Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms

Inter- and intra-batch variability of the quality attributes contribute to the uncertainty for demonstrating equivalent microstructure of post-approval changes and generic/hybrids of semisolid topical products. Selecting a representative sample size to describe accurately the in vitro properties of...

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Bibliographic Details
Main Authors: Zhengguo Xu (Author), Víctor Mangas-Sanjuán (Author), Matilde Merino-Sanjuán (Author), Virginia Merino (Author), Alfredo García-Arieta (Author)
Format: Book
Published: MDPI AG, 2020-11-01T00:00:00Z.
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3rd Floor Main Library

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