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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Detalles Bibliográficos
Autores principales: Xu, Zhengguo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde, Merino, Virginia, García-Arieta, Alfredo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760601/
https://www.ncbi.nlm.nih.gov/pubmed/33260792
http://dx.doi.org/10.3390/pharmaceutics12121159

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760601/
https://www.ncbi.nlm.nih.gov/pubmed/33260792
http://dx.doi.org/10.3390/pharmaceutics12121159

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