Implications of the Institute of Medicine Report: Evaluation of biomarkers and surrogate endpoints in chronic disease

Clinical Pharmacology and Therapeutics

Volumn 98, Issue 1, 2015, Pages 12-15

  Wagner, J A ^a   Ball, J R ^b  

^a TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^b AMERICAN COLLEGE OF PHYSICIANS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

CHRONIC DISEASE; DECISION MAKING; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL PRACTICE; PRIORITY JOURNAL; REVIEW; BIOASSAY; GOVERNMENT; ORGANIZATION; PRACTICE GUIDELINE; PROCEDURES; UNITED STATES;

BIOLOGICAL MARKERS; CHRONIC DISEASE; ENDPOINT DETERMINATION; GOVERNMENT AGENCIES; GUIDELINES AS TOPIC; HUMANS; INSTITUTE OF MEDICINE (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84940563630     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.129     Document Type: Review

References (8)

1. Institution of Medicine. In Evaluation of Biomarkers, and Surrogate Endpoints in Chronic Disease (eds. Micheel C.M, & Ball J.R.) (National Academy Press, Washington, DC, 2010).
2. The Biomarker Definitions Working Group. Biomarkers, and surrogate endpoints: preferred definitions, and conceptual framework. Clin. Pharmacol. Ther. 69, 89-95 (2001).
3. Lathia C.D, et al. The value, qualification, and regulatory use of surrogate end points in drug development. Clin. Pharmacol. Ther. 86, 32-43 (2009).
4. US Food &Drug Administration. Biomarker Qualification Program. Accessed 20 March 2015.
5. Mould D.R, & Upton R.N. Basic concepts in population modeling, simulation, and modelbased drug development. CPT Pharmacometrics Syst. Pharmacol. 1, e6 (2012).
6. Woodcock J. Assessing the clinical utility of diagnostics used in drug therapy. Clin. Pharmacol. Ther. 88, 765-773 (2010).
7. Daniel G.W, & McClellan M.B. Advancing the use of biomarkers and pharmacogenomics in drug development. Accessed 20 March 2015.
8. Policy issues in the clinical development and use of biomarkers for molecularly targeted therapies. Accessed 20 March 2015.