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Browsing by Author "García-Arieta, Alfredo"

Now showing items 1-4 of 4

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

Mangas-Sanjuan, Victor; Pleguezuelos-Villa, María; Merino-Sanjuán, Matilde; Hernández, Mª Jesús; Nácher, Amparo; García-Arieta, Alfredo; Peris, Daniel; Hidalgo, Irene; Soler, Lluís; Sallan, Marta; Merino, Virginia (MDPI AG, 2019-10)

[EN] Demonstration of similar microstructure is essential for demonstrating the equivalence of generic topical products since the microstructure of semisolids may affect the drug release. The objective of this study was ...
Bioequivalence risk assessment of oral formulations containing racemic ibuprofen through a chiral physiologically based pharmacokinetic model of ibuprofen enantiomers

Reig-López, Javier; M. Cuquerella-Gilabert; Bandín-Vilar, Enrique; Merino-Sanjuán, Matilde; Mangas-Sanjuán, Victor; García-Arieta, Alfredo (Elsevier, 2024-06)

[EN] The characterization of the time course of ibuprofen enantiomers can be useful in the selection of the most sensitive analyte in bioequivalence studies. Physiologically based pharmacokinetic (PBPK) modelling and ...
Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool

Figueroa-Campos, Andrés; Sánchez-Dengra, Bárbara; Merino, Virginia; Dahan, Arik; Gonzalez-Alvarez, Isabel; García-Arieta, Alfredo; Gonzalez-Alvarez, Marta; Bermejo, Marival (MDPI AG, 2020-07)

[EN] The main objective of this investigation was to develop an in vitro-in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by designing an in vitro dissolution test to be used as development ...
Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms

Xu, Zhengguo; Mangas-Sanjuan, Victor; Merino-Sanjuán, Matilde; Merino, Virginia; García-Arieta, Alfredo (MDPI AG, 2020-12)

[EN] 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 ...

Now showing items 1-4 of 4

Browsing by Author "García-Arieta, Alfredo"

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Browsing by Author "García-Arieta, Alfredo"