In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance
FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.
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This article describes the data processing procedures and FDA statistical mathematics of an in-vitro permeation test (IVPT) study for evaluating a generic topical drug product against its reference product. IVPT-Stat v2.0, a tool composed of two Microsoft (MS) Excel files, is provided in the present paper to perform FDA statistic bioequivalence analysis with IVPT data (i.e., maximum flux [Jmax] and total cumulative amount permeated [denoted as AMT]) of the test and reference topical drug products. The algorithms and use of IVPT-Stat v2.0 are also elucidated with examples. As a MS Excel-based tool, IVPT-Stat v2.0 is user friendly and can be easily run by most industry practitioners and should make IVPT data analysis easy.
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Submitted: Feb. 17, 2023
Accepted: March 29, 2023
About the author
Lei Lei, PhD, ryan.lei@cutiatx.com, is the senior vice-president R&D of Cutia Therapeutics, Shanghai, China.
Article details
Pharmaceutical Technology
Vol, 47, No. 7
July 2023
Pages: 30–35
Citation
When referring to this article, please cite it as Lei, L. In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance. Pharmaceutical Technology 2023, 47 (7), 30–35.
