A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability
Open accessAbstract
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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The simplest and most widely used approach to test equivalence is the two one-sided test (TOST) procedure.
“The simplest and most widely used approach to test equivalence is the two one-sided test (TOST) procedure 2 .”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [2]
The section “THE TWO ONE-SIDED TESTS PROCEDURE” describes TOST as an equivalence test using two ordinary one-sided t tests, supporting its identification as an approach to testing equivalence. The paper does not establish that TOST is the simplest or most widely used approach; its opening section instead says the power approach continued to be used in bioequivalence studies. The supplied passages have no page numbers. (LLM, conf=0.84)
Experimental — accuracy not yet measuredUnder equivalence testing (TOST), the null hypothesis is that the disparity equals or exceeds the regulatory tolerance, and a model passes only when the data provide affirmative evidence that the disparity is within tolerance.
“We adopt equivalence testing (TOST) (Schuirmann, 1987), under which the null hypothesis is that the disparity equals or exceeds the regulatory tolerance. A model passes only when the data provide affirmative evidence that the disparity is within tolerance.”
From Fairness Testing for Algorithmic Pricing (2026) · cites this paper as Schuirmann, 1987
Using TOST, equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies is contained within the interval (-δ, δ).
“Using TOST, equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (newcurrent) is contained within the interval (-δ, δ) (Fig. 1).”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [2]
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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
- Published
- 1987-12
- Volume
- 15
- Issue
- 6
- Pages
- 657-680
- ISSN
- 0090-466X (ISSN-L)
- 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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