Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA.
Clin Pharmacol Ther. 2013 Oct;94(4):438-40. doi: 10.1038/clpt.2013.104.
Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product. Through new bioequivalence study designs for narrow therapeutic index (NTI) drugs and postapproval studies of generic substitution, the US Food and Drug Administration's (FDA's) ongoing generic drug regulatory science activities are designed to ensure successful generic substitution for all drug products.
患者应该相信，他们在美国开的仿制药可以有效地替代品牌产品或另一种仿制药。通过为治疗指数较窄（NTI）药物制定新的生物等效性研究设计和仿制药替代的上市后研究，美国食品和药物管理局（FDA）正在进行的仿制药监管科学活动旨在确保所有药物产品都能成功进行仿制药替代。
