BioequivalenceBiblio.doc
© 2004, Timothy G. Gregoire, Yale University
Last Revised, 4 March 2006
BIOEQUIVALENCE BIBLIOGRAPHY
1954-Present
1. Hodges, J. L. & E. L. Lehman. (1954) Testing the approximate validity of statistical
hypotheses. Journal of the Royal Statistical Society, Series B. 16(2) 261-268.
2. Westlake, W.J. (1976) Symmetrical confidence intervals for bioequivalence trials.
Biometrics, 32: 741-744.
3. Dunnett, C. W. & M. Gent. (1977) Significance testing to establish equivalence between
treatments, with special reference to data in the form of 2×2 tables. Biometrics 33: 593602.
4. Westlake, W.J. (1979) Statistical aspects of comparative bioavailability trials.
Biometrics, 35: 273-280.
5. Kirkwood, T.B.L. (1981) Bioequivalence testing—a need to rethink. Biometrics, 37:
589-594.
6. Mandallaz, D. and J. Mau. (1981) Comparison of different methods for decision-making
in bioequivalence assessment. Biometrics, 37: 213-222.
7. Anderson, S. and W.W. Hauck. (1983) A new procedure for testing equivalence in
comparative bioavailability and other clinical trials. Communications Statistics,
Theory, and Methods, 12(23): 2663-2692.
8. Patel, H.I. and G.D. Gupta. (1984) A problem of equivalence in clinical trials.
Biometrical Journal, 26(5): 471-474.
9. Rocke, D.M. (1984) On testing for bioequivalence. Biometrics, 40: 225-230.
10. Bross, I.D. (1985) Why proof of safety is much more difficult than proof of hazard.
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11. McClure, J.P., J. Anderson, and H.T. Schreuder. (1987) A comparison of regional and
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13. Schuirmann, D.J. (1987) A comparison of the two one-sided tests procedure and the
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14. Johnson, R. (1988). P-values in 2×2 tables. Biometrics 44: 907-910. (includes reply by
Dunnett and Gent).
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BioequivalenceBiblio.doc
© 2004, Timothy G. Gregoire, Yale University
15. Chow, S.-C. and J. Shao. (1990) An alternative approach for the assessment of
bioequivalence between two formulations of a drug. Biometrical Journal, 32(3): 969976.
16. Chow, S.-C. and J.-P. Liu. (1990) Design and analysis of bioavailability and
bioequivalence studies. Marcel Dekker, Inc., New York.
17. Hsuan, F.C. (1993) Estimating treatment means in a mixed-effort ANOVA model for
bioequivalence studies. Biometrics, 49(3): 703-713.
18. Rogers, J.L., K.I. Howard, and J.T. Vessey. (1993) Using significance tests to evaluate
equivalence between two experimental groups. Psychological Bulletin, 113(3): 553-565.
19. Frick, H. (1994) On approximate and exact sample sizes of equivalence tests for
binomial proportions. Biometrical Journal, 36(7): 841-854.
20. Huh, M.-H. (1994) Equivalence testing as an alternative to significance testing. Journal
of Korean Statistical Society, 23(1): 199-206.
21. McDonald, L.L. and W.P. Erickson. (1994) Testing for bioequivalence in field studies:
Has a disturbed site been adequately reclaimed? Statistics in Ecology and Environmental Monitoring, pages 183-197.
22. Erickson, W.P. and L.L. McDonald. (1995) Tests for bioequivalence of control media
and test media in studies of toxicity. Environmental Toxicology and Chemistry, 14(7):
1247-1256.
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equivalence confidence sets. Statistical Science, 11(4): 283-319.
24. Dixon, P.M. (1998) 12: Assessing effect and no effect with equivalence tests. In Risk
Assessment: Logic and Measurement, M.C. Newman and C.L. Strojan eds., Ann Arbor
Press, Chelsea, Michigan, pages 275-301.
25. Lindley, D.V. (1998) Decision analysis and bioequivalence trials. Statistical Science,
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26. Krantz, D.H. (1999) The null hypothesis testing controversy in psychology. Journal of
the American Statistical Association, 94: 1372-1381.
27. McBride, G.B. (1999) Equivalence tests can enhance environmental science and
management. Australian & New Zealand Journal of Statistics, 41(1): 19-29.
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28. Murphy, K. R. & B. Myors. (1999) Testing the hypothesis that treatments have negligible
effects: minimum-effect tests in the general linear model. Journal of Applied
Psychology 84(2) 234-248.
29. Munk, A. & R. Pflüger. (1999) 1−α equivariant confidence rules for convex alternatives
are α /2-level tests – with applications to the multivariate assessment of bioequivalence.
Journal of the American Statistical Association 94: 1311-1319.
30. Perlman, M.D. and L. Wu. (1999) The Emperor’s new tests. Statistical Science, 14(4):
355-381.
31. Anderson, D.R., K.P. Burnham, and W.L. Thompson. (2000) Null hypothesis testing:
problems, prevalence, and an alternative. Journal of Wildlife Management, 64(4): 912923.
32. Gould, A.L. (2000) A practical approach for evaluating population and individual
bioequivalence. Statistics in Medicine, 19: 2721-2740.
33. Kimanani, E.K. (2000) Definition of individual bioequivalence: occasion-to-occasion
versus mean switchability. Statistics in Medicine, 19: 2797-2810.
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Statistical Medicine, 19: 2843-2854.
35. Shao, J., S.-C. Chow, and B. Wang. (2000) The bootstrap procedure in individual
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36. Zariffa, N. M.-D., S.D. Patterson, D. Boyle, and M. Hynek. (2000) Case studies,
practical issues and observing population and individual bioequivalence. Statistics in
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37. Anderson, D.R., W.A. Link, D.H. Johnson, K.P. Burnham. (2001) Suggestions for
presenting the results of data analyses. Journal of Wildlife Management, 65(3): 373378.
38. Barker, L., H. Rolka, D. Rolka, and C. Brown. (2001) Equivalence testing for binomial
random variables: which test to use? The American Statistician, 55(4): 279-287.
39. Burnham, K.P. and D.R. Anderson. (2001) Kullback-Leibler information as a basis for
strong inference in ecological studies. Wildlife Research, 28: 111-119.
40. Hoenig, J. M. & D. M. Heisey. (2001) The abuse of power: the pervasive fallacy of
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41. Lenth, R.V. (2001) Some practical guidelines for effective sample size determination.
The American Statistician, 55(3): 187-193.
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42. Parkhurst, D.F. (2001) Statistical significance tests: equivalence and reverse tests should
reduce misinterpretation. BioScience, 51(12):1051-1057.
43. Quan, H., J. Bolognese, and W. Yuan. (2001) Assessment of equivalence on multiple
endpoints. Statistics in Medicine, 20: 3259-3173.
44. Thompson, B. (2001) Significance, effect sizes, stepwise methods, and other issues:
Strong arguments move the field. Journal of Experimental Education, 70(1): 80-93.
45. Andres, A.M. and I.H. Tejedor. (2002) Barker, L., Rolka, H., Rolka, D., and Brown, C.
(2001), ‘Equivalence testing for binomial random variables: which test to use?’ The
American Statistician, 55, 279-287: Comment by Martin Andres and Herrand Tejedor
and reply. The American Statistician, 56(3): 253.
46. Blair, R.C. and S.R. Cole. (2002) Two-sided equivalence testing of the difference
between two means. Journal of Modern Applied Statistical Methods, 1(1): 139-142.
47. Lin, L., A. S. Hedayat, B. Sinha, & M. Yang. (2002) Statistical methods in assessing
agreement: models, issues, and tools. Journal of the American Statistical Association
97: 257-270.
48. Sawilowsky, S. S. and J. S. Yoon (2002) The trouble with trivials (p>.05), Journal of
Modern Applied Statistical Methods, 1(1): 143-144.
49. Wu, J., G. Jiang, A.C.M. Wong, and X. Sun. (2002) Likelihood analysis for the ratio of
means of two independent log-normal distributions. Biometrics, 58: 463-469.
50. Mecklin, C.J. (2003) A comparison of equivalence testing in combination with
hypothesis testing and effect sizes. Journal of Modern Applied Statistical Methods,
2(2): 329-340.
51. Wellek, S. (2003). Testing Statistical Hypotheses of Equivalence. Boca Raton: Chapman
& Hall/CRC. 284 pp.
52. Andrés, A. M. and I. H. Tejedor. (2004) The equivalence of two proportions revisited.
Journal of Applied Statistics 31(1) 61-72.
53. Bickel, D. R. (2004) Degrees of differential gene expression: detecting biologically
significant expression differences and estimating their magnitudes. Bioinformatics
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54. Manly, B. F. (2004) One-sided tests of bioequivalence with nonnormal distributions and
unequal variances. Journal of Agricultural, Biological, and Environmental Statistics
9(3) 270-283.
55. Robinson, A.P. and R.E. Froese. (2004) Model validation using equivalence tests.
Ecological Modelling 176: 349-358.
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56. Robinson, A. P., R. A. Duursma, & J. D. Marshall. (2005) A regression-based
equivalence test for model validation: shifting the burden of proof. Tree Physiology 25:
903-913.
57. Moerkerke, B., E. Goetghebeur, J DeRiek, and I. Roldán-Ruiz. (2006) Significance and
impotence: towards a balanced view of the null and alternative hypotheses in marker
selection for plant breeding.
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