Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum

被引：16
|
作者：
Kall, Morten Anders [1 ]
Michi, Marco [2 ]
van der Strate, Barry [3 ]
Freisleben, Achim [4 ]
Stoellner, Daniela [5 ]
Timmerman, Philip [6 ]
机构：
[1] H Lundbeck & Co AS, Copenhagen, Denmark
[2] Aptuit, Verona, Italy
[3] PRA Hlth Sci, Assen, Netherlands
[4] Nuvisan GmbH, Grafing, Germany
[5] Novartis Inst BioMed Res, Basel, Switzerland
[6] European Bioanal Forum, Brussels, Belgium
来源：
BIOANALYSIS | 2018年 / 10卷 / 21期
关键词：
European Bioanalysis Forum; incurred sample reanalysis; incurredsample reproducibility; VALIDATION; IMPLEMENTATION; REANALYSIS;
D O I：
10.4155/bio-2018-0194
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach - among others?
引用
收藏
页码：1723 / 1732
页数：10
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