Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum

• Published in: Bioanalysis Vol. 1; no. 6; p. 1049
• Main Authors: Timmerman, Philip, Luedtke, Silke, van Amsterdam, Peter, Brudny-Kloeppel, Margarete, Lausecker, Berthold, Fischmann, Stephanie, Globig, Susanne, Sennbro, Carl-Johan, Jansat, Josep M, Mulder, Hans, Thomas, Elizabeth, Knutsson, Magnus, Kasel, Dirk, White, Stephen A, Kall, Morten Anders, Mokrzycki-Issartel, Nathalie, Freisleben, Achim, Romero, Fernando, Andersen, Michael Pilgård, Knebel, Norbert, de Zwart, Marcel, Laakso, Sirpa, Hucker, Richard S, Schmidt, Dietmar, Gordon, Ben, Abbott, Richard, Boulanger, Pierre
• Format: Journal Article
• Language: English
• Published: England 01.09.2009
• Subjects: Analytic Sample Preparation Methods - standards; Europe; Guidelines as Topic; Humans; Pharmaceutical Preparations - analysis; Pharmacokinetics; Reproducibility of Results; United States; United States; Europe
• ISSN: 1757-6199
• DOI: 10.4155/bio.09.108

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.