Molecular biomarkers: A US FDA effort

Biomarkers in Medicine

Volumn 4, Issue 2, 2010, Pages 215-225

  Hong, Huixiao ^a   Goodsaid, Federico ^b   Shi, Leming ^a   Tong, Weida ^a  

^a NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

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

Author keywords

Drug; Labeling; Molecular biomarker; Pharmacogenomics; Qualification; Validation

Indexed keywords

CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DNA MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GLUCURONOSYLTRANSFERASE 1A1; HLA ANTIGEN; MENADIONE EPOXIDE; MOLECULAR MARKER; PROTEIN; RNA;

ALLELE; COPY NUMBER VARIATION; DATA MINING; DNA MICROARRAY; DNA SEQUENCE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; GENETIC MARKER; GENETIC VARIABILITY; HUMAN; METABOLITE; PHARMACOGENOMICS; PROTEIN EXPRESSION; RELIABILITY; REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM; STATISTICAL ANALYSIS;

ANIMALS; BIOLOGICAL MARKERS; BIOMARKERS, PHARMACOLOGICAL; DRUG APPROVAL; DRUG LABELING; GENETIC MARKERS; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77951483197     PISSN: 17520363     EISSN: None     Source Type: Journal    
DOI: 10.2217/bmm.09.81     Document Type: Review

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