Generic drugs--safe, effective, and affordable.
This article discusses the history and evolution of the process for generic drug evaluation and approval in the United States, with emphasis on locally acting dermatologic products. The requirements for in vivo bioequivalence (BE) testing and the statistical criteria for BE are discussed, and an example of a topical antifungal dermatologic product is used to demonstrate the BE determination for locally acting drugs. Other factors in the dispensing of prescription medications that are not within the Food and Drug Administration regulatory authority are also mentioned.
Peters
John R
JR
Office of Generic Drugs, U.S. Food and Drug Administration, Rockville, Maryland 20855, USA.
Hixon
Dena R
DR
Conner
Dale P
DP
Davit
Barbara M
BM
Catterson
Debra M
DM
Parise
Cecelia M
CM
D003879:Dermatologic Agents / Q000191:economics / Q000627:therapeutic use*; D003880:Dermatology; D017277:Drug Approval; D016527:Drug Costs; D016568:Drugs, Generic / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D012871:Skin Diseases / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D003879:Dermatologic Agents; D016568:Drugs, Generic