Performance-Based Quality Specifications: The Relationship Between Process Critical Control Parameters, Critical Quality Attributes, and Clinical Performance-Reference-Cited by-同舟云学术

Performance-Based Quality Specifications: The Relationship Between Process Critical Control Parameters, Critical Quality Attributes, and Clinical Performance

Published:2011-04 Issue:4 Volume:100 Page:1566-1575
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Short Steven M.,Cogdill Robert P.,Drennen James K.,Anderson Carl A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference19 articles.

1. Risk-based quality by design (QbD): A Taguchi perspective on the assessment of product quality, and the quantitative linkage of drug product parameters and clinical performance;Cogdill;J Pharm Innov,2008

2. A new definition of pharmaceutical quality: Assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance;Short;J Pharm Sci,2010

3. Investigation of the statistical power of the content uniformity tests using simulation studies;Lunney;J Pharm Innov,2009

4. Three-stage sequential dissolution testing rules;Tsong;J Biopharm Stat,2004

5. Pharmaceutical CGMPs for the 21st century–A risk-based approach: Final report;Department of Health and Human Services,2004

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