Prasanth Sambaraju

HTTPS://STOCK.ADOBE.COM Equivalence tests often are used for demonstrating bioequivalence between two biopharmaceutical formulations, with the two one-sided test (TOST) being a common, regulator-accepted statistical method for testing equivalence in a two-group parallel design (1). TOSTs can be used to assess comparability for method transfer between laboratories. Chen et al. have applied it to evaluate the comparability of two groups of cleanability data from a bench-scale study (2).

By Prasanth Sambaraju Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.