Technical Requirements for Biopharmaceutics Classification System-based Biowaiver in China

被引：1
|
作者：
Zhang Ning [1 ,2 ]
Ping Qi-neng [3 ]
机构：
[1] Ctr Drug Evaluat State Food & Drug Adm, Beijing 100038, Peoples R China
[2] China Pharmaceut Univ, Coll Int Pharm & Business, Nanjing 210009, Peoples R China
[3] China Pharmaceut Univ, Coll Int Pharm & Business, Nanjing 210009, Peoples R China
来源：
DRUG INFORMATION JOURNAL | 2011年 / 45卷 / 05期
关键词：
Biopharmaceutics Classification System (BCS); Biowaiver; Oral; Immediate-release products; Technical requirements; ORAL DOSAGE FORMS; INTESTINAL TRANSIT; MONOGRAPHS;
D O I：
10.1177/009286151104500612
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
Since its inception in 1995, the Biopharmaceutics Classification System (BCS) has become an increasingly important tool for regulation of drug product development worldwide. The regulations with respect to biowaivers for immediate-release solid oral dosage forms in the United States, the EU, and from the World Health Organization are summarized and compared in this article. On this basis, technical requirements for BCS-based biowaiver in China are proposed, and biowaiver eligibility of immediate-release oral products in the China Pharmacopoeia 2005, and the top 200 best sale list in 2008 are evaluated, which shows a similar trend to those found in the top 200 lists,from the United States and Great Britain.
引用
收藏
页码：619 / 625
页数：7
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