The impact of FDA guidance on pharmacogenomic data submissions on drug development

IDrugs

Volumn 8, Issue 8, 2005, Pages 648-650

  Little, Stephen ^a  

^a DxS Ltd   (United Kingdom)

Author keywords

Biomarker; Drug development; Genetic analysis; Genotyping; Pharmacogenetic assays; Pharmacogenomic analysis; Regulatory framework; Regulatory submission; Specific genetic tests

Indexed keywords

ANTINEOPLASTIC AGENT; CYTOCHROME P450 2C19; CYTOCHROME P450 2C8; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; DRUG; EPIDERMAL GROWTH FACTOR RECEPTOR; RAF PROTEIN; RAS PROTEIN;

ARTICLE; DNA POLYMORPHISM; DRUG INDUSTRY; DRUG METABOLISM; DRUG SYNTHESIS; FOOD AND DRUG ADMINISTRATION; GENOME; GENOTYPE PHENOTYPE CORRELATION; HUMAN; IN VITRO STUDY; PHARMACOGENOMICS; PRACTICE GUIDELINE;

DATABASES, GENETIC; GENE TARGETING; GUIDELINES; PHARMACOGENETICS; PHARMACOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 23244435999     PISSN: 13697056     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

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