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Why is 90% Confidence Interval Used When Confidence Interval Approach is Used for Testing Equivalence?
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 Title & Authors
Why is 90% Confidence Interval Used When Confidence Interval Approach is Used for Testing Equivalence?
Kang, Seung-Ho;
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It is a convention to use 5% significance level when a statistical test is employed for clinical data. But when a confidence interval is used for testing equivalence, 90% confidence interval has often been used. When confidence interval is used for hypothesis testing, its significance level is often . So it makes a confusion that the significance level is 10% if 90% confidence interval is employed for testing equivalence. In this paper I will clarify this issue by reviewing relevant papers and conducting simulation studies. I hope that it will be beneficial to statisticians in pharmaceutical companies, CROs, university hospitals.
Bioequivalence;intersection union test;two one-sided tests;
 Cited by
생물학적 동등성 시험의 신뢰구간 비교,김현정;엄정국;임광규;이관제;

Journal of the Korean Data Analysis Society, 2013. vol.15. 5B, pp.2429-2443
Bio-Equivalence Analysis using Linear Mixed Model, Korean Journal of Applied Statistics, 2015, 28, 2, 289  crossref(new windwow)
권광옥, 김옥희, 김종국, 김주일, 배균섭, 사홍기, 이용복, 이화정, 최선옥 (2006). <생물학적 동등성의 이해>, 신일상사

식품의약품안전청 (2005). 고시 제 2005-31호 생물학적 동등성시험기준

Berger, R. L. and Hsu, J. C. (1996). Bioequivalence trials, intersection union-tests and equivalence confidence sets (with discussion), Statistical Science, 11, 283-319 crossref(new window)

Chow, S. C. and Liu, J. P. (2000). Design and Analysis of Bioevailability and Bioequivalence Studies, 2nd edition, Marcel Dekker, New York

Chow, S. C. and Shao, J. (2002). Statistics in Drug Research: Methodologies and Recent Developments, Marcel Dekker, New York

FDA (1992). Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland

Hsu, J. C. (1984). Constrained simultaneous confidence intervals for multiple comparisons with the best, The Annals of Statistics, 12, 1136-1144 crossref(new window)

ICH (1998). Statistical principles for clinical trials, Tripartite International Conference on Harmonization Guideline, E9

Lehmann, E. L. (1986). Testing Statistical Hypotheses, 2nd edition, John Wiley & Sons, New York

Liu, H. K. (1990). Confidence intervals in bioequivalence assessment, In Proceedings of the Biopharmaceutical Section of the American Statistical Association, 51-54

Westlake, W. J. (1976). Symmetric confidence intervals for bioequivalence trials, Biometrics, 32, 741-744 crossref(new window)