Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.
Authors and Affiliations
Eric Fluhler, Faye Vazvaei, Puran Singhal, Petra Vinck, Wenkui Li, Jignesh Bhatt, Theo de Boer, Ajai Chaudhary, Masahiro Tangiuchi, Vinicius Rezende, Dafang Zhong
Keywords
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- EP ID EP681724
- DOI 10.1208/s12248-014-9644-1
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