title: A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association.
authors.affiliation: Drug Metabolism and Pharmacokinetics, Clinical Pharmacology Unit, AstraZeneca Research and Development, Alderley Park, UK.
authors.forename: R K
authors.initials: RK
authors.lastname: Chetty
authors.forename: J S
authors.initials: JS
authors.lastname: Ozer
authors.forename: A
authors.initials: A
authors.lastname: Lanevschi
authors.forename: I
authors.initials: I
authors.lastname: Schuppe-Koistinen
authors.forename: D
authors.initials: D
authors.lastname: McHale
authors.forename: J S
authors.initials: JS
authors.lastname: Pears
authors.forename: J
authors.initials: J
authors.lastname: Vonderscher
authors.forename: F D
authors.initials: FD
authors.lastname: Sistare
authors.forename: F
authors.initials: F
authors.lastname: Dieterle
mesh_terms: D000465:Algorithms; D015415:Biomarkers; D015984:Causality; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015203:Reproducibility of Results; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers