๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

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

โœ Scribed by Robert P. Cogdill; James K. Drennen


Book ID
107635816
Publisher
Springer US
Year
2008
Tongue
English
Weight
296 KB
Volume
3
Category
Article
ISSN
1872-5120

No coin nor oath required. For personal study only.


๐Ÿ“œ SIMILAR VOLUMES


Examining the impact of excipient materi
โœ JOSEPH Kushner IV; Beth A. Langdon; Jon I. Hiller; Glenn T. Carlson ๐Ÿ“‚ Article ๐Ÿ“… 2011 ๐Ÿ› John Wiley and Sons ๐ŸŒ English โš– 983 KB

A quality-by-design study examining the impact of variability in excipient material properties on the quality attributes of an immediate release tablet was performed. A literature review and risk analysis identified particle size of microcrystalline cellulose (MCC), spray-dried lactose (SDL), and ma

A new definition of pharmaceutical quali
โœ Steven M. Short; Robert P. Cogdill; Frank D'Amico; James K. Drennen III; Carl A. ๐Ÿ“‚ Article ๐Ÿ“… 2010 ๐Ÿ› John Wiley and Sons ๐ŸŒ English โš– 477 KB ๐Ÿ‘ 1 views

The absence of a unanimous, industry-specific definition of quality is, to a certain degree, impeding the progress of ongoing efforts to "modernize" the pharmaceutical industry. This work was predicated on requests by Dr. Woodcock (FDA) to re-define pharmaceutical quality in terms of risk by linking