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
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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
โ 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
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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