中国他达拉非片生物等效性试验研究现状及其审评要求

他达拉非片用于治疗男性勃起功能障碍及改善勃起功能障碍合并良性前列腺增生的症状和体征，属临床常用药物，也是原研药品专利到期后多家企业立项仿制的重点关注品种之一。结合欧盟、美国该品种生物等效性试验指导原则要求，通过对近年来中国开展的他达拉非片生物等效性试验结果进行总结、分析，并对其生物等效性试验审评中发现的多种情况提出一般考虑，为他达拉非片仿制药研发中的生物等效性试验提供依据与参考。

Progress and review requirement for Tadalafil Tablet bioequivalence test in China

Tadalafil Tablet is used for the treatment of male erectile dysfunction, Erectile Dysfunction combined with symptoms and signs of benign prostatic hyperplasia, which is a common drug in clinic. It is also one of the key drugs which enterprises set up project after the expiration of the original drug patent. Combining with the European Union, the United States tadalafil tablet bioequivalence test guidelines require, summary and analysis based on recent years bioequivalence result in China, and propose general consideration on variety bioequivalence results of review. For tadalafil tablet bioequivalence research and development provid scientific basis and reference.