基于生物药剂学分类系统（BCS）的生物等效性豁免旨在减少对体内生物等效性研究的需求，即可以提供一种体内生物等效性的替代方法。基于BCS分类的生物等效性豁免需提供药物的溶解性、渗透性和体外溶出数据。主要论述药物溶解性、渗透性和体外溶出度测定的方法，希望建立药物相关特性的标准化、规范化测定流程，以保证企业在申报生物等效性豁免时，所提供的数据是准确、可靠的。

The BCS (Biopharmaceutics Classification System)-based biowaiver approach is meant to reduce in vivo bioequivalence studies. It may represent a surrogate for in vivo bioequivalence. When combined with the dissolution of the drug product, the BCS takes into account three major factors that govern the rate and extent of drug absorption from IR solid oral dosage forms: dissolution, solubility, and intestinal permeability. In this article, the test methods of solubility, intestinal permeability and dissolution of the drugs applied for biowaiver are recommended to establish a series of standard methods for ensuring the accuracy and reliability of data.

R945

“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）