Quality by design: Concepts for ANDAs

被引：215

作者：

Lionberger, Robert A. ^{[1
]}

Lee, Sau Lawrence ^{[1
]}

Lee, LaiMing ^{[1
]}

Raw, Andre ^{[1
]}

Yu, Lawrence X. ^{[1
]}

机构：

[1] US FDA, Off Gener Drugs, Rockville, MD 20855 USA

来源：

AAPS JOURNAL | 2008年 / 10卷 / 02期

关键词：

control strategy; critical material attributes; critical process parameters; design space; quality by design;

D O I：

10.1208/s12248-008-9026-7

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. Agreement on these key concepts will allow discussion of the application of these concepts to abbreviated new drug applications to progress.

引用

页码：268 / 276

页数：9