Fixed combination drugs for cardiovascular disease risk reduction: regulatory approach.
The use of combination drug therapy for cardiovascular (CV) disease risk reduction is the established approach to multiple risk factor reduction. The spectrum of rational combination products in CV disease prevention and treatment alone is extremely broad. Development of fixed-dose combination drug products requires information beyond that needed for approval of single active ingredient products. Establishing the rationale and target populations for novel combinations, as well as the contributions of the component drugs to the claimed effects, and characterizing the pharmacokinetics, the pharmacodynamics, and clinical safety and efficacy of the combination are all necessary to support approval.
Orloff
David G
DG
US Food and Drug Administration, Rockville, Maryland 20857-0001, USA. orloffd@cder.fda.gov
D002318:Cardiovascular Diseases / Q000188:drug therapy*; D004338:Drug Combinations; D006801:Humans; D010599:Pharmacokinetics; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
D004338:Drug Combinations