生物等效性研究是评价药物制剂质量的重要手段,不仅可以用于仿制药申请上市批准的过程中,同时在新药开发、新药生产工艺和剂型变换的过程中,也发挥着非常重要的作用。药代动力学研究方法是目前比较常用的生物等效性评价方法。在此方法中,药时曲线下面积是生物等效性评价的重 Bioequivalence study is an important means to evaluate the quality of pharmaceutical preparations. It can not only be used in the process of listing and approving generic drugs, but also play an important role in the process of new drug development, new drug production process and dosage form conversion. Pharmacokinetic research methods are currently more commonly used bioequivalence evaluation method. In this method, the area under the curve of the pharmacokinetics is the weight of the bioequivalence assessment