Threatening Conditions 本指导原则的目的在于提出一套用于非危及生命性疾病长期治疗（超过6个月的慢性或间断使用）药物的安全性评估原则。在药物临床研发期间的安全性评价要求能定性和定量地描述与药物预期长期使用时间相一...
ICH E1 The Extent of Population Exposure: to Assess Clinical Safety for Drug Intended for Long-Term Treatment of Non-Life-Threatening Conditions
ICH
ICH E1
中文版 ICH E1 人群暴露程度：评价无生命威胁条件下长期治疗药物的临床安全性 The objective of this guideline is to present 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) o...