A curve similarity approach to parallelism testing in bioassay. Issue 4 (3rd July 2020)

• Record Type: Journal Article
• Authors: Faya, Paul; Rauk, Adam P.; Griffiths, Kristi L.; Parekh, Bhavin
• Is Part Of: Journal of biopharmaceutical statistics. Volume 30:Issue 4(2020)
• Page Start: 721
• Page End: 733
• Publication Date: 2020-07-03
• Subjects: Equivalence -- potency -- pharmaceutical -- reference standard -- dose-response -- 4PL; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2020.1730875
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: Potency determination via bioassay is a relative measure that requires an evaluation of parallelism between the dose–response relationships of a reference standard and a sample material. Typical approaches for assessing parallelism include difference ( p -value) and equivalence tests. These traditional methods rely on a statistical assessment of model parameters as opposed to direct evaluation of the similarity of the dose–response curves. We propose a simple curve similarity approach that tests the hypothesis that the sample material is a dilution or concentration of the reference standard. The test is achieved by quantifying and normalizing the total area between the two curves and provides a single composite measure of parallelism. Both a frequentist and a Bayesian approach to the test are provided. We show through a simulation study that the curve similarity approach overcomes the drawbacks of the traditional methods and is effective at detecting parallelism and non-parallelism for bioassays.