OR WAIT null SECS
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.
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.
Submitted: Feb. 17, 2023
Accepted: March 29, 2023
Lei Lei, PhD, firstname.lastname@example.org, is the senior vice-president R&D of Cutia Therapeutics, Shanghai, China.
Vol, 47, No. 7
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.