Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US
Author:
Affiliation:
1. Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland
Publisher
American Medical Association (AMA)
Subject
General Medicine
Link
https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2769690/fisher_2020_oi_200525_1602624530.21084.pdf
Reference26 articles.
1. Dissolution testing for generic drugs: an FDA perspective.;Anand;AAPS J,2011
2. Dissolution failure of solid oral drug products in field alert reports.;Sun;J Pharm Sci,2017
3. Lack of medication dose uniformity in commonly split tablets.;Teng;J Am Pharm Assoc (Wash),2002
4. The future of pharmaceutical quality and the path to get there.;Yu;Int J Pharm,2017
5. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.;Davit;Ann Pharmacother,2009
Cited by 3 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
1. The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method;The AAPS Journal;2023-04-26
2. Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions;The AAPS Journal;2023-01-26
3. Dosage unit uniformity and dissolution testing of extended-release pharmaceutical products marketed in the U.S.;International Journal of Pharmaceutics;2022-09
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