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Volumn 11, Issue 4, 1996, Pages 283-302

Bioequivalence trials, intersectio–union tests and equivalence confidence sets

Author keywords

Bioavailability; Bioequivalence; Confidence interval; Equivalence test; Hypothesis test; Intersection union; Level; Pharmacokinetic; Size; Unbiased

Indexed keywords


EID: 0043005476     PISSN: 08834237     EISSN: None     Source Type: Journal    
DOI: 10.1214/ss/1032280304     Document Type: Article
Times cited : (514)

References (61)
  • 1
    • 0002211607 scopus 로고
    • Individual bioequivalence: A problem of switchability (With discussion)
    • Anderson, S. (1993). Individual bioequivalence: a problem of switchability (with discussion). Biopharmaceutical Report 2 1-11.
    • (1993) Biopharmaceutical Report , vol.2 , pp. 1-11
    • Anderson, S.1
  • 2
    • 84947888949 scopus 로고
    • A new procedure for testing equivalence in comparative bioavailability and other clinical trials
    • Anderson, S. and Hauck, W. W. (1983). A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm. Statist. Theory Methods 12 2663-2692.
    • (1983) Comm. Statist. Theory Methods , vol.12 , pp. 2663-2692
    • Anderson, S.1    Hauck, W.W.2
  • 3
    • 4043132590 scopus 로고
    • Letter to the Editor
    • Anderson, S. and Hauck, W. W. (1985). Letter to the Editor. Biometrics 41 561-563.
    • (1985) Biometrics , vol.41 , pp. 561-563
    • Anderson, S.1    Hauck, W.W.2
  • 5
    • 84919436881 scopus 로고
    • Multiparameter hypothesis testing and acceptance sampling
    • Berger, R. L. (1982). Multiparameter hypothesis testing and acceptance sampling. Technometrics 24 295-300.
    • (1982) Technometrics 24 , pp. 295-300
    • Berger, R.L.1
  • 6
    • 0001474912 scopus 로고
    • Uniformly more powerful tests for hypotheses concerning linear inequalities and normal means
    • Berger, R. L. (1989). Uniformly more powerful tests for hypotheses concerning linear inequalities and normal means. J. Amer. Statist. Assoc. 84 192-199.
    • (1989) J. Amer. Statist. Assoc. , vol.84 , pp. 192-199
    • Berger, R.L.1
  • 8
    • 0027016074 scopus 로고
    • Expanded confidence intervals, one-sided tests, and equivalence testing
    • Bofinger, E. (1992). Expanded confidence intervals, one-sided tests, and equivalence testing. Journal of Biopharmaceutical Statistics 2 181-188.
    • (1992) Journal of Biopharmaceutical Statistics 2 , pp. 181-188
    • Bofinger, E.1
  • 9
    • 21844488686 scopus 로고
    • Optimal confidence sets, bioequivalence, and the limaçon of Pascal
    • Brown, L. D., Casella, G. and Hwang, J. T. G. (1995a). Optimal confidence sets, bioequivalence, and the limaçon of Pascal. J Amer. Statist. Assoc. 90 880-889.
    • (1995) J Amer. Statist. Assoc , vol.90 , pp. 880-889
    • Brown, L.D.1    Casella, G.2    Hwang, J.T.G.3
  • 13
    • 84982032932 scopus 로고
    • An alternative approach for the assessment of bioequivalence between two formulations of a drug
    • Chow, S.-C. and Shao, J. (1990). An alternative approach for the assessment of bioequivalence between two formulations of a drug. Biometrical J. 32 969-976.
    • (1990) Biometrical J , vol.32 , pp. 969-976
    • Chow, S.-C.1    Shao, J.2
  • 17
    • 0039159520 scopus 로고
    • Bioavailability and bioequivalence requirements
    • Chapter 320. U.S. Government Printing Office, Washington, D.C
    • FDA (1992a). Bioavailability and bioequivalence requirements. In U.S. Code of Federal Regulations 21, Chapter 320. U.S. Government Printing Office, Washington, D.C.
    • (1992) U.S. Code of Federal Regulations , vol.21
  • 18
    • 0000991825 scopus 로고
    • Some problems in interval estimation
    • Fieller, E. (1954). Some problems in interval estimation. J Roy. Statist. Soc. Ser. B 16 175-185.
    • (1954) J Roy. Statist. Soc. Ser. B , vol.16 , pp. 175-185
    • Fieller, E.1
  • 19
    • 0002114445 scopus 로고
    • The biological standardisation of insulin
    • Fieller, E. C. (1940). The biological standardisation of insulin. J. Roy. Statist. Soc. Supplement 7 1-64.
    • (1940) J. Roy. Statist. Soc. Supplement , vol.7 , pp. 1-64
    • Fieller, E.C.1
  • 23
    • 70349346412 scopus 로고
    • On the relationship between stepwise decision procedures and confidence sets
    • Hayter, A. J. and HSU, J. C. (1994). On the relationship between stepwise decision procedures and confidence sets. J. Amer. Statist. Assoc. 89 128-136.
    • (1994) J. Amer. Statist. Assoc. , vol.89 , pp. 128-136
    • Hayter, A.J.1    Hsu, J.C.2
  • 24
    • 0000210329 scopus 로고
    • Constrained two-sided simultaneous confidence intervals for multiple comparisons with the best
    • HSU, J. C. (1984). Constrained two-sided simultaneous confidence intervals for multiple comparisons with the best. Ann. Statist. 12 1136-1144.
    • (1984) Ann. Statist. , vol.12 , pp. 1136-1144
    • Hsu, J.C.1
  • 26
    • 0000224613 scopus 로고
    • Confidence intervals associated with tests for bioequivalence
    • Hsu, J. C., Hwang, J. T. G., Liu, H.-K. and Ruberg, S. J. (1994). Confidence intervals associated with tests for bioequivalence. Biometrika 81 103-114.
    • (1994) Biometrika , vol.81 , pp. 103-114
    • Hsu, J.C.1    Hwang, J.T.G.2    Liu, H.-K.3    Ruberg, S.J.4
  • 27
    • 0025111746 scopus 로고
    • Bovine growth hormone: Human food safety evaluation
    • JUSKEVICH, J. C. and Guyer, C. G. (1990). Bovine growth hormone: human food safety evaluation. Science 249 875-884.
    • (1990) Science , vol.249 , pp. 875-884
    • Juskevich, J.C.1    Guyer, C.G.2
  • 28
    • 0005256225 scopus 로고
    • Bootstrapping a bioequivalence measure
    • Kinsella, A. (1989). Bootstrapping a bioequivalence measure. The Statistician 38 175-179.
    • (1989) The Statistician , vol.38 , pp. 175-179
    • Kinsella, A.1
  • 31
    • 21844526834 scopus 로고
    • Uniformly more powerful, onesided tests for hypotheses about linear inequalities
    • Liu, H. and Berger, R. L. (1995). Uniformly more powerful, onesided tests for hypotheses about linear inequalities. Ann. Statist. 23 55-72.
    • (1995) Ann. Statist. , vol.23 , pp. 55-72
    • Liu, H.1    Berger, R.L.2
  • 32
    • 84950182824 scopus 로고
    • On the assessment of variability in bioavailability/bioequivalence studies
    • Liu, J.-P. and Chow, S.-C. (1992). On the assessment of variability in bioavailability/bioequivalence studies. Comm. Statist. Theory Methods 21 2591-2607.
    • (1992) Comm. Statist. Theory Methods , vol.21 , pp. 2591-2607
    • Liu, J.-P.1    Chow, S.-C.2
  • 33
    • 0029006314 scopus 로고
    • Bias of two one-sided tests procedures in assessment of bioequivalence
    • Liu, J.-P. and Weng, C.-S. (1995). Bias of two one-sided tests procedures in assessment of bioequivalence. Statistics in Medicine 14 853-861.
    • (1995) Statistics in Medicine , vol.14 , pp. 853-861
    • Liu, J.-P.1    Weng, C.-S.2
  • 34
    • 0021702968 scopus 로고
    • An exact confidence interval from untransformed data for the ratio of two formulation means
    • LOCKE, C. S. (1984). An exact confidence interval from untransformed data for the ratio of two formulation means. Journal of Pharmacokinetics and Biopharmaceutics 12 649-655.
    • (1984) Journal of Pharmacokinetics and Biopharmaceutics , vol.12 , pp. 649-655
    • Locke, C.S.1
  • 35
    • 0019576616 scopus 로고
    • Comparison of different methods for decision-making in bioequivalence assessment
    • MANDALLAZ, D. and Mau, J. (1981). Comparison of different methods for decision-making in bioequivalence assessment. Biometrics 20 213-222.
    • (1981) Biometrics , vol.20 , pp. 213-222
    • Mandallaz, D.1    Mau, J.2
  • 36
    • 84981986967 scopus 로고
    • On testing for bioequivalence
    • Martin AndrEs, A. (1990). On testing for bioequivalence. Biometrical J. 32 125-126.
    • (1990) Biometrical J , vol.32 , pp. 125-126
    • Martin Andres, A.1
  • 37
    • 0025774648 scopus 로고
    • Sample sizes for bioequivalence studies
    • METZLER, C. M. (1991). Sample sizes for bioequivalence studies. Statistics in Medicine 10 961-970.
    • (1991) Statistics in Medicine , vol.10 , pp. 961-970
    • Metzler, C.M.1
  • 38
    • 84981986752 scopus 로고
    • An improvement of the Westlake symmetric confidence interval
    • MUller-Cohrs, J. (1991). An improvement of the Westlake symmetric confidence interval. Biometrical J. 33 357-360.
    • (1991) Biometrical J , vol.33 , pp. 357-360
    • Muller-Cohrs, J.1
  • 39
    • 0027724856 scopus 로고
    • An improvement on commonly used tests in bioequivalence assessment
    • Munk, A. (1993). An improvement on commonly used tests in bioequivalence assessment. Biometrics 49 1225-1230.
    • (1993) Biometrics , vol.49 , pp. 1225-1230
    • Munk, A.1
  • 40
    • 84980190000 scopus 로고
    • A problem of equivalence in clinical trials
    • PATEL, H. I. and Gupta, G. D. (1984). A problem of equivalence in clinical trials. Biometrical J. 26 471-474.
    • (1984) Biometrical J , vol.26 , pp. 471-474
    • Patel, H.I.1    Gupta, G.D.2
  • 41
    • 84944400469 scopus 로고
    • Length of confidence intervals
    • PRATT, J. W. (1961). Length of confidence intervals. J. Amer. Statist. Assoc. 56 541-567.
    • (1961) J. Amer. Statist. Assoc. , vol.56 , pp. 541-567
    • Pratt, J.W.1
  • 42
    • 0021397596 scopus 로고
    • On testing for bioequivalence
    • Rocke, D. M. (1984). On testing for bioequivalence. Biometrics 40 225-230.
    • (1984) Biometrics , vol.40 , pp. 225-230
    • Rocke, D.M.1
  • 43
    • 0005044961 scopus 로고
    • Multiple comparison procedures for pooling batches in stability studies
    • Ruberg, S. J. and HSU, J. C. (1992). Multiple comparison procedures for pooling batches in stability studies. Technometrics 34 465-472.
    • (1992) Technometrics , vol.34 , pp. 465-472
    • Ruberg, S.J.1    Hsu, J.C.2
  • 44
    • 0001244494 scopus 로고
    • A test of a multivariate normal mean with composite hypotheses determined by linear inequalities
    • SASABUCHi, S. (1980). A test of a multivariate normal mean with composite hypotheses determined by linear inequalities. Biometrika 67 429-439.
    • (1980) Biometrika , vol.67 , pp. 429-439
    • Sasabuchi, S.1
  • 45
    • 0010596466 scopus 로고
    • A multivariate one-sided test with composite hypotheses when the covariance matrix is completely unknown
    • SASABUCHi, S. (1988a). A multivariate one-sided test with composite hypotheses when the covariance matrix is completely unknown. Mem. Fac. Sci. Kyushu Univ. Ser. A 42 37-46.
    • (1988) Mem. Fac. Sci. Kyushu Univ. Ser. A , vol.42 , pp. 37-46
    • Sasabuchi, S.1
  • 46
    • 0002451242 scopus 로고
    • A multivariate test with composite hypotheses determined by linear inequalities when the covariance matrix has an unknown scale factor
    • SASABUCHi, S. (1988b). A multivariate test with composite hypotheses determined by linear inequalities when the covariance matrix has an unknown scale factor. Mem. Fac. Sci. Kyushu Univ. Ser A 42 9-19.
    • (1988) Mem. Fac. Sci. Kyushu Univ. Ser A , vol.42 , pp. 9-19
    • Sasabuchi, S.1
  • 47
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • SCHALL, R. and LUSS, G. H. (1993). On population and individual bioequivalence. Statistics in Medicine 12 1109-1124.
    • (1993) Statistics in Medicine , vol.12 , pp. 1109-1124
    • Schall, R.1    Luss, G.H.2
  • 49
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 15 657-680.
    • (1987) Journal of Pharmacokinetics and Biopharmaceutics , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 50
    • 0343807243 scopus 로고
    • Confidence intervals for the ratio of two means from a crossover study
    • Amer. Statist. Assoc., Alexandria, VA
    • Schuirmann, D. J. (1989). Confidence intervals for the ratio of two means from a crossover study. In Proceedings of the Biopharmaceutical Section 121-126. Amer. Statist. Assoc., Alexandria, VA.
    • (1989) Proceedings of the Biopharmaceutical Section , pp. 121-126
    • Schuirmann, D.J.1
  • 51
    • 0000117116 scopus 로고
    • On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval
    • Schuirmann, D. L. (1981). On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval. Biometrics 37 617.
    • (1981) Biometrics , vol.37 , pp. 617
    • Schuirmann, D.L.1
  • 52
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • Sheiner, L. B. (1992). Bioequivalence revisited. Statistics in Medicine 11 1777-1788.
    • (1992) Statistics in Medicine , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1
  • 53
    • 0002427627 scopus 로고
    • On confidence sets in multiple comparisons
    • S. S. Gupta and J. O. Berger, eds, Springer, New York
    • Stefansson, G., Kim, W. C. and HSU, J. C. (1988). On confidence sets in multiple comparisons. In Statistical Decision Theory and Related Topics TV (S. S. Gupta and J. O. Berger, eds.) 2 89-104. Springer, New York.
    • (1988) Statistical Decision Theory and Related Topics TV , vol.2 , pp. 89-104
    • Stefansson, G.1    Kim, W.C.2    Hsu, J.C.3
  • 56
    • 0017028729 scopus 로고
    • Symmetric confidence intervals for bioequivalence trials
    • WESTLAKE, W. J. (1976). Symmetric confidence intervals for bioequivalence trials. Biometrics 32 741-744.
    • (1976) Biometrics , vol.32 , pp. 741-744
    • Westlake, W.J.1
  • 57
    • 0001305791 scopus 로고
    • Response to T.B.L. Kirkwood: Bioequivalence testing-a need to rethink
    • WESTLAKE, W. J. (1981). Response to T.B.L. Kirkwood: bioequivalence testing-a need to rethink. Biometrics 37 589-594.
    • (1981) Biometrics , vol.37 , pp. 589-594
    • Westlake, W.J.1
  • 58
    • 0000470568 scopus 로고
    • Bioavailability and bioequivalence of pharmaceutical formulations
    • Karl E. Peace, ed.), Dekker, New York
    • WESTLAKE, W. J. (1988). Bioavailability and bioequivalence of pharmaceutical formulations. In Biopharmaceutical Statistics for Drug Development (Karl E. Peace, ed.) 329-352. Dekker, New York.
    • (1988) Biopharmaceutical Statistics for Drug Development , pp. 329-352
    • Westlake, W.J.1
  • 59
    • 85038293200 scopus 로고
    • An extended two one-sided tests procedure
    • Amer. Statist. Assoc., Alexandria, VA
    • Yang, H.-M. (1991). An extended two one-sided tests procedure. In Proceedings of the Biopharmaceutical Section 157-162. Amer. Statist. Assoc., Alexandria, VA.
    • (1991) Proceedings of the Biopharmaceutical Section , pp. 157-162
    • Yang, H.-M.1
  • 60
    • 0023021373 scopus 로고
    • The calculation of probabilities in rejecting bioequivalence
    • Yee, K. F. (1986). The calculation of probabilities in rejecting bioequivalence. Biometrics 42 961-965.
    • (1986) Biometrics , vol.42 , pp. 961-965
    • Yee, K.F.1
  • 61
    • 85038332459 scopus 로고
    • Correspondence to the Editor
    • Yee, K. F. (1990). Correspondence to the Editor. The Statistician 39 465-466.
    • (1990) The Statistician , vol.39 , pp. 465-466
    • Yee, K.F.1


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