Bioequivalence Testing -- A Need to Rethink

Kirkwood, Thomas B. L.; Westlake, Wilfred J.

doi:10.2307/2530573

Cited by 172 publications

(43 citation statements)

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“…Westlake (1972) uses a similar approach as described here, but considers a confidence level of 1Àa, not 1À2a. Westlake (1976) also proposes an alternative (1Àa) confidence interval which is forced to be symmetric about 0; this approach is questioned by Kirkwood (1981) and answered to by Westlake (1981). Hsu, Hwang, Lui, and Ruberg (1994) as well as Berger and Hsu (1996) propose alternative confidence intervals at level 1Àa that relate to a level-a equivalence test.…”

Section: Bibliographic Notesmentioning

confidence: 99%

“…Westlake (1976) proposes a (1Àa) confidence interval which is symmetric around the mean. This approach is questioned by Kirkwood (1981) with a reply by Westlake (1981). Schuirmann (1981) was the first to propose the TOST in a short note, while a more comprehensive illustration of the TOST, its comparison to the approach of Anderson and Hauck (1983) and a discussion of the problems of the power approach can be found in Schuirmann (1987a).…”

Section: Bibliographic Notesmentioning

confidence: 99%

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Equivalence tests – A review

Meyners¹

2012

Food Quality and Preference

111

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Section: Bibliographic Notesmentioning

confidence: 99%

Section: Bibliographic Notesmentioning

confidence: 99%

Equivalence tests – A review

Meyners¹

2012

Food Quality and Preference

111

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“…The symmetry and flatness statistics from 5 to 100 MU/min tested were tested for equivalence to their respective 600 MU/min values using a paired Two One-Sided Test (TOST) by Schuirmann [16] and Westlake [17]. The robust t-test of Yuen and Dixon [18] [19] was used as it makes no assumption of normality.…”

Section: Beam Characteristic Equivalencementioning

confidence: 99%

TrueBeam Low Dose Rate Investigation for Pulsed Reduced Dose Rate IMRT

Geurts¹

2017

IJMPCERO

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The capability of the TrueBeam treatment system to deliver step and shoot IMRT plans at low dose rates was evaluated. Beam characteristics during low dose rates (5 to 100 MU/min) were evaluated for consistency using a planar ion chamber array. MU constancy, linearity, and beam profile symmetry were all found to be equivalent within 0.5%. The response of the Scandi Dos Delta 4 system was also evaluated at low dose rates of using static open beams compared to ion chamber measurements, and step and shoot IMRT plans comparing 5 -20 MU/min and 100 MU/min dose rates, with a maximum observed absolute dose difference of 0.8% and equivalence margin of 0.2%. The Gamma Index and measurement reproducibility were also found to be equivalent.

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“…Confidence interval approach for testing bio-equivalence was used by several researchers such as Meltzler [12], Westlake [13,14], Kirkwood [15], Locke [9], Chow and Shao [16], Liu [17], and Hus et al [18]. The dispute was about using ordinary confidence interval, or symmetric confidence intervals.…”

Section: Short Review Of Statistical Proceduresmentioning

confidence: 99%

Application of Information Theory to Bio-Equivalence Problem

Awad¹

2012

JBB

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The statistics of bioequivalence testing have received much attention in the literature. However, there is an ignorance of checking the validity of some of the underlying assumptions imposed on some of these tests. In this paper we review the mostly used tests. Moreover, we introduce Shannon bio-equivalence index and the concept of (1-β) 100% Shannon equivalent distributions and apply it together with a bootstrap method to test average bioequivalence of two formulations. An illustrative example is considered to compare the results of the suggested test with those that are given in the literature. The results of suggested test agree with those in the literature.

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Bioequivalence Testing -- A Need to Rethink

Cited by 172 publications

References 0 publications

Equivalence tests – A review

Equivalence tests – A review

TrueBeam Low Dose Rate Investigation for Pulsed Reduced Dose Rate IMRT

Application of Information Theory to Bio-Equivalence Problem

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