1976
DOI: 10.2307/2529259
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Symmetrical Confidence Intervals for Bioequivalence Trials

Abstract: The conventional method of setting confidence intervals for the difference of the means of two normal populations gives an interval which is not, in general, symmetrical about zero. A modification of the conventional method which leads to symmetry about zero is discussed and is recommended as particularly appropriate for use in bioequivalence trials. This modification has the effect of decreasing the "effective" length of the confidence interval, on which the decision concerning bioequivalence is based, while … Show more

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Cited by 326 publications
(189 citation statements)
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“…The multiplicative model, which looks at the ratio of means, will not be considered further in this paper. The commonly used procedure in biostatistics for this problem is to use the "two one-sided tests" procedure, or TOST (Westlake, 1976(Westlake, , 1979Schuirmann, 1981Schuirmann, , 1987. With the TOST, the researcher will consider two groups equivalent if he can show that they differ by less than some constant τ , the equivalence bound, in both directions.…”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…The multiplicative model, which looks at the ratio of means, will not be considered further in this paper. The commonly used procedure in biostatistics for this problem is to use the "two one-sided tests" procedure, or TOST (Westlake, 1976(Westlake, , 1979Schuirmann, 1981Schuirmann, , 1987. With the TOST, the researcher will consider two groups equivalent if he can show that they differ by less than some constant τ , the equivalence bound, in both directions.…”
Section: Methodsmentioning
confidence: 99%
“…Lehmann (1959) anticipated the need for interval testing in his classic volume on the theory of hypothesis testing. Many of the currently employed methods of equivalence testing were developed in the 1970's and 1980's to address biostatistical and pharmaceutical problems (Westlake, 1976(Westlake, , 1979Schuirmann, 1981Schuirmann, , 1987Anderson & Hauck, 1983;Patel & Gupta, 1984). Rogers, Howard, and Vessey (1993) introduced the use of equivalence testing methods to the social sciences.…”
Section: Introductionmentioning
confidence: 99%
“…To avoid those problems, we adopt a different decision rule, somewhat analogous to frequentist equivalence testing (e.g., Rogers, Howard, & Vessey, 1993;Westlake, 1976Westlake, , 1981. The procedure requires establishing a region of practical equivalence (ROPE) around the null value that expresses a range of parameter values that are equivalent to the null value for current practical purposes.…”
Section: Bayesian Estimation and Highest Density Intervalmentioning
confidence: 99%
“…Although interest has usually centered around the testing problem in (5.1), there is also considerable interest (and benefit) in constructing confidence intervals for p 2 -p 1 • Given a 1-a confidence interval C(x) for p 2 -p 1 , an a-level test of (5.1) can be conducted by rejecting H 0 whenever C{x) C (-6, 6), as proposed by Westlake (1972Westlake ( , 1976. (Notice that this use of confidence sets as tests is reversed from the usual use.…”
Section: Connectiods With Bioequivalencementioning
confidence: 99%