Qualifying biomarkers for use in drug development: A US Food and Drug Administration overview

Expert Opinion on Medical Diagnostics

Volumn 5, Issue 5, 2011, Pages 369-374

  Woodcock, Janet ^a   Buckman, Shaavhree ^a   Goodsaid, Federico ^a   Walton, Marc K ^a   Zineh, Issam ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biomarker; FDA; Qualification; Qualification process

Indexed keywords

BIOLOGICAL MARKER;

ADVISORY COMMITTEE; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; PROCESS DEVELOPMENT; QUALITATIVE ANALYSIS;

EID: 80052059669     PISSN: 17530059     EISSN: 17530067     Source Type: Journal    
DOI: 10.1517/17530059.2011.588947     Document Type: Editorial

References (11)

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