对《日本版橙皮书——溶出一致、临床疗效一致》的解读——兼论我国口服固体制剂仿制药质量评价

Interpretations on The Clinical Equivalence Based on the Samein vitro Dissolution Behavior in Orange Book of Japan:Analysis of the Guidelines for Quality Consistent Evaluation of Domestic Generic Product with the Solid Dosage Form

日本版《橙皮书》的制订与美国版有很大不同,采用了特有的体外溶出评价手段,因为日本药监局专家组经大量案例验证得到如下结论:当仿制药体外溶出行为与原研药一致时,不仅两者体内生物利用度一致的概率将极高(即生物等效性试验可轻松通过),且临床上对于各类患者的疗效也将一致。这一认知很值得我国借鉴与效仿,现对日本版橙皮书进行介绍,并结合其对我国口服固体制剂仿制药质量评价进行讨论,以供读者参考。

The orange book in Japan is focused on the dissolution and established based on the validation of lots of cases by the experts in PMDA,which is quite different with that of FDA.The main idea is concluded as follows.A generic product has a similar bioavailability with that of the brand named product statistically,when the two products has the similar in vitro dissolution behaviors,further indicating the similar clinical effect.This idea will be helpful to understandingthe drug development.Thus the orange book in Japan translated in this article aims to provide some reference to thedomestic researchers.