A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association.
Chetty
R K
RK
Drug Metabolism and Pharmacokinetics, Clinical Pharmacology Unit, AstraZeneca Research and Development, Alderley Park, UK.
Ozer
J S
JS
Lanevschi
A
A
Schuppe-Koistinen
I
I
McHale
D
D
Pears
J S
JS
Vonderscher
J
J
Sistare
F D
FD
Dieterle
F
F
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
D015415:Biomarkers