摘要
根据FDA和CFDA口服固体制剂溶出度试验技术指导原则的要求,为防止仿制药一致性评价过程中相似因子(f2)法的滥用和不恰当应用,采用样本数据实例演示的方式说明多变量置信区间法和模型依赖法作为补充手段在溶出曲线相似性比较和BE风险预评估中的重要性。
In order to avoid excessive and inappropriate use of similarity factor （f2） in therapeutic equivalence evaluation of generic drugs and based on FDA and CFDA guide[ines for the dissolution test of oral solid dosage forms, a set of sample data was used as an example to illustrate the importance of multivariate confidence interval method and model dependent method as complementary tools in the similarity comparison of dissolution profiles and pre-assessment of BE risk.
作者
张海龙
严全鸿
朱海健
潘卫三
梁超峰
王霆
ZHANG Hailong YAN Quanhong ZHU Haijian PAN Weisan LIANG Chaofeng WANG Ting(Shenzhen Youpuhui Pharmaceutical Co., Ltd., Shenzhen 518173, China Society Jbr Pharmaceutical Engineering, Guangdong Pharmaceutical Association, Guangzhou 510632, China Guangdong Institute for Drug Control, Guangzhou 510180, China LS Pharmaceuticals （Xiamen） Co. Ltd., Xiamen 361027, China Guangzhou Union for Industry-University-Research Cooperation in Technology Innovation of Industry Controlled Correspondenee Related to Generic Drug Development, Guangzhou 510665, China Shenyang Pharmaceutical University, Shenyang 110015. China Guangzhou General Pharmaceutical Research Institute, Guangzhou 510240, China Guangzhou Yipinhong Pharmaceutical Co., Ltd., Guangzhou 510760, China)
出处
《药学进展》
CAS
2016年第12期916-923,共8页
Progress in Pharmaceutical Sciences
关键词
相似因子
溶出曲线
置信区间法
模型依赖法
similarity factor
dissolution profile
multivariate confidence interval method
model dependent method
