Product Development, Manufacturing, and Packaging of Solid Dosage Forms Under QbD and PAT Paradigm: DOE Case Studies for Industrial Applications

Author:

Singh Brahma N.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference101 articles.

1. Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25(4):781–91.

2. Debevec V, Srčič S, Horvat M. Scientific, statistical, practical, and regulatory considerations in design space development. Drug Dev Ind Pharm. 2018;44(3):349–64.

3. Q8(R2) ICH harmonized tripartite guideline for pharmaceutical development, current step 4 version dated August 2009 (Accessed Jan 31st, 2019).

4. FDA Guidance for Industry. Q8 pharmaceutical development. May 2006.

5. FDA Guidance for Industry. PAT—a framework for innovative pharmaceutical development, manufacturing, and quality assurance. September 2004 (Accessed June 16, 2019).

Cited by 10 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