Impact of Time on Parameters for Assessing the Microstructure Equivalence of Topical Products: Diclofenac 1% Emulsion as a Case Study

• Main Authors: Andreu Mañez-Asensi (Author), Mª Jesús Hernández (Author), Víctor Mangas-Sanjuán (Author), Ana Salvador (Author), Matilde Merino-Sanjuán (Author), Virginia Merino (Author)
• Format: Book
• Published: MDPI AG, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The demonstration of bioequivalence proposed in the European Medicines Agency's (EMA's) draft guideline for topical products with the same qualitative and quantitative composition requires the confirmation of the internal structure equivalence. The impact of the shelf-life on the parameter...