Misunderstanding Design Space: a Robust Drug Product Control Strategy Is the Key to Quality Assurance-Reference-Cited by-同舟云学术

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Misunderstanding Design Space: a Robust Drug Product Control Strategy Is the Key to Quality Assurance

Published:2018-08-11 Issue:3 Volume:13 Page:283-285
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Watson Timothy J. N.^ORCID,Nosal Roger,Lepore John,Montgomery Frank

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Link

http://link.springer.com/article/10.1007/s12247-018-9338-9/fulltext.html

Cited by 7 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. Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey;Pharmaceutical Research;2024-09-04

2. Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling;Pharmaceutics;2024-02-26

3. TECHNOLOGICAL CHALLENGES IN STERILE PRODUCTOS MANUFACTURING: IS PHARMACEUTICAL INDUSTRY TRAINED?;DYNA;2022-03-01

4. Process optimization for the synthesis of functionalized Au@AgNPs for specific detection of Hg²⁺ based on quality by design (QbD);RSC Advances;2022

5. Impact of Process Parameters and Formulation Properties on Dissolution Performance of an Extended Release Tablet: a Multivariate Analysis;Journal of Pharmaceutical Innovation;2021-07-14

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