In-Vitro Methods to Assess Structural Similarity of Topical Products

In order to determine if diffusion measurements using a Franz cell can be used to provide a measure of bioequivalence for topical dosage forms, the CPST will conduct studies to find the optimal membrane for detecting formulation differences (Q3) in products that are otherwise equivalent to each other (QI and Q2), and to detect differences in thermodynamic activity of the drug substance in products that are QI and Q2 equivalent.