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Tags: critical material attributes (CMAs)

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Peer-reviewed journal (1-1 of 1)

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

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    09 Jun 2023 | Contributor(s):: Azad, Mohammad A., Capellades, Gerard Wang, Allison B. Klee, David M., Hammersmith, Gregory, Rapp, Kersten, Brancazio, David, Myerson, Allan S.

    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 CMA)...