How to manage having no incurred sample reanalysis evaluation failures

被引:2
|
作者
Garofolo, Fabio [1 ]
Bergeron, Annik [1 ]
Savoie, Natasha [1 ]
机构
[1] Algorithme Pharma Inc, Montreal, PQ H7V 4B3, Canada
关键词
acyl glucuronides; advanced method development; bioanalytical guidelines; ISR; ISR criteria; ISR failure; unstable metabolites; US FDA; White Paper in bioanalysis; BIOANALYTICAL METHOD DEVELOPMENT; VALIDATION GROUP WORKSHOP; REGULATED BIOANALYSIS; RECENT ISSUES; WHITE PAPER; CALIBRATION;
D O I
10.4155/BIO.11.22
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
...our determination to develop a robust, scientifically sound and high-quality method, as well as our employees' professionalism and our quality system, keep us away from incurred sample reanalysis failures.
引用
收藏
页码:935 / 938
页数:4
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