Modeling-Based Approach Towards Quality by Design for the Ibipinabant API Step
Author:
Affiliation:
1. Chemical Development, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, New Jersey 08903, United States
Publisher
American Chemical Society (ACS)
Subject
Organic Chemistry,Physical and Theoretical Chemistry
Link
https://pubs.acs.org/doi/pdf/10.1021/op2003024
Reference13 articles.
1. PQLI Key Topics - Criticality, Design Space, and Control Strategy
2. PQLI Design Space
3. The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis
4. ICH Q8 Pharmaceutical Development;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, August 2009.
Cited by 19 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. Design Space Identification of the Rotary Tablet Press;Systems and Control Transactions;2024-07-09
2. Use of Bayesian Modeling for Risk Assessment and Robustness Evaluation;Organic Process Research & Development;2024-01-29
3. Mathematical Modeling and Optimization to Inform Impurity Control in an Industrial Active Pharmaceutical Ingredient Manufacturing Process;Organic Process Research & Development;2022-09-21
4. Application of a System Model for Continuous Manufacturing of an Active Pharmaceutical Ingredient in an Industrial Environment;Journal of Pharmaceutical Innovation;2022-01-19
5. Microbial technologies for biotherapeutics production: Key tools for advanced biopharmaceutical process development and control;Drug Discovery Today: Technologies;2020-12
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