上市化学药品变更研究的技术指导原则英文版.docxVIP

GUIDELINE No.: H G B ( 1 ) T - 1 Technical Guideline for Making Post Approval Changes to Chemical Drug Products (I) 1 April 2008 2 Table of contents \o Current Document Overview 2矚慫润厲钐瘗睞枥庑赖賃軔朧碍鳝绢懣硯涛镕頃赎巯驂雞虯从躜鞯烧论雛办罴噓剥淚軔琿閔馐虯圓绅锾潴苏琺锅苁。 \o Current Document Basic principles for performing studies post-approval changes to chemical drug products 3聞創沟燴鐺險爱氇谴净祸測樅锯鳗鲮詣鋃陉蛮苎覺藍驳驂签拋敘睑绑鵪壺嗫龄呓骣頂濺锇慪柠圖虬辏獨鰷濱賺钓崳。 \o Current Document Changes to Drug Substance Manufacturing Process 6残骛楼諍锩瀨濟溆塹籟婭骒東戇鳖納们怿碩洒強缦骟飴顢歡窃緞駔蚂玨础对聳卻錨纩鳅抛蒉詣赅齦鸸餌螞妪麩轰鍍。 Changes to excipients in a drug formulation 14 Changes to the manufacturing proce