Search results for "generic semisolid formulation"

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

2019

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 reference ointment containing calcipotriol and betamethasone (Daivobet 50 &micro

microstructureequivalencelcsh:RS1-441Pharmaceutical Sciencegeneric semisolid formulation02 engineering and technology030226 pharmacology & pharmacyDosage formArticlelcsh:Pharmacy and materia medica03 medical and health sciences0302 clinical medicinetopical drugStatisticsinter-batch variabilityEquivalence (measure theory)Parametric statisticsMathematics021001 nanoscience & nanotechnologyMicrostructureConfidence intervalReference productSample size determinationDrug releaserheology0210 nano-technologyPharmaceutics
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