摘要
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.
作者
谢沐风
XIE Mu-feng(Shanghai food and Drug Inspection Institute, Shanghai 201203, China)
出处
《药品评价》
CAS
2017年第4期18-21,58,共5页
Drug Evaluation
关键词
口服固体制剂
仿制药
溶出度试验
体内生物利用度
生物等效性试验
橙皮书
临床疗效
药品品质再评价工程
仿制药质
Solid Dosage Form
Generic Product
Dissolution
In Vivo Bioavailability
Bioequivalence Study
Orange Book
Clinical Effect
Reevaluation of Generic Products
Quality and Efficacy Consistency Evaluation of Generic Products