PILOT EQUIVALENCE STUDY COMPARING DIFFERENT BATCHES OF TOPICAL 0.025% CAPSAICIN EMULSION: PRODUCT MICROSTRUCTURE, RELEASE, AND PERMEATION EVALUATION

Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation

The European Medical Agency (EMA) has issued a draft guideline on the quality and equivalence of topical products.The equivalence for complex semisolid formulations involves several steps: the same quantitative content, the same microstructure, the same release, and Doll permeation profile.In this paper, several batches of a low strength topical pr

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