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