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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| Główni autorzy: | , , , , |
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| Format: | Artigo |
| Język: | Inglês |
| Wydane: |
MDPI AG
2020-11-01
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| Seria: | Pharmaceutics |
| Hasła przedmiotowe: | |
| Dostęp online: | https://www.mdpi.com/1999-4923/12/12/1159 |
| Etykiety: |
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