Integration of pharmacogenetics and pharmacogenomics in drug development: Implications for regulatory and medical decision making in pediatric diseases

Journal of Clinical Pharmacology

Volumn 52, Issue 5, 2012, Pages 704-716

  Piana, Chiara ^a   Surh, Linda ^b   Furst Recktenwald, Sabine ^c   Iolascon, Achille ^d   Jacqz Aigrain, Evelyne M ^e   Jonker, Ineke ^f   Russo, Roberta ^g   Van Schaik, Ron H N ^h   Wessels, Judith ⁱ   Della Pasqua, Oscar E ^a,b  

^a LEIDEN UNIVERSITY   (Netherlands)

^b GLAXOSMITHKLINE   (United Kingdom)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^e HÔPITAL ROBERT DEBRÉ   (France)

^f Xendo Pharma Services BV Division Regulatory Affairs   (Netherlands)

^g CEINGE BIOTECNOLOGIE AVANZATE   (Italy)

^h ERASMUS MEDICAL CENTER   (Netherlands)

ⁱ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

clinical pharmacology; medical practice; pediatric drug development; Pharmacogenetics; regulatory scientific affairs

Indexed keywords

ACENOCOUMAROL; ANTIDEPRESSANT AGENT; ANTIRETROVIRUS AGENT; ATOMOXETINE; BIOLOGICAL MARKER; CARBAMAZEPINE; CYCLOSPORIN; DEFERIPRONE; METHOTREXATE; WARFARIN;

ANTICOAGULANT THERAPY; ASTHMA; ATTENTION DEFICIT DISORDER; CHILD DEVELOPMENT; CHILD GROWTH; CHILDHOOD DISEASE; CHILDHOOD LEUKEMIA; CLINICAL ASSESSMENT; CLINICAL PRACTICE; DATA ANALYSIS; DRUG METABOLISM; EPILEPSY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; INFECTION; MEDICAL DECISION MAKING; MEDICAL RECORD; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PHARMACOGENETICS; PHARMACOGENOMICS; REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS; TRANSPLANTATION; TREATMENT RESPONSE; VALIDATION PROCESS;

ADULT; AGE FACTORS; CHILD; DRUG APPROVAL; DRUG DISCOVERY; DRUG DOSAGE CALCULATIONS; DRUG LABELING; GENETIC MARKERS; HUMANS; INDIVIDUALIZED MEDICINE; PATIENT SAFETY; PATIENT SELECTION; PHARMACOGENETICS; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; RISK FACTORS;

EID: 82755188037     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011401619     Document Type: Review

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