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Autor:
Rajiv Mahajan, Mark Waskiewicz, Michel Chartrain, Yang Wang, Beth Junker, Mike Kosinski, Katie Ezis, Dephillips Peter A, Randy Henrickson, Brian K. Meyer, David Geer
Publikováno v:
PDA journal of pharmaceutical science and technology. 65(3)
An initial quality-by-design (QbD) framework was assembled for biopharmaceutical product, process, and analytical development using the design-for-six-sigma (DFSS) methodology. This technique was both streamlined and efficient, which permitted develo