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...
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) |
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Format: | Article |
Language: | English |
Published: |
Springer International Publishing,
2021-09-20T17:41:42Z.
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Subjects: | |
Online Access: | Get fulltext |
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