A roadmap for biomarker qualification

Nature Biotechnology

Volumn 28, Issue 5, 2010, Pages 444-445

  Warnock, David G ^a   Peck, Carl C ^b  

^a University of Alabama at Birmingham   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; KIDNEY INJURY; NEPHROTOXICITY; NOTE; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC;

ANIMALS; BIOMARKERS, PHARMACOLOGICAL; HUMANS; KIDNEY; PHARMACEUTICAL PREPARATIONS; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77952139337     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt0510-444     Document Type: Note

References (12)

1. Dieterle, F. et al. Nat Biotechnol. 28, 463-469 (2010).
2. Yu, Y. et al. Nat. Biotechnol. 28, 470-477 (2010).
3. Vaidya, V.S. et al. Nat. Biotechnol. 28, 478-485 (2010).
4. Ozer, J.S. et al. Nat. Biotechnol. 28, 486-494 (2010).
5. Sistare, F.D. et al. Nat. Biotechnol. 28, 446-454 (2010).
6. Dieterle, F. et al. Nat. Biotechnol. 28, 455-462 (2010).
7. http://www.fda.gov/oc/initiatives/criticalpath/projectsum mary/consortium.html
8. http://www.fda.gov/oc/initiatives/criticalpath/
9. Bonventre, J.V. et al. Nat. Biotechnol. 28, 436-440 (2010).
10. Hanley, J.A. & NcNeil, B.J. Radiology 143, 29-36 (1982).
11. The Food and Drug Administration Biomarker Qualification Review Team. Review of Qualification Data for Biomarkers of Nephrotoxicity Submitted by the Predictive Safety Testing Consortium (FDA CDER, 21 February 2008).
12. EMEA. Biomarkers Qualification: Guidance to Applicants (doc. ref. EMEA/CHMP/SAWP/72894/2008-CONSULTATION, 24 April 2008).