Lei Lei

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Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Articles

Skin Prick Allergy Testing |Image Credit: © Microgen - © Microgen - stock.adobe.com

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Lei Lei

July 3rd 2023

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.

Robert Kneschke/Stock.adobe.com - an evaluation of the in-vitro permeation test study data processing procedures and FDA statistical mathematics for determing the bioequivalence of the generic topical drug product, acyclovir cream, against its reference product.

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

Lei Lei;Ashvin Patel

June 3rd 2022

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.

Determining the Probability of Passing USP Content Uniformity and Dissolution - Immediate and Extended - Tests with CuDAL-Excel

Lei Lei;Pramote Cholayudth

May 2nd 2020

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.