Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence
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 to compare the microstructure-defining physical parameters of different batches of a...
Saved in:
Main Authors: | Víctor Mangas-Sanjuán (Author), María Pleguezuelos-Villa (Author), Matilde Merino-Sanjuán (Author), Mª Jesús Hernández (Author), Amparo Nácher (Author), Alfredo García-Arieta (Author), Daniel Peris (Author), Irene Hidalgo (Author), Lluís Soler (Author), Marta Sallan (Author), Virginia Merino (Author) |
---|---|
Format: | Book |
Published: |
MDPI AG,
2019-10-01T00:00:00Z.
|
Subjects: | |
Online Access: | Connect to this object online. |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Similar Items
-
Erratum: Mangas-Sanjuán, V.; et al. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence. <i>Pharmaceutics</i> 2019, <i>11</i>, 503
by: Víctor Mangas-Sanjuán, et al.
Published: (2020) -
Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms
by: Zhengguo Xu, et al.
Published: (2020) -
Impact of Time on Parameters for Assessing the Microstructure Equivalence of Topical Products: Diclofenac 1% Emulsion as a Case Study
by: Andreu Mañez-Asensi, et al.
Published: (2024) -
Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union
by: Alfredo García-Arieta, et al.
Published: (2023) -
Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making
by: Javier Reig-López, et al.
Published: (2021)