Learning from product labels and label changes: How to build pharmacogenomics into drug-development programs

Pharmacogenomics

Volumn 11, Issue 12, 2010, Pages 1637-1647

  Surh, Linda C ^a   Pacanowski, Michael A ^b   Haga, Susanne B ^c   Hobbs, Stuart ^d   Lesko, Lawrence J ^b   Gottlieb, Scott ^e   Papaluca Amati, Marisa ^f   Patterson, Scott D ^g   Hughes, Arlene R ^d   Kim, Myong Jin ^b   Close, Sandra L ^h   Mosteller, Michael ^d   Zineh, Issam ^b   Dechairo, Bryan ⁱ   Cohen, Nadine A ^j  

^a GLAXOSMITHKLINE   (United Kingdom)

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

^c DUKE UNIVERSITY   (United States)

^d GLAXOSMITHKLINE   (United States)

^e AMERICAN ENTERPRISE INSTITUTE   (United States)

^f EUROPEAN MEDICINES AGENCY   (United Kingdom)

^g AMGEN INC   (United States)

^h ELI LILLY AND COMPANY   (United States)

ⁱ Personalized Medicine Medco Health   (United States)

^j JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

more..

Author keywords

biomarkers; genetic tests; pharmacogenetics; pharmacogenomics; product label; summary of product characteristics; US prescribing information

Indexed keywords

ABACAVIR; CARBAMAZEPINE; CETUXIMAB; CLOPIDOGREL; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; HLA B ANTIGEN; IMATINIB; IRINOTECAN; K RAS PROTEIN; MARAVIROC; MERCAPTOPURINE; PANITUMUMAB; WARFARIN;

ARTICLE; BLEEDING; CARDIOVASCULAR DISEASE; COLORECTAL CARCINOMA; DRUG APPROVAL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; EPILEPSY; GENETIC SCREENING; HEREDITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICAL DECISION MAKING; MEDICAL PRACTICE; MEDICAL SOCIETY; PHARMACOGENOMICS; PRACTICE GUIDELINE; PRESCRIPTION; PROTEIN EXPRESSION; RISK BENEFIT ANALYSIS; SKIN DISEASE; THROMBOSIS; WORKSHOP;

BIOMARKERS, PHARMACOLOGICAL; DRUG DESIGN; DRUG INDUSTRY; DRUG LABELING; GOVERNMENT PROGRAMS; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78650323416     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.10.138     Document Type: Article

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