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.
Microgen - stock.adobe.com
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.
Click here for a PDF of this article.Click here for Table IV.Peer-reviewed research
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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
