(661c) A QbD Approach to Experimental Designs with Kinetic Parameters
AIChE Annual Meeting
2016
2016 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Quality By Design in Drug Substance Process Development
Thursday, November 17, 2016 - 9:12am to 9:33am
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.