Model-Guided Design Space Development for a Drug Substance Manufacturing Process
An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design
Unit Operation: Reaction
Objective: QbD
Company: BMS
Source: Journal of Pharmaceutical Innovation
Authors: Alan D. Braem (BMS), Justin Burt (BMS), Boguslaw Mudryk (BMS), Antonio Ramirez (BMS), Lucius Rossano (BMS), Srinivas Tummala (BMS)
Publish Date: 26-Jul-2011
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