Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology

Author:

Lechat PhilippeORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference25 articles.

1. EMA guideline on the investigation of bioequivalence. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf. Accessed 24 June 2022.

2. EMA: Questions and answers on bioequivalence studies. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers. Accessed 24 June 2022.

3. FDA guideline on bioequivalence. Guidance for industry bioavailability and bioequivalence studies submitted in NDAs or INDs—general considerations. https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-%E2%80%94-General-Considerations.pdf. Accessed 24 June 2022.

4. Davit BM, Nwakama PE, Conner GP, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the united states food and drug administration. Ann Pharmacother. 2009;43:1583–97.

5. Approved products with therapeutic equivalence evaluation. 29th ed. Washington DC: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of pharmaceutical sciences, Office of generic drugs, 2009. https://www.fda.gov/media/71474/download. Accessed 24 June 2022.

Cited by 6 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3