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This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
This article describes the data processing procedures used by the authors from in-vitro permeation test (IVPT) studies. The article also discusses FDA statistical mathematics of evaluating a generic topical drug product, specifically acyclovir cream, against its reference product. The authors demonstrate the use of IVPT-Stat, a statistical tool based on Microsoft (MS) Excel, which has been developed to perform FDA statistic bioequivalence (BE) analysis on data that contains cutaneous pharmacokinetic parameters (maximum flux, Jmax, and total cumulative amount permeated, denoted as AMT) of the test (T) and reference (R) topical drugs. The authors use examples to illustrate the algorithms and functionalities of the IVPT-Stat tool.
Submitted: May 2, 2022
Accepted: May 9, 2022
Lei Lei*, PhD, firstname.lastname@example.org, is the vice-president R&D of Cutia Therapeutics, Shanghai, China, and Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.
*To whom all correspondence should be addressed.
Vol. 46, No. 6
When referring to this article, please cite it as L. Lei and A. Patel, “IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence,” Pharmaceutical Technology 46 (6) 36–42 (2022).