472550 A QbD Approach to Experimental Designs with Kinetic Parameters

Thursday, November 17, 2016: 9:12 AM
Continental 4 (Hilton San Francisco Union Square)
Michael Ryan and David Willcox, Vertex Pharmaceuticals Inc., Boston, MA

Kinetic parameters are commonly ignored when applying traditional DoE approaches to chemiscal reactions, resulting in a failure to accurately capture and describe the time-dependent nature of the system. An alternative method utilizes such parameters as responses in the traditional DoE, allowing the impact of process parameters on the chemical kinetics to be evaluated and communicated within a standardized QbD framework.

Extended Abstract: File Not Uploaded