A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association

Clin Pharmacol Ther. 2010 Aug;88(2):260-2. doi: 10.1038/clpt.2010.77. Epub 2010 Jun 30.

Authors

R K Chetty¹, J S Ozer, A Lanevschi, I Schuppe-Koistinen, D McHale, J S Pears, J Vonderscher, F D Sistare, F Dieterle

Affiliation

¹ Drug Metabolism and Pharmacokinetics, Clinical Pharmacology Unit, AstraZeneca Research and Development, Alderley Park, UK.

PMID: 20592723
DOI: 10.1038/clpt.2010.77

No abstract available

Publication types

Review

MeSH terms

Algorithms*
Biomarkers*
Causality*
Clinical Trials as Topic*
Data Interpretation, Statistical
Drug Evaluation, Preclinical / methods*
Drug Evaluation, Preclinical / statistics & numerical data
Drug-Related Side Effects and Adverse Reactions*
Humans
Reproducibility of Results
Safety
United States
United States Food and Drug Administration

Substances

Biomarkers