Can modeling of health outcomes facilitate regulatory decision making? The benefit-risk tradeoff for rosiglitazone in 1999 vs. 2007

Clinical Pharmacology and Therapeutics

Volumn 89, Issue 3, 2011, Pages 429-436

  Cross, J T ^a,b   Veenstra, D L ^a   Gardner, J S ^a   Garrison Jr , L P ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLIBENCLAMIDE; HEMOGLOBIN A1C; METFORMIN; ROSIGLITAZONE;

ADULT; ADVISORY COMMITTEE; ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DRUG APPROVAL; DRUG MARKETING; DRUG WITHDRAWAL; FEMALE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE FACILITY; HUMAN; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL MODEL; MEDICAL DECISION MAKING; MONOTHERAPY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR;

DECISION MAKING, ORGANIZATIONAL; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; FEMALE; GLYBURIDE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; MODELS, THEORETICAL; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY-ADJUSTED LIFE YEARS; THIAZOLIDINEDIONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79951812578     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.350     Document Type: Article

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