Testing hypotheses about the bioequivalence of drugs

Recieved: 04/20/2023

Accepted: 05/15/2023

Published: 11/28/2023

Keywords: statistical criterion, hypothesis, bioequivalence, significance level

To cite this article

Dranitsyna M.A., Zakharova T.V., Panov P.V. Testing hypotheses about the bioequivalence of drugs. // Moscow University Journal. Series 15. Computational Mathematics and Cybernetics. 2023. N 4, p.33-40 https://doi.org/10.55959/MSU/0137–0782–15–2023–47–4–33–40.

This work is licensed under a Сreative Commons Atribiution - NonCommercial 4.0 International (CC BY-NC 4.0)

Dranitsyna M.A. (Scientific Consulting Center LLC)
()
Zakharova T.V. (Lomonosov Moscow State University (MSU))
Panov P.V. (Lomonosov Moscow State University (MSU))

Abstract

The article deals with the task of testing drugs for bioequivalence. Bioequivalence studies underlie the reproduction of drugs that have confirmed their efficacy and safety. The main method for testing the bioequivalence hypothesis is the procedure of two one-way Schuirmann tests. Due to inaccurate data, as well as omitted data at the drug trial stage, the Schuirmann criterion allows for errors that exceed a given probability of error of the first kind. Such situations are dangerous for patients who may receive a drug that is not equivalent to the original drug. The authors presented a new criterion that is more sensitive to differences in characteristics affecting the bioavailability of drugs, which reduces patient risk. Note that the new criterion generalizes the classical Schuirmann criterion, preserving its useful properties.