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Verification and Validation of Computational Models Used in Biopharmaceutical Manufacturing: Potential Application of the ASME Verification and Validation 40 Standard and FDA Proposed AI/ML Model Life Cycle Management Framework.
J Pharm Sci. 2021 Apr;110(4):1540-1544. doi: 10.1016/j.xphs.2021.01.016. Epub 2021 Jan 23.
J Pharm Sci. 2021.
PMID: 33493480
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