title: Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum recommendation.
abstract: Interference testing of co-medication in bioanalytical method validation has become an area of debate in view of the increased specificity offered by current state-of-the-art technology in both LC-MS/MS and ligand-binding assay platforms. In view of this, and considering the extensive experience within the European Bioanalysis Forum member companies, we evaluated the impact of co-medication on the performance of hundreds of bioanalytical methods with the aim of providing a science-based recommendation on how to evaluate and document potential interference from co-medication on the PK parameters in clinical studies in patients and volunteers.
authors.affiliation: PRA Health Sciences, Assen, The Netherlands.
authors.forename: Marcel
authors.initials: M
authors.lastname: de Zwart
authors.affiliation: CRS Clinical Research Services, Grünstadt, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Lausecker
authors.affiliation: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
authors.forename: Susanne
authors.initials: S
authors.lastname: Globig
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Neddermann
authors.affiliation: Servier, Orléans, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Le Bras
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Alberto
authors.initials: A
authors.lastname: Guenzi
authors.affiliation: GlaxoSmithKline, Ware, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: White
authors.affiliation: Novo Nordisk A/S, Måløv, Denmark.
authors.forename: Marianne
authors.initials: M
authors.lastname: Scheel-Fjording
authors.affiliation: Janssen R&D, Turnhoutseweg, 30 B-2340, Beerse, Belgium.
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000592:standards; D004347:Drug Interactions; D006801:Humans; D008024:Ligands; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D053719:Tandem Mass Spectrometry / Q000592:standards
chemical_list: D008024:Ligands; D004364:Pharmaceutical Preparations
keywords: co-medication; interference testing; method validation