基于药物体内处置的生物药剂学分类系统(BDDCS)简介

Introduction to biopharmaceutics drug disposition classification system (BDDCS)

基于药物体内处置的生物药剂学分类系统将目前FDA现行的生物药剂学分类系统作以改进,使用药物体内代谢程度作为渗透性的替代指标,对药物进行分类。该系统不但可以补充现有仿制药物生物等效性豁免的评审标准,还可以对药物在体内的各种特征进行预测。本文将对该系统作以详细的介绍,在此基础上着重探讨药物转运体在药物体内分布中的作用。

Biopharmaceutics drug disposition classification system （BDDCS） is a modified system based on current FDA biopharmaceutics classification system, using metabolism as a surrogate indicator for absorption, to classify highly permeable drugs. BDDCS could not only be a supplement to the FDA＇ s biowaiver criteria for the generic drugs, but could also make predictions of drug in vivo profiles. In this review, we will make detailed introduction to the BDDCS system, and drug transporters involved in drug disposition.