FDA mulls changes to bioequivalence standards.
作者信息
Traynor Kate
出版信息
Am J Health Syst Pharm. 2010 Jun 1;67(11):864. doi: 10.2146/news100040.
PMID:20484205
Abstract
摘要
相似文献
1
FDA mulls changes to bioequivalence standards.美国食品药品监督管理局考虑修改生物等效性标准。
Am J Health Syst Pharm. 2010 Jun 1;67(11):864. doi: 10.2146/news100040.
2
FDA moves closer to new requirements for NTI drugs.
Am J Health Syst Pharm. 2011 Sep 1;68(17):1568-9, 1570. doi: 10.2146/news110059.
3
Modeling and simulation of biopharmaceutical performance.生物制药性能的建模与仿真。
Clin Pharmacol Ther. 2014 May;95(5):480-2. doi: 10.1038/clpt.2014.40.
4
Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.比较仿制药和创新药：对美国食品药品监督管理局12年生物等效性数据的综述
Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23.
5
Viewpoint: observations on scaled average bioequivalence.观点：关于标度平均生物等效性的观察
Pharm Stat. 2012 Jan-Feb;11(1):1-7. doi: 10.1002/pst.498. Epub 2011 Dec 8.
6
Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review.比较仿制药与品牌药的生物等效性试验报告质量的方法学系统评价。
PLoS One. 2011;6(8):e23611. doi: 10.1371/journal.pone.0023611. Epub 2011 Aug 17.
7
The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.美国食品药品监督管理局的仿制药审批流程：与品牌药的异同
Am J Gastroenterol. 2011 Jun;106(6):1018-21. doi: 10.1038/ajg.2011.29.
8
United States Food and Drug Administration requirements for approval of generic drug products.美国食品药品监督管理局对仿制药产品批准的要求。
J Clin Psychiatry. 2001;62 Suppl 5:4-9; discussion 23-4.
9
Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.支持眼科药品生物等效性的临床、药代动力学和体外研究。
AAPS J. 2016 Jul;18(4):1032-8. doi: 10.1208/s12248-016-9932-z. Epub 2016 May 16.
10
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.美国食品和药物管理局实施参照标度平均生物等效性方法评估高度变异仿制药产品。
AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13.
Zotero 插件