Cited by 2,696Statistical Methods in Clinical TrialsBiosimilars and Bioanalytical MethodsPharmaceutical studies and practices

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A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

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Schuirmann, Donald J.·1987·Journal of Pharmacokinetics and Biopharmaceutics

DOI 10.1007/bf01068419

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Abstract

The statistical test of hypothesis of no difference between the average bioavailabilities of two drug formulations, usually supplemented by an assessment of what the power of the statistical test would have been if the true averages had been inequivalent, continues to be used in the statistical analysis of bioavailability/bioequivalence studies. In the present article, this Power Approach (which in practice usually consists of testing the hypothesis of no difference at level 0.05 and requiring an estimated power of 0.80) is compared to another statistical approach, the Two One-Sided Tests Procedure, which leads to the same conclusion as the approach proposed by Westlake based on the usual (shortest) 1-2 alpha confidence interval for the true average difference. It is found that for the specific choice of alpha = 0.05 as the nominal level of the one-sided tests, the two one-sided tests procedure has uniformly superior properties to the power approach in most cases. The only cases where the power approach has superior properties when the true averages are equivalent correspond to cases where the chance of concluding equivalence with the power approach when the true averages are not equivalent exceeds 0.05. With appropriate choice of the nominal level of significance of the one-sided tests, the two one-sided tests procedure always has uniformly superior properties to the power approach. The two one-sided tests procedure is compared to the procedure proposed by Hauck and Anderson.

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A new procedure for testing equivalence in comparative bioavailability and other clinical trials
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Authors: Schuirmann, D. J.
Affiliations: United States Food and Drug Administration (US)
Corresponding author: Schuirmann, Donald J.
Venue: Journal of Pharmacokinetics and Biopharmaceutics
Publisher: Springer Science and Business Media LLC
Published: 1987-12
Volume: 15
Issue: 6
Pages: 657-680
ISSN: 0090-466X (ISSN-L)
DOI: 10.1007/bf01068419
OpenAlex: W2037698344
Cited by: 2,696
References: 8
Citations by year: 2026: 229 · 2025: 113 · 2024: 97 · 2023: 91 · 2022: 101 · 2021: 104 · 2020: 115 · 2019: 106 · 2018: 112 · 2017: 89 · 2016: 75 · 2015: 65 · 2014: 86 · 2013: 69 · 2012: 74
FWCI: 14.93
Type: journal article
Language: en
Open access: green
zenodo.org
Licence: public-domain
www.springer.com/tdm (tdm)
Locations: Journal of Pharmacokinetics and Biopharmaceutics (publishedVersion)
PubMed (publishedVersion)
Zenodo (CERN European Organization for Nuclear Research) (submittedVersion, public-domain)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: bioequivalence, statistical power, bioequivalence testing, confidence intervals, type I error, drug formulation
MeSH terms: Biological Availability, Models, Biological, Pharmacokinetics, Statistics as Topic

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A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

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