(661a) A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing
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 - 8:30am to 8:51am
The Vertex approach to critical process parameter identification via an effect threshold concept will be discussed and accompanied by examples applying the method to drug substance development and manufacture.