Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan

Journal of Clinical Pharmacy and Therapeutics

Volumn 39, Issue 2, 2014, Pages 210-214

  Shimazawa, R ^a   Ikeda, M ^b  

^a KYUSHU UNIVERSITY   (Japan)

^b KAGAWA UNIVERSITY HOSPITAL   (Japan)

Author keywords

biomarkers; drug approval; in vitro diagnostic devices; personalized medicine; pharmacogenomics; USFDA

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; ANTITHROMBIN III; APOLIPOPROTEIN E2; B RAF KINASE; BIOLOGICAL MARKER; BLOOD CLOTTING FACTOR 5 LEIDEN; CD20 ANTIGEN; CD30 ANTIGEN; CHEMOKINE RECEPTOR CCR5; CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; DIHYDROPYRIMIDINE DEHYDROGENASE; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; GLUCOSE 6 PHOSPHATE DEHYDROGENASE; HLA B ANTIGEN; HYPOXANTHINE PHOSPHORIBOSYLTRANSFERASE; INTERLEUKIN 2 RECEPTOR ALPHA; INTERLEUKIN 28B; K RAS PROTEIN; LOW DENSITY LIPOPROTEIN RECEPTOR; NORADRENALIN TRANSPORTER; PHARMACOGENOMIC BIOMARKER; PLATELET DERIVED GROWTH FACTOR ALPHA RECEPTOR; PROGESTERONE RECEPTOR; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ARTICLE; CHROMOSOME 5Q; COMPANION DIAGNOSTIC DEVICE; CROSS-SECTIONAL STUDY; DEVICE APPROVAL; DIAGNOSTIC EQUIPMENT; DRUG APPROVAL; ENDOCRINOLOGY; FOOD AND DRUG ADMINISTRATION; GASTROENTEROLOGY; HEMATOLOGY; HUMAN; IN VITRO STUDY; JAPAN; NATIONAL HEALTH INSURANCE; NEUROLOGY; ONCOLOGY; PERSONALIZED MEDICINE; PHARMACOGENOMICS; TRANSPLANTATION; UNITED STATES;

BIOMARKERS; DRUG APPROVAL; IN VITRO DIAGNOSTIC DEVICES; PERSONALIZED MEDICINE; PHARMACOGENOMICS; USFDA;

BIOLOGICAL MARKERS; CROSS-SECTIONAL STUDIES; DIAGNOSTIC TEST APPROVAL; DIAGNOSTIC TESTS, ROUTINE; HEALTH SERVICES ACCESSIBILITY; HUMANS; INDIVIDUALIZED MEDICINE; JAPAN; PHARMACOGENETICS; UNITED STATES;

EID: 84895522026     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/jcpt.12129     Document Type: Article

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