基于生物藥劑學(xué)分類(lèi)系統(tǒng)（BCS）的生物等效性豁免旨在減少對(duì)體內(nèi)生物等效性研究的需求，即可以提供一種體內(nèi)生物等效性的替代方法?；贐CS分類(lèi)的生物等效性豁免需提供藥物的溶解性、滲透性和體外溶出數(shù)據(jù)。主要論述藥物溶解性、滲透性和體外溶出度測(cè)定的方法，希望建立藥物相關(guān)特性的標(biāo)準(zhǔn)化、規(guī)范化測(cè)定流程，以保證企業(yè)在申報(bào)生物等效性豁免時(shí)，所提供的數(shù)據(jù)是準(zhǔn)確、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

“重大新藥創(chuàng)制”國(guó)家科技重大專(zhuān)項(xiàng)（2017ZX09101001）：基于BCS分類(lèi)及體內(nèi)外相關(guān)性的生物豁免研究（2017ZX0901001-004）