title: A generic operational strategy to qualify translational safety biomarkers.
abstract: The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.
authors.affiliation: Boehringer-Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Matheis
authors.forename: David
authors.initials: D
authors.lastname: Laurie
authors.forename: Christiane
authors.initials: C
authors.lastname: Andriamandroso
authors.forename: Nadir
authors.initials: N
authors.lastname: Arber
authors.forename: Lina
authors.initials: L
authors.lastname: Badimon
authors.forename: Xavier
authors.initials: X
authors.lastname: Benain
authors.forename: Kaïdre
authors.initials: K
authors.lastname: Bendjama
authors.forename: Isabelle
authors.initials: I
authors.lastname: Clavier
authors.forename: Peter
authors.initials: P
authors.lastname: Colman
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Firat
authors.forename: Jens
authors.initials: J
authors.lastname: Goepfert
authors.forename: Steve
authors.initials: S
authors.lastname: Hall
authors.forename: Thomas
authors.initials: T
authors.lastname: Joos
authors.forename: Sarah
authors.initials: S
authors.lastname: Kraus
authors.forename: Axel
authors.initials: A
authors.lastname: Kretschmer
authors.forename: Michael
authors.initials: M
authors.lastname: Merz
authors.forename: Teresa
authors.initials: T
authors.lastname: Padro
authors.forename: Hannes
authors.initials: H
authors.lastname: Planatscher
authors.forename: Annamaria
authors.initials: A
authors.lastname: Rossi
authors.forename: Nicole
authors.initials: N
authors.lastname: Schneiderhan-Marra
authors.forename: Ina
authors.initials: I
authors.lastname: Schuppe-Koistinen
authors.forename: Peter
authors.initials: P
authors.lastname: Thomann
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Vidal
authors.forename: Béatrice
authors.initials: B
authors.lastname: Molac
mesh_terms: D000818:Animals; D054316:Biomarkers, Pharmacological / Q000378:metabolism*; D002986:Clinical Trials as Topic / Q000379:methods*; D015195:Drug Design; D064420:Drug-Related Side Effects and Adverse Reactions; D023381:Endpoint Determination; D017408:Guidelines as Topic; D006801:Humans; D012107:Research Design
chemical_list: D054316:Biomarkers, Pharmacological