US FDA perspective on challenges in co-developing in vitro companion diagnostics and targeted cancer therapeutics

Bioanalysis

Volumn 3, Issue 4, 2011, Pages 383-389

  Philip, Reena ^a   Carrington, Lea ^a   Chan, Maria ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

BCR ABL PROTEIN; BIOLOGICAL MARKER; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; GEFITINIB; GLUCURONOSYLTRANSFERASE 1A1; IMATINIB; IRINOTECAN; K RAS PROTEIN; PANITUMUMAB; STEM CELL FACTOR RECEPTOR; TRASTUZUMAB;

ARTICLE; CANCER DIAGNOSIS; CANCER SCREENING; CANCER THERAPY; CLINICAL EFFECTIVENESS; DECISION MAKING; DIAGNOSTIC IMAGING; DIAGNOSTIC TEST; DRUG INDUSTRY; DRUG RESPONSE; FLUORESCENCE IN SITU HYBRIDIZATION; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN GENOME PROJECT; IMMUNOHISTOCHEMISTRY; IN VITRO STUDY; MEDICAL INSTRUMENTATION; PERSONALIZED MEDICINE; QUALITY CONTROL; RISK FACTOR; TUMOR BIOPSY;

DRUG DISCOVERY; GOVERNMENT REGULATION; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR TARGETED THERAPY; NEOPLASMS; REAGENT KITS, DIAGNOSTIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79952015320     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.1     Document Type: Article

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