Quality by Design: an Overview of the Basic Concepts


The premise ofQuality byDesign (QbD) is that the quality of the pharmaceutical product should be based upon the understanding of the biology or the mechanism of action (MOA) and the safety of the molecule [1]. The manufacturing process should then be developed to meet the desired quality attributes of the molecule, hence the concept of “design” of the… (More)


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@inproceedings{Mhatre2009QualityBD, title={Quality by Design: an Overview of the Basic Concepts}, author={Rohin Mhatre and Anurag S. Rathore}, year={2009} }