Impact of Critical Material Attributes (CMAs)-Particle Shape on Miniature Pharmaceutical Unit Operations

Abstract The U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a C...

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Bibliographic Details
Main Authors: Azad, Mohammad A (Author), Capellades, Gerard (Author), Wang, Allison B (Author), Klee, David M (Author), Hammersmith, Gregory (Author), Rapp, Kersten (Author), Brancazio, David (Author), Myerson, Allan S (Author)
Format: Article
Language:English
Published: Springer International Publishing, 2021-09-20T17:41:53Z.
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