生物等效性评价及相关问题

Bioequivalence studies and related problems

生物等效性在新药研究、非专利药开发和药品上市后评价中具有重要作用。本文从实验方法学、药剂因素、内源性物质、活性代谢物、立体异构药物和高变异性药物等方面对生物等效性研究在技术指南及实际应用中需要特别注意的问题进行了具体论述,同时对生物药剂学分类系统等生物等效性研究的相关进展做了初步介绍。

Bioequivalence study plays a key role in drug development including new drug products non- patent generic equivalents, and those after available on market. Some specific problems, such as experimental method, pharmaceutical factors, endogenous substances, active metabolite, isomerizes and high variability, in bioequivalence study and related progress of technic guidance with proctical application were discussed, and biopharmaceutics classification system dealing with bioequivalence was also recommended in this paper.