Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative

被引：138
|
作者：
Hinz, DC [1 ]
机构：
[1] Schering AG, Proc Control Dept, Global CMC Dev, D-13342 Berlin, Germany
来源：
ANALYTICAL AND BIOANALYTICAL CHEMISTRY | 2006年 / 384卷 / 05期
关键词：
Drug products plants;
D O I：
10.1007/s00216-005-3394-y
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
The initiative taken by the FDA on the use of process analytical technologies (PAT) in the pharmaceutical industry is discussed. Analytical tools have evolved to such an extent that they are capable of dealing with the complex matrix of multiple dosage forms and of providing data in meaningful way. In the process, near-infrared spectroscopy (NIR), radio frequency, and microwaves have been applied for moisture determination. The first PAT team will, continue its training, and a second PAT team will be selected to begin training for CMC review and cGMP inspections of applications that utilize PAT.
引用
收藏
页码：1036 / 1042
页数：7
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