Reference Standard在FDA中是什么意思?对比RLD有什么区别 - 药学...

来自 : muchong.com/html/201702/110190 发布时间：2021-03-24

A “reference standard” is the drug product selected by FDA that an applicant seeking approval ofan ANDA must use in conducting an in vivo bioequivalence study required for approval of the ANDA. To facilitate generic drug development, FDA generally selects a single referencestandard that ANDA applicants must use in any in vivo testing conducted to support a demonstration of bioequivalence. FDA selects a single reference standard to ensure the greatestlevel of consistency between a generic drug and its RLD and among generic drugs. Ordinarily,the reference standard selected by FDA will be the RLD. FDA usually selects as the reference standard the highest strength available for drug products with multiple approved strengths.
reference standard应该是作为BE必须用的参比制剂的意思（一般的reference standard就是RLD），

2017年2月4日FDA中Reference Standard和Reference Listed Drug各有什么区别? U{@U@H2D62L5W}4VFGFMBJS.png 返回小木虫查看更多分享至: 更多 今日...小木虫,小木虫论坛,论文,投稿,基金,化学,化工,材料,学术,科学,科研,博士,硕士,教育,理工,论文翻译,论文润色，期刊FDA中ReferenceStandard和ReferenceListedDrug各有什么区别？2017/0204/w336h2699634_1486173702_453.png|bcs|1U{@U@H2D62L5W}4VFGFMBJS.pngReference Standard在FDA中是什么意思？对比RLD有什么区别