| Literature DB >> 21083073 |
Philip Timmerman1, Silke Luedtke, Peter van Amsterdam, Margarete Brudny-Kloeppel, Berthold Lausecker, Stephanie Fischmann, Susanne Globig, Carl-Johan Sennbro, Josep M Jansat, Hans Mulder, Elizabeth Thomas, Magnus Knutsson, Dirk Kasel, Stephen A White, Morten Anders Kall, Nathalie Mokrzycki-Issartel, Achim Freisleben, Fernando Romero, Michael Pilgård Andersen, Norbert Knebel, Marcel de Zwart, Sirpa Laakso, Richard S Hucker, Dietmar Schmidt, Ben Gordon, Richard Abbott, Pierre Boulanger.
Abstract
Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed. The ultimate goal of the EBF recommendation is to ensure that bioanalytical methods can provide accurate and reproducible concentration data for pharmacokinetic and/or toxicokinetic evaluation, without any compromise, while safeguarding the optimal use of laboratory resources.Mesh：
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Year: 2009 PMID： 21083073 DOI： 10.4155/bio.09.108
Source DB: PubMed Journal: Bioanalysis ISSN： 1757-6180 Impact factor: 2.681