title: Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum.
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.
authors.affiliation: Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium. ptimmerm@its.jnj.com
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
authors.forename: Silke
authors.initials: S
authors.lastname: Luedtke
authors.forename: Peter
authors.initials: P
authors.lastname: van Amsterdam
authors.forename: Margarete
authors.initials: M
authors.lastname: Brudny-Kloeppel
authors.forename: Berthold
authors.initials: B
authors.lastname: Lausecker
authors.forename: Stephanie
authors.initials: S
authors.lastname: Fischmann
authors.forename: Susanne
authors.initials: S
authors.lastname: Globig
authors.forename: Carl-Johan
authors.initials: CJ
authors.lastname: Sennbro
authors.forename: Josep M
authors.initials: JM
authors.lastname: Jansat
authors.forename: Hans
authors.initials: H
authors.lastname: Mulder
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Thomas
authors.forename: Magnus
authors.initials: M
authors.lastname: Knutsson
authors.forename: Dirk
authors.initials: D
authors.lastname: Kasel
authors.forename: Stephen A
authors.initials: SA
authors.lastname: White
authors.forename: Morten Anders
authors.initials: MA
authors.lastname: Kall
authors.forename: Nathalie
authors.initials: N
authors.lastname: Mokrzycki-Issartel
authors.forename: Achim
authors.initials: A
authors.lastname: Freisleben
authors.forename: Fernando
authors.initials: F
authors.lastname: Romero
authors.forename: Michael Pilgård
authors.initials: MP
authors.lastname: Andersen
authors.forename: Norbert
authors.initials: N
authors.lastname: Knebel
authors.forename: Marcel
authors.initials: M
authors.lastname: de Zwart
authors.forename: Sirpa
authors.initials: S
authors.lastname: Laakso
authors.forename: Richard S
authors.initials: RS
authors.lastname: Hucker
authors.forename: Dietmar
authors.initials: D
authors.lastname: Schmidt
authors.forename: Ben
authors.initials: B
authors.lastname: Gordon
authors.forename: Richard
authors.initials: R
authors.lastname: Abbott
authors.forename: Pierre
authors.initials: P
authors.lastname: Boulanger
mesh_terms: D053000:Analytic Sample Preparation Methods / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations