[关键词]
[摘要]
在仿制药研究过程中通过体外评价方法替代体内生物等效性研究可以减少临床资源消耗,加快药品上市进度,这是基于生物药剂学分类系统(BCS)的生物等效性豁免的主要原因。随着我国仿制药的快速发展,企业基于BCS的生物豁免申请需求越来越迫切,当药物制剂为具有全身作用的普通口服制剂,且药物活性成分符合溶解性和渗透性(BCS I和III类)标准,受试制剂剂型和规格与参比制剂相同,可适用基于BCS的生物等效性豁免。对国内外的基于BCS分类的生物豁免研究进展和法规进行综述,并对具体操作及申报要求提出一些思考。
[Key word]
[Abstract]
The purpose of biowaiver based on biopharmaceutical classification system (BCS) is to replace in vivo bioequivalence study by in vitro evaluation method, which can reduce the consumption of clinical resources and accelerate the progress of drug marketing. With the rapid development of generic drugs in China, there is an increasingly demand for sponsors to apply for biowaiver based on BCS classification. The biowaiver based on BCS is applicable if the active ingredients of the drug meet the solubility and permeability (BCSI and III) standards, and the drug preparation is a general oral preparation with systemic effect, and the dosage form and specification of the test preparation are the same as the reference preparation. This paper summarizes the research progress and regulations of biowaiver based on BCS classification at home and abroad, and puts forward some thoughts on the specific operation and application requirements.
[中图分类号]
R945
[基金项目]
“重大新药创制”国家科技重大专项(2017ZX09101001);基于BCS分类及体内外相关性的生物豁免研究(2017ZX0901001-004)