The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment.
Califf
Robert M
RM
Duke Translational Medicine Institute, Durham, NC 27715, USA. robert.califf@duke.edu
Kramer
Judith M
JM
D009202:Cardiomyopathies / Q000139:chemically induced*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D017277:Drug Approval / Q000331:legislation & jurisprudence; D005786:Gene Expression Regulation / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D009316:National Institutes of Health (U.S.) / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011640:Public Policy; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone