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Volumn , Issue , 2010, Pages 1-403

TESTING STATISTICAL HYPOTHESES OF EQUIVALENCE AND NONINFERIORITY: SECOND EDITION

(1)  Wellek, Stefan a  

a NONE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85152844632     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/EBK1439808184     Document Type: Book
Times cited : (438)

References (206)
  • 3
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman, D.G. and Bland, J.M. (1995) Absence of evidence is not evidence of absence. British Medical Journal 311: 485.
    • (1995) British Medical Journal , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 5
    • 0001646484 scopus 로고
    • Cox’s regression model for counting processes: A large sample study
    • Andersen, P.K. and Gill, R.D. (1982) Cox’s regression model for counting processes: A large sample study. Annals of Statistics 10: 1100-20.
    • (1982) Annals of Statistics , vol.10 , pp. 1100-1120
    • Andersen, P.K.1    Gill, R.D.2
  • 6
    • 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. Communications in Statistics: Theory and Methods 12: 2663-92.
    • (1983) Communications in Statistics: Theory and Methods , vol.12 , pp. 2663-2692
    • Anderson, S.1    Hauck, W.W.2
  • 9
    • 0000937686 scopus 로고
    • Tests for linear trends in proportions and frequencies
    • Armitage, P. (1955) Tests for linear trends in proportions and frequencies. Biometrics 11: 375-86.
    • (1955) Biometrics , vol.11 , pp. 375-386
    • Armitage, P.1
  • 10
    • 0029119268 scopus 로고
    • Prospective randomized trial of chemotherapy given before radiotherapy in childhood medulloblastoma. International Society of Paediatric Oncology SIOP and the German Society of Paediatric Oncology GPO: SIOP II
    • Bailey, C.C., Gnekow, A., Wellek, S., Jones, M., Round, C., Brown, J., Philips, A. and Neidhardt, M.K. (1995) Prospective randomized trial of chemotherapy given before radiotherapy in childhood medulloblastoma. International Society of Paediatric Oncology SIOP and the German Society of Paediatric Oncology GPO: SIOP II. Medical Pediatric Oncology 25: 166-78.
    • (1995) Medical Pediatric Oncology , vol.25 , pp. 166-178
    • Bailey, C.C.1    Gnekow, A.2    Wellek, S.3    Jones, M.4    Round, C.5    Brown, J.6    Philips, A.7    Neidhardt, M.K.8
  • 11
    • 84872639295 scopus 로고
    • Significance tests for 2x2 tables
    • Barnard, G.A. (1947) Significance tests for 2x2 tables. Biometrika 34: 123-38.
    • (1947) Biometrika , vol.34 , pp. 123-138
    • Barnard, G.A.1
  • 13
    • 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 , vol.24 , pp. 295-300
    • Berger, R.L.1
  • 14
  • 15
    • 0043005476 scopus 로고    scopus 로고
    • Bioequivalence trials, intersection-union tests and equivalence confidence sets
    • Berger, R.L. and Hsu, J.C. (1996) Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science 11: 283-319.
    • (1996) Statistical Science , vol.11 , pp. 283-319
    • Berger, R.L.1    Hsu, J.C.2
  • 16
    • 0037343359 scopus 로고    scopus 로고
    • Exact unconditional tests for a 2×2 matched pairs design
    • Berger, R.L. and Sidik, K. (2003) Exact unconditional tests for a 2×2 matched pairs design. Statistical Methods in Medical Research 12: 91-108.
    • (2003) Statistical Methods in Medical Research , vol.12 , pp. 91-108
    • Berger, R.L.1    Sidik, K.2
  • 19
    • 0020308864 scopus 로고
    • Proving the null hypothesis” in clinical trials
    • Blackwelder, W.C. (1982) “Proving the null hypothesis” in clinical trials. Controlled Clinical Trials 3: 345-53.
    • (1982) Controlled Clinical Trials , vol.3 , pp. 345-353
    • Blackwelder, W.C.1
  • 20
    • 0027253889 scopus 로고
    • Sample size and power for prospective analysis of relative risk
    • Blackwelder, W.C. (1993) Sample size and power for prospective analysis of relative risk. Statistics in Medicine 12: 691-8.
    • (1993) Statistics in Medicine , vol.12 , pp. 691-698
    • Blackwelder, W.C.1
  • 21
    • 0040646365 scopus 로고
    • A test of an experimental hypothesis of negligible difference between means
    • Bondy, W.H. (1969) A test of an experimental hypothesis of negligible difference between means. The American Statistician 23: 28-30.
    • (1969) The American Statistician , vol.23 , pp. 28-30
    • Bondy, W.H.1
  • 22
    • 84987224470 scopus 로고
    • Raised conditional level of significance for the 2 × 2- table when testing the equality of two probabilities
    • Boschloo, R.D. (1970) Raised conditional level of significance for the 2 × 2- table when testing the equality of two probabilities. Statistica Neerlandica 24: 1-35.
    • (1970) Statistica Neerlandica , vol.24 , pp. 1-35
    • Boschloo, R.D.1
  • 24
    • 0018987266 scopus 로고
    • The crossover experiment for clinical trials
    • Brown, B.W. (1980) The crossover experiment for clinical trials. Biometrics 36: 69-79.
    • (1980) Biometrics , vol.36 , pp. 69-79
    • Brown, B.W.1
  • 25
    • 0039269080 scopus 로고    scopus 로고
    • An unbiased test for the bioequivalence problem
    • Brown, L.D., Hwang, J.T.G. and Munk, A. (1997) An unbiased test for the bioequivalence problem. Annals of Statistics 25: 2345-67.
    • (1997) Annals of Statistics , vol.25 , pp. 2345-2367
    • Brown, L.D.1    Hwang, J.T.G.2    Munk, A.3
  • 26
    • 84921386393 scopus 로고
    • Reconciling bayesian and frequentist evidence in one-sided testing problems
    • Casella, G. and Berger, R.L. (1987) Reconciling bayesian and frequentist evidence in one-sided testing problems. Journal of the American Statistical Association 82: 106-11.
    • (1987) Journal of the American Statistical Association , vol.82 , pp. 106-111
    • Casella, G.1    Berger, R.L.2
  • 27
    • 0032581130 scopus 로고    scopus 로고
    • Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies
    • Chan, I.S.F. (1998) Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies. Statistics in Medicine 17: 1403-13.
    • (1998) Statistics in Medicine , vol.17 , pp. 1403-1413
    • Chan, I.S.F.1
  • 28
    • 0037280386 scopus 로고    scopus 로고
    • Proving non-inferiority or equivalence of two treatments with dichotomous endpoints using exact methods
    • Chan, I.S.F. (2003) Proving non-inferiority or equivalence of two treatments with dichotomous endpoints using exact methods. Statistical Methods in Medical Research 12: 37-58.
    • (2003) Statistical Methods in Medical Research , vol.12 , pp. 37-58
    • Chan, I.S.F.1
  • 29
    • 0032756788 scopus 로고    scopus 로고
    • Test-based exact confidence intervals for the difference of two binomial proportions
    • Chan, I.S.F. and Zhang, Z. (1999) Test-based exact confidence intervals for the difference of two binomial proportions. Biometrics 55: 1202-9.
    • (1999) Biometrics , vol.55 , pp. 1202-1209
    • Chan, I.S.F.1    Zhang, Z.2
  • 30
    • 0030949859 scopus 로고    scopus 로고
    • Individual bioequivalence - A regulatory update
    • Chen, M.L. (1997) Individual bioequivalence - A regulatory update. Journal of Biopharmaceutical Statistics 7: 5-11.
    • (1997) Journal of Biopharmaceutical Statistics , vol.7 , pp. 5-11
    • Chen, M.L.1
  • 31
    • 0343671149 scopus 로고
    • Review of equivalence and hypothesis testing
    • Washington: American Statistical Association, 177-82
    • Chester, S.T. (1986) Review of equivalence and hypothesis testing. In ASA Proceedings of the Biopharmaceutical Section. Washington: American Statistical Association, 177-82.
    • (1986) ASA Proceedings of the Biopharmaceutical Section
    • Chester, S.T.1
  • 34
    • 0000665540 scopus 로고
    • Some problems connected with statistical inference
    • Cox, D.R. (1958) Some problems connected with statistical inference. Annals of Mathematical Statistics 29: 357-72.
    • (1958) Annals of Mathematical Statistics , vol.29 , pp. 357-372
    • Cox, D.R.1
  • 37
    • 0005337990 scopus 로고
    • An extension of Welch’s approximate t-solution to comparative bioequivalence trials
    • Dannenberg, O., Dette, H. and Munk, A. (1994) An extension of Welch’s approximate t-solution to comparative bioequivalence trials. Biometrika 81: 91-101.
    • (1994) Biometrika , vol.81 , pp. 91-101
    • Dannenberg, O.1    Dette, H.2    Munk, A.3
  • 40
    • 0032714352 scopus 로고    scopus 로고
    • Genomic control for association studies
    • Devlin, B. and Roeder, K. (1999) Genomic control for association studies. Biometrics 55: 997-1004.
    • (1999) Biometrics , vol.55 , pp. 997-1004
    • Devlin, B.1    Roeder, K.2
  • 41
    • 0017643592 scopus 로고
    • Significance testing to establish equivalence between treatments, with special reference to data in the form of 2× 2 tables
    • Dunnett, C.W. and Gent, M. (1977) Significance testing to establish equivalence between treatments, with special reference to data in the form of 2× 2 tables. Biometrics 33: 593-602.
    • (1977) Biometrics , vol.33 , pp. 593-602
    • Dunnett, C.W.1    Gent, M.2
  • 42
    • 85152855863 scopus 로고    scopus 로고
    • CPMP/ICH/363/96
    • EMEA (1998) CPMP/ICH/363/96. http://www.emea.europa.eu/pdfs/human/ich/03636en.pdf9.
    • (1998)
  • 43
    • 85152834308 scopus 로고    scopus 로고
    • CPMP/EWP/2158/99
    • EMEA (2005) CPMP/EWP/2158/99. http://www.emea.europa.eu/pdfs/human/ewp/21589en.pdf9.
    • (2005)
  • 44
    • 0025633361 scopus 로고
    • Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unit relative risk
    • Farrington, C.P. and Manning, G. (1990) Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unit relative risk. Statistics in Medicine 9: 1447-54.
    • (1990) Statistics in Medicine , vol.9 , pp. 1447-1454
    • Farrington, C.P.1    Manning, G.2
  • 52
    • 85152807192 scopus 로고    scopus 로고
    • Food and Drug Administration FDA (2008) Orange Book, Version 12/2008. http://www.fda.gov/cder/orange/obreadme.htm.
    • (2008) Orange Book, Version 12/2008
  • 53
    • 0024845507 scopus 로고
    • The performance of the two-stage analysis of two treatment, two period crossover trials
    • Freeman, P. (1989) The performance of the two-stage analysis of two treatment, two period crossover trials. Statistics in Medicine 8: 1421-32.
    • (1989) Statistics in Medicine , vol.8 , pp. 1421-1432
    • Freeman, P.1
  • 54
    • 15244360717 scopus 로고    scopus 로고
    • Methods for assessing noninferiority with censored data
    • Freitag, G. (2005) Methods for assessing noninferiority with censored data. Biometrical Journal 47: 88-98.
    • (2005) Biometrical Journal , vol.47 , pp. 88-98
    • Freitag, G.1
  • 55
    • 33645469139 scopus 로고    scopus 로고
    • Non-parametric assessment of non-inferiority with censored data
    • Freitag, G., Lange, S. and Munk, A. (2006) Non-parametric assessment of non-inferiority with censored data. Statistics in Medicine 25: 1201-17.
    • (2006) Statistics in Medicine , vol.25 , pp. 1201-1217
    • Freitag, G.1    Lange, S.2    Munk, A.3
  • 56
    • 0039895091 scopus 로고
    • On level and power of Anderson and Hauck’s procedure for testing equivalence in comparative bioavailability trials
    • Frick, H. (1987) On level and power of Anderson and Hauck’s procedure for testing equivalence in comparative bioavailability trials. Communications in Statistics, Theory and Methods 16: 2771-8.
    • (1987) Communications in Statistics, Theory and Methods , vol.16 , pp. 2771-2778
    • Frick, H.1
  • 57
    • 0002445912 scopus 로고
    • Some general results on least favorable parameter configurations with special reference to equivalence testing and the range statistic
    • Giani, G. and Finner, H. (1991) Some general results on least favorable parameter configurations with special reference to equivalence testing and the range statistic. Journal of Statistical Planning and Inference 28: 33-47.
    • (1991) Journal of Statistical Planning and Inference , vol.28 , pp. 33-47
    • Giani, G.1    Finner, H.2
  • 58
    • 85152844314 scopus 로고    scopus 로고
    • Diabetesforschungsinstitut an der Heinrich-Heine-Universität, Abt. Biometrie and Epidemiologie, Düsseldorf, Germany
    • Giani, G., Strasburger, K. and Seefeldt, F. (2005) SeParATe, Version 3.0B. Diabetesforschungsinstitut an der Heinrich-Heine-Universität, Abt. Biometrie and Epidemiologie, Düsseldorf, Germany.
    • (2005) SeParATe, Version 3.0B.
    • Giani, G.1    Strasburger, K.2    Seefeldt, F.3
  • 59
    • 70350686160 scopus 로고    scopus 로고
    • Adapting the logical basis of tests for Hardy-Weinberg equilibrium to the real needs of association studies in human and medical genetics
    • Goddard, K.A.B., Ziegler, A. and Wellek, S. (2009) Adapting the logical basis of tests for Hardy-Weinberg equilibrium to the real needs of association studies in human and medical genetics. Genetic Epidemiology 33: 569-80.
    • (2009) Genetic Epidemiology , vol.33 , pp. 569-580
    • Goddard, K.A.B.1    Ziegler, A.2    Wellek, S.3
  • 60
    • 70449541670 scopus 로고
    • The two-period change-over design and its use in clinical trials
    • Grizzle, J.E. (1965) The two-period change-over design and its use in clinical trials. Biometrics 21: 467-80.
    • (1965) Biometrics , vol.21 , pp. 467-480
    • Grizzle, J.E.1
  • 61
    • 21144462871 scopus 로고
    • Exact inference about the within-subject variability in 2×2 crossover trials
    • Guilbaud, O. (1993) Exact inference about the within-subject variability in 2×2 crossover trials. Journal of the American Statistical Association 88:939-46.
    • (1993) Journal of the American Statistical Association , vol.88 , pp. 939-946
    • Guilbaud, O.1
  • 65
    • 0001442552 scopus 로고
    • Properties of the extended hypergeometric distribution
    • Harkness, W.L. (1965) Properties of the extended hypergeometric distribution. Annals of Mathematical Statistics 36: 938-45.
    • (1965) Annals of Mathematical Statistics , vol.36 , pp. 938-945
    • Harkness, W.L.1
  • 66
    • 85011149709 scopus 로고    scopus 로고
    • Comment on “Bioequivalence trials, intersection-union tests and equivalence confidence sets
    • Hauck, W.W. and Anderson, S. (1996) Comment on “Bioequivalence trials, intersection-union tests and equivalence confidence sets.” Statistical Science 11: 303.
    • (1996) Statistical Science , vol.11 , pp. 303
    • Hauck, W.W.1    Anderson, S.2
  • 69
    • 0343116955 scopus 로고    scopus 로고
    • A note on Welch’s approximate t-solution to bioequivalence assessment
    • Hauschke, D., Steinijans, V.W. and Hothorn, L.A. (1996) A note on Welch’s approximate t-solution to bioequivalence assessment. Biometrika 83:236-7.
    • (1996) Biometrika , vol.83 , pp. 236-237
    • Hauschke, D.1    Steinijans, V.W.2    Hothorn, L.A.3
  • 73
    • 0001474373 scopus 로고
    • Moment-based criteria for determining bioequivalence
    • Holder, D.J. and Hsuan, F. (1993) Moment-based criteria for determining bioequivalence. Biometrika 80: 835-46.
    • (1993) Biometrika , vol.80 , pp. 835-846
    • Holder, D.J.1    Hsuan, F.2
  • 74
    • 0024442454 scopus 로고
    • Verapamil versus hydrochlorothiazide for the treatment of hypertension. Results of a long-term double-blind comparative trial
    • Holzgreve, H., Distler, A., Michaelis, J., Philipp, T. and Wellek, S. (1989) Verapamil versus hydrochlorothiazide for the treatment of hypertension. Results of a long-term double-blind comparative trial. British Medical Journal 299: 881-6.
    • (1989) British Medical Journal , vol.299 , pp. 881-886
    • Holzgreve, H.1    Distler, A.2    Michaelis, J.3    Philipp, T.4    Wellek, S.5
  • 75
  • 76
    • 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: 103-14.
    • (1994) Biometrika , vol.81 , pp. 103-114
    • Hsu, J.C.1    Hwang, J.T.G.2    Liu, H.K.3    Ruberg, S.J.4
  • 77
    • 0035009459 scopus 로고    scopus 로고
    • Unconditional exact tests for equivalence or noninferiority for paired binary endpoints
    • Hsueh, H.M., Liu, J.P. and Chen, J.J. (2001) Unconditional exact tests for equivalence or noninferiority for paired binary endpoints. Biometrics 57:478-83.
    • (2001) Biometrics , vol.57 , pp. 478-483
    • Hsueh, H.M.1    Liu, J.P.2    Chen, J.J.3
  • 78
    • 0043233711 scopus 로고    scopus 로고
    • Testing nonparametric statistical functionals with application to rank tests
    • Janssen, A. (1999) Testing nonparametric statistical functionals with application to rank tests. Journal of Statistical Planning and Inference 81:71-93.
    • (1999) Journal of Statistical Planning and Inference , vol.81 , pp. 71-93
    • Janssen, A.1
  • 79
    • 23744478551 scopus 로고    scopus 로고
    • Nonparametric bioequivalence tests for statistical functionals and their efficient power functions
    • Janssen, A. (2000) Nonparametric bioequivalence tests for statistical functionals and their efficient power functions. Statistics and Decisions 18:49-78.
    • (2000) Statistics and Decisions , vol.18 , pp. 49-78
    • Janssen, A.1
  • 80
    • 85152854700 scopus 로고    scopus 로고
    • Exact linear rank tests for two-sample equivalence problems with continuous data
    • University of Duesseldorf, Düsseldorf, Germany
    • Janssen, A. andWellek, S. (2008) Exact linear rank tests for two-sample equivalence problems with continuous data. In Technical Report. University of Duesseldorf, Düsseldorf, Germany.
    • (2008) Technical Report
    • Janssen, A.1    Wellek, S.2
  • 82
    • 60549083544 scopus 로고    scopus 로고
    • An open access database of genomewide association results
    • Johnson, A.D. and O’Donnell, C.J. (2009) An open access database of genomewide association results. BMC Medical Genetics 10: 6.
    • (2009) BMC Medical Genetics , vol.10 , pp. 6
    • Johnson, A.D.1    O’Donnell, C.J.2
  • 91
    • 0000261317 scopus 로고
    • Decision theory for Polya type distributions. Case of two actions, I
    • J. Neyman, ed, Berkeley, CA: California University Press
    • Karlin, S. (1956) Decision theory for Polya type distributions. Case of two actions, I. In J. Neyman, ed., Proceedings of the Third Berkeley Symposium on Mathematical Statistics and Probability. Berkeley, CA: California University Press., 115-28.
    • (1956) Proceedings of the Third Berkeley Symposium on Mathematical Statistics and Probability , pp. 115-128
    • Karlin, S.1
  • 93
    • 0008904740 scopus 로고
    • Polya type distributions, III: Admissibility for multi-action problems
    • Karlin, S. (1957b) Polya type distributions, III: Admissibility for multi-action problems. Annals of Mathematical Statistics 28: 839-60.
    • (1957) Annals of Mathematical Statistics , vol.28 , pp. 839-860
    • Karlin, S.1
  • 97
    • 0032531910 scopus 로고    scopus 로고
    • Assessing screening tests: Extensions of McNemars’s test
    • Lachenbruch, P.A. and Lynch, C.J. (1998) Assessing screening tests: extensions of McNemars’s test. Statistics in Medicine 17: 2207-17.
    • (1998) Statistics in Medicine , vol.17 , pp. 2207-2217
    • Lachenbruch, P.A.1    Lynch, C.J.2
  • 100
    • 0001370087 scopus 로고
    • Nonparametric confidence intervals for a shift parameter
    • Lehmann, E.L. (1963) Nonparametric confidence intervals for a shift parameter. Annals of Mathematical Statistics 34: 1507-12.
    • (1963) Annals of Mathematical Statistics , vol.34 , pp. 1507-1512
    • Lehmann, E.L.1
  • 105
    • 33847451999 scopus 로고
    • Testing the equality of two independent binomial proportions
    • Little, R.J.A. (1989) Testing the equality of two independent binomial proportions. The American Statistician 43: 283-8.
    • (1989) The American Statistician , vol.43 , pp. 283-288
    • Little, R.J.A.1
  • 106
    • 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. Communications in Statistics: Theory and Methods 21: 2591-607.
    • (1992) Communications in Statistics: Theory and Methods , vol.21 , pp. 2591-2607
    • Liu, J.P.1    Chow, S.C.2
  • 107
    • 48249111577 scopus 로고    scopus 로고
    • A new exact and more powerful unconditional test of no treatment effect from binary matched pairs
    • Lloyd, C.J. (2008a) A new exact and more powerful unconditional test of no treatment effect from binary matched pairs. Biometrics 64: 716-23.
    • (2008) Biometrics , vol.64 , pp. 716-723
    • Lloyd, C.J.1
  • 108
    • 49749112480 scopus 로고    scopus 로고
    • Exact P-values for discrete models obtained by estimation and maximisation
    • Lloyd, C.J. (2008b) Exact P-values for discrete models obtained by estimation and maximisation. Australian and New Zealand Journal of Statistics 50:329-45.
    • (2008) Australian and New Zealand Journal of Statistics , vol.50 , pp. 329-345
    • Lloyd, C.J.1
  • 109
    • 48249136982 scopus 로고    scopus 로고
    • A more powerful exact test of noninferiority from binary matched pairs data
    • Lloyd, C.J. and Moldovan, M.V. (2008) A more powerful exact test of noninferiority from binary matched pairs data. Statistics in Medicine 27:3540-9.
    • (2008) Statistics in Medicine , vol.27 , pp. 3540-3549
    • Lloyd, C.J.1    Moldovan, M.V.2
  • 110
    • 0029098036 scopus 로고
    • On the sample size for one-sided equivalence of sensitivities based upon McNemar’s test
    • Lu, Y. and Bean, J.A. (1995) On the sample size for one-sided equivalence of sensitivities based upon McNemar’s test. Statistics in Medicine 14:1831-9.
    • (1995) Statistics in Medicine , vol.14 , pp. 1831-1839
    • Lu, Y.1    Bean, J.A.2
  • 112
    • 0018103242 scopus 로고
    • Sample size requirements for evaluating a conservative therapy
    • Makuch, R.W. and Simon, R. (1978) Sample size requirements for evaluating a conservative therapy. Cancer Treatment Reports 62: 1037-40.
    • (1978) Cancer Treatment Reports , vol.62 , pp. 1037-1040
    • Makuch, R.W.1    Simon, R.2
  • 113
    • 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 37: 213-22.
    • (1981) Biometrics , vol.37 , pp. 213-222
    • Mandallaz, D.1    Mau, J.2
  • 114
    • 8344238457 scopus 로고    scopus 로고
    • Fisher’s exact and Barnard’s tests
    • S. Kotz, C. Reid and D.L. Banks, eds, New York: John Wiley and Sons, Inc
    • Martín, A.A. (1998) Fisher’s exact and Barnard’s tests. In S. Kotz, C. Reid and D.L. Banks, eds., Encyclopedia of Statistical Sciences, vol. 2. New York: John Wiley and Sons, Inc., 250-8.
    • (1998) Encyclopedia of Statistical Sciences , vol.2 , pp. 250-258
    • Martín, A.A.1
  • 115
    • 85152353739 scopus 로고
    • On Cox’s confidence distribution
    • R. Viertl, ed, New York: Plenum
    • Mau, J. (1987) On Cox’s confidence distribution. In R. Viertl, ed., Probability and Bayesian Statistics. New York: Plenum., 346-56.
    • (1987) Probability and Bayesian Statistics , pp. 346-356
    • Mau, J.1
  • 116
    • 0024241319 scopus 로고
    • A statistical assessment of clinical equivalence
    • Mau, J. (1988) A statistical assessment of clinical equivalence. Statistics in Medicine 7: 1267-77.
    • (1988) Statistics in Medicine , vol.7 , pp. 1267-1277
    • Mau, J.1
  • 117
    • 0042014070 scopus 로고
    • Algorithm AS161: Critical regions of an unconditional non-randomized test of homogeneity in 2 × 2 contingency tables
    • McDonald, L.L., Davis, B.M., Bauer, H.R. and Laby, B. (1981) Algorithm AS161: critical regions of an unconditional non-randomized test of homogeneity in 2 × 2 contingency tables. Applied Statistics 30: 182-9.
    • (1981) Applied Statistics , vol.30 , pp. 182-189
    • McDonald, L.L.1    Davis, B.M.2    Bauer, H.R.3    Laby, B.4
  • 118
    • 0000800267 scopus 로고
    • A nonrandomized unconditional test for comparing two proportions in a 2 × 2 contingency table
    • McDonald, L.L., Davis, B.M. and Milliken, G.A. (1977) A nonrandomized unconditional test for comparing two proportions in a 2 × 2 contingency table. Technometrics 19: 145-50.
    • (1977) Technometrics , vol.19 , pp. 145-150
    • McDonald, L.L.1    Davis, B.M.2    Milliken, G.A.3
  • 119
    • 0000596361 scopus 로고
    • Note on the sampling error of the difference between correlated proportions or percentages
    • McNemar, I. (1947) Note on the sampling error of the difference between correlated proportions or percentages. Psychometrika 12: 153-7.
    • (1947) Psychometrika , vol.12 , pp. 153-157
    • McNemar, I.1
  • 121
    • 0021496477 scopus 로고
    • Exact significance testing to establish treatment equivalence with ordered categorical data
    • Mehta, C.R., Patel, N.R. and Tsiatis, A.A. (1984) Exact significance testing to establish treatment equivalence with ordered categorical data. Biometrics 40: 819-25.
    • (1984) Biometrics , vol.40 , pp. 819-825
    • Mehta, C.R.1    Patel, N.R.2    Tsiatis, A.A.3
  • 122
    • 85015506475 scopus 로고    scopus 로고
    • Comment on “Bioequivalence trials, intersection-union tests and equivalence confidence sets
    • Meredith, M.P. and Heise, M.A. (1996) Comment on “Bioequivalence trials, intersection-union tests and equivalence confidence sets.” Statistical Science 11: 304-6.
    • (1996) Statistical Science , vol.11 , pp. 304-306
    • Meredith, M.P.1    Heise, M.A.2
  • 123
    • 0016206702 scopus 로고
    • Bioavailability - a problem in equivalence
    • Metzler, C.M. (1974) Bioavailability - a problem in equivalence. Biometrics 30: 309-17.
    • (1974) Biometrics , vol.30 , pp. 309-317
    • Metzler, C.M.1
  • 126
    • 0002829661 scopus 로고
    • A test for the significance of the difference between the two variances in a sample from a normal bivariate population
    • Morgan, W.A. (1939) A test for the significance of the difference between the two variances in a sample from a normal bivariate population. Biometrika 31: 13-9.
    • (1939) Biometrika , vol.31 , pp. 13-19
    • Morgan, W.A.1
  • 128
    • 0042121404 scopus 로고
    • Non-parametric methods
    • H. Walker and J. Lev, eds, New York: Holt, Rinehart and Winston
    • Moses, L.E. (1953) Non-parametric methods. In H. Walker and J. Lev, eds., Statistical Inference. New York: Holt, Rinehart and Winston, 426-50.
    • (1953) Statistical Inference , pp. 426-450
    • Moses, L.E.1
  • 129
    • 85152323869 scopus 로고
    • Size and power of the Anderson-Hauck test and the double t-test in equivalence problems
    • Copenhagen:European Users Group Internations Conference
    • Muller-Cohrs, J. (1988) Size and power of the Anderson-Hauck test and the double t-test in equivalence problems. In Proceedings of the SAS. Copenhagen:European Users Group Internations Conference., 30-8.
    • (1988) Proceedings of the SAS , pp. 30-38
    • Muller-Cohrs, J.1
  • 130
    • 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: 1225-30.
    • (1993) Biometrics , vol.49 , pp. 1225-1230
    • Munk, A.1
  • 131
    • 0030329266 scopus 로고    scopus 로고
    • Equivalence and interval testing for Lehmann’s alternative
    • Munk, A. (1996) Equivalence and interval testing for Lehmann’s alternative. Journal of the American Statistical Association 91: 1187-96.
    • (1996) Journal of the American Statistical Association , vol.91 , pp. 1187-1196
    • Munk, A.1
  • 132
    • 0031946427 scopus 로고    scopus 로고
    • Power and sample size for stratified prospective studies using the score method for testing relative risk
    • Nam, J. (1998) Power and sample size for stratified prospective studies using the score method for testing relative risk. Biometrics 54: 331-6.
    • (1998) Biometrics , vol.54 , pp. 331-336
    • Nam, J.1
  • 133
    • 33846211378 scopus 로고    scopus 로고
    • Non-inferiority of new procedure to standard procedure in stratified matched-pair design
    • Nam, J. (2006) Non-inferiority of new procedure to standard procedure in stratified matched-pair design. Biometrical Journal 48: 966-77.
    • (2006) Biometrical Journal , vol.48 , pp. 966-977
    • Nam, J.1
  • 134
    • 0037088328 scopus 로고    scopus 로고
    • Analysis of the ratio of marginal probabilities in a matched-pair setting
    • Nam, J. and Blackwelder, W.C. (2002) Analysis of the ratio of marginal probabilities in a matched-pair setting. Statistics in Medicine 21: 689-99.
    • (2002) Statistics in Medicine , vol.21 , pp. 689-699
    • Nam, J.1    Blackwelder, W.C.2
  • 135
    • 0040051172 scopus 로고
    • Contributions to the theory of testing statistical hypotheses I. Unbiased critical regions of type A and type A1
    • Neyman, J. and Pearson, E.S. (1936) Contributions to the theory of testing statistical hypotheses I. Unbiased critical regions of type A and type A1. Statistical Research Memoirs 1: 1-37.
    • (1936) Statistical Research Memoirs , vol.1 , pp. 1-37
    • Neyman, J.1    Pearson, E.S.2
  • 137
    • 0005429786 scopus 로고
    • The choice of statistical tests illustrated on their interpretation of data classified in a 2 × 2 table
    • Pearson, E.S. (1947) The choice of statistical tests illustrated on their interpretation of data classified in a 2 × 2 table. Biometrika 34: 139-67.
    • (1947) Biometrika , vol.34 , pp. 139-167
    • Pearson, E.S.1
  • 138
    • 0042824985 scopus 로고    scopus 로고
    • The emperor’s new tests
    • Perlman, M.D. and Wu, L. (1999) The emperor’s new tests. Statistical Science 14: 355-69.
    • (1999) Statistical Science , vol.14 , pp. 355-369
    • Perlman, M.D.1    Wu, L.2
  • 140
    • 0030762672 scopus 로고    scopus 로고
    • Randomised, double blind multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: Results of the HANE study
    • Philipp, T., Anlauf, M., Distler, A., Holzgreve, H., Michaelis, J. and Wellek, S. (1997) Randomised, double blind multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: Results of the HANE study. British Medical Journal 315:154-9.
    • (1997) British Medical Journal , vol.315 , pp. 154-159
    • Philipp, T.1    Anlauf, M.2    Distler, A.3    Holzgreve, H.4    Michaelis, J.5    Wellek, S.6
  • 141
    • 0002363710 scopus 로고
    • A note on normal correlation
    • Pitman, E.J.G. (1939) A note on normal correlation. Biometrika 31: 9-12.
    • (1939) Biometrika , vol.31 , pp. 9-12
    • Pitman, E.J.G.1
  • 142
  • 146
    • 0036153555 scopus 로고    scopus 로고
    • Promoter polymorphisms of the genes encoding tumor necrosis factor-α and interleukin-1β are associated with different subtypes of psoriasis characterized by early and late disease onset
    • Reich, K., Mossner, R., Konig, I.R., Westphal, G., Ziegler, A. and Neumann, C. (2002) Promoter polymorphisms of the genes encoding tumor necrosis factor-α and interleukin-1β are associated with different subtypes of psoriasis characterized by early and late disease onset. The Journal of Investigative Dermatology 118: 155-63.
    • (2002) The Journal of Investigative Dermatology , vol.118 , pp. 155-163
    • Reich, K.1    Mossner, R.2    Konig, I.R.3    Westphal, G.4    Ziegler, A.5    Neumann, C.6
  • 148
    • 0024500576 scopus 로고
    • How to establish equivalence between treatments: A one-sided clinical trial in paediatric oncology
    • Rodary, C., Com-Nougue, C. and Tournade, M.F. (1989) How to establish equivalence between treatments: A one-sided clinical trial in paediatric oncology. Statistics in Medicine 8: 593-8.
    • (1989) Statistics in Medicine , vol.8 , pp. 593-598
    • Rodary, C.1    Com-Nougue, C.2    Tournade, M.F.3
  • 149
    • 85052687450 scopus 로고
    • Bioavailability: Designs and analysis
    • D.A. Berry, ed, New York:Marcel Dekker Inc
    • Rodda, B.E. (1990) Bioavailability: Designs and analysis. In D.A. Berry, ed., Statistical Methodology in the Pharmaceutical Sciences. New York:Marcel Dekker Inc, 57-81.
    • (1990) Statistical Methodology in the Pharmaceutical Sciences , pp. 57-81
    • Rodda, B.E.1
  • 150
    • 0018976518 scopus 로고
    • Determining the probability of an important difference in bioavailability
    • Rodda, B.E. and Davis, R.L. (1980) Determining the probability of an important difference in bioavailability. Clinical Pharmacology and Therapeutics 28: 247-52.
    • (1980) Clinical Pharmacology and Therapeutics , vol.28 , pp. 247-252
    • Rodda, B.E.1    Davis, R.L.2
  • 151
    • 0029128443 scopus 로고
    • Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial probabilities
    • Roebruck, P. and Kühn, A. (1995) Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial probabilities. Statistics in Medicine 14: 1583-94.
    • (1995) Statistics in Medicine , vol.14 , pp. 1583-1594
    • Roebruck, P.1    Kühn, A.2
  • 152
    • 15244359938 scopus 로고    scopus 로고
    • Problems with existing procedures to calculate exact unconditional p-values for non-inferiority/superiority and confidence intervals for two binomials and how to resolve them
    • Röhmel, J. (2005) Problems with existing procedures to calculate exact unconditional p-values for non-inferiority/superiority and confidence intervals for two binomials and how to resolve them. Biometrical Journal 47:37-47.
    • (2005) Biometrical Journal , vol.47 , pp. 37-47
    • Röhmel, J.1
  • 153
    • 0039165517 scopus 로고    scopus 로고
    • Unconditional non-asymptotic onesided tests for independent binomial proportions when the interest lies in showing non-inferiority and/or superiority
    • Röhmel, J. and Mannsmann, U. (1999a) Unconditional non-asymptotic onesided tests for independent binomial proportions when the interest lies in showing non-inferiority and/or superiority. Biometrical Journal 41:149-70.
    • (1999) Biometrical Journal , vol.41 , pp. 149-170
    • Röhmel, J.1    Mannsmann, U.2
  • 154
    • 0012948667 scopus 로고    scopus 로고
    • Letter to the editor on “Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies” by S.F. Chan
    • Röhmel, J. and Mannsmann, U. (1999b) Letter to the editor on “Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies” by S.F. Chan. Statistics in Medicine 18: 1734-5.
    • (1999) Statistics in Medicine , vol.18 , pp. 1734-1735
    • Röhmel, J.1    Mannsmann, U.2
  • 155
    • 23744499740 scopus 로고    scopus 로고
    • Optimal testing of equivalence hypotheses
    • Romano, J.P. (2005) Optimal testing of equivalence hypotheses. Annals of Statistics 33: 1036-47.
    • (2005) Annals of Statistics , vol.33 , pp. 1036-1047
    • Romano, J.P.1
  • 156
    • 0000308754 scopus 로고
    • On a heuristic method of test construction and its use in multivariate analysis
    • Roy, S.N. (1953) On a heuristic method of test construction and its use in multivariate analysis. Annals of Mathematical Statistics 24: 220-38.
    • (1953) Annals of Mathematical Statistics , vol.24 , pp. 220-238
    • Roy, S.N.1
  • 157
    • 0031466983 scopus 로고    scopus 로고
    • From genotype to genes: Doubling the sample size
    • Sasieni, P.D. (1997) From genotype to genes: Doubling the sample size. Biometrics 53: 1253-61.
    • (1997) Biometrics , vol.53 , pp. 1253-1261
    • Sasieni, P.D.1
  • 158
    • 0001343578 scopus 로고
    • Contributions to the theory of rank order statistics - the two-sample case
    • Savage, I.R. (1956) Contributions to the theory of rank order statistics - the two-sample case. Annals of Mathematical Statistics 27: 590-615.
    • (1956) Annals of Mathematical Statistics , vol.27 , pp. 590-615
    • Savage, I.R.1
  • 159
    • 0025260401 scopus 로고
    • Comparison of the clinical and bacteriological efficacy of clarithromycin and erythromycin in the treatment of streptococcal pharyngitis
    • Scaglione, F. (1990) Comparison of the clinical and bacteriological efficacy of clarithromycin and erythromycin in the treatment of streptococcal pharyngitis. Current Medical Research and Opinion 12: 25-33.
    • (1990) Current Medical Research and Opinion , vol.12 , pp. 25-33
    • Scaglione, F.1
  • 160
    • 0029083127 scopus 로고
    • Assessment of individual and population bioequivalence us ing the probability that bioavailabilities are similar
    • Schall, R. (1995) Assessment of individual and population bioequivalence us ing the probability that bioavailabilities are similar. Biometrics 51: 615-26.
    • (1995) Biometrics , vol.51 , pp. 615-626
    • Schall, R.1
  • 161
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • Schall, R. and Luus, H.G. (1993) On population and individual bioequivalence. Statistics in Medicine 12: 1109-24.
    • (1993) Statistics in Medicine , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, H.G.2
  • 162
    • 0000549737 scopus 로고
    • The asymptotic properties of nonparametric tests comparing survival distributions
    • Schoenfeld, D. (1981) The asymptotic properties of nonparametric tests comparing survival distributions. Biometrika 68: 316-9.
    • (1981) Biometrika , vol.68 , pp. 316-319
    • Schoenfeld, D.1
  • 163
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing equivalence of average bioavailability
    • Schuirmann, D.J. (1987) A comparison of the two one-sided tests procedure and the power approach for assessing equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 15: 657-80.
    • (1987) Journal of Pharmacokinetics and Biopharmaceutics , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 164
    • 85015486170 scopus 로고    scopus 로고
    • Comment on “Bioequivalence trials, intersectionunion tests and equivalence confidence sets
    • Schuirmann, D.J. (1996) Comment on “Bioequivalence trials, intersectionunion tests and equivalence confidence sets.” Statistical Science 11: 312-3.
    • (1996) Statistical Science , vol.11 , pp. 312-313
    • Schuirmann, D.J.1
  • 167
    • 0019541686 scopus 로고
    • A Bayesian approach to bioequivalence for the 2 × 2 changeover design
    • Selwyn, M.R., Dempster, A.P. and Hall, N.R. (1981) A Bayesian approach to bioequivalence for the 2 × 2 changeover design. Biometrics 37: 11-21.
    • (1981) Biometrics , vol.37 , pp. 11-21
    • Selwyn, M.R.1    Dempster, A.P.2    Hall, N.R.3
  • 168
    • 0021702745 scopus 로고
    • On Bayesian methods for bioequivalence
    • Selwyn, M.R. and Hall, N.R. (1984) On Bayesian methods for bioequivalence. Biometrics 40: 1103-8.
    • (1984) Biometrics , vol.40 , pp. 1103-1108
    • Selwyn, M.R.1    Hall, N.R.2
  • 169
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • Sheiner, L.B. (1992) Bioequivalence revisited. Statistics in Medicine 11: 1777-88.
    • (1992) Statistics in Medicine , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1
  • 170
    • 0042167157 scopus 로고
    • Tables of the distribution of the Mann-Whitney-Wilcoxon U-statistic under Lehmann alternatives
    • Shorack, R. (1967) Tables of the distribution of the Mann-Whitney-Wilcoxon U-statistic under Lehmann alternatives. Technometrics 9: 666-77.
    • (1967) Technometrics , vol.9 , pp. 666-677
    • Shorack, R.1
  • 171
    • 0037472852 scopus 로고    scopus 로고
    • Exact unconditional tests for testing non-inferiority in matched-pairs design
    • Sidik, K. (2003) Exact unconditional tests for testing non-inferiority in matched-pairs design. Statistics in Medicine 22: 265-78.
    • (2003) Statistics in Medicine , vol.22 , pp. 265-278
    • Sidik, K.1
  • 172
    • 0018546041 scopus 로고
    • An improved sign test for experiments in which neutral responses are possible
    • Starks, T.H. (1979) An improved sign test for experiments in which neutral responses are possible. Technometrics 21: 525-30.
    • (1979) Technometrics , vol.21 , pp. 525-530
    • Starks, T.H.1
  • 173
    • 0020662337 scopus 로고
    • Statistical analysis of bioavailability studies: Parametric and nonparametric confidence intervals
    • Steinijans, V.W. and Diletti, E. (1983) Statistical analysis of bioavailability studies: Parametric and nonparametric confidence intervals. European Journal of Clinical Pharmacology 24: 127-36.
    • (1983) European Journal of Clinical Pharmacology , vol.24 , pp. 127-136
    • Steinijans, V.W.1    Diletti, E.2
  • 174
    • 0021924569 scopus 로고
    • Generalisation of distribution-free confidence intervals for bioavailability ratios
    • Steinijans, V.W. and Diletti, E. (1985) Generalisation of distribution-free confidence intervals for bioavailability ratios. European Journal of Clinical Pharmacology 28: 85-8.
    • (1985) European Journal of Clinical Pharmacology , vol.28 , pp. 85-88
    • Steinijans, V.W.1    Diletti, E.2
  • 175
    • 4344634865 scopus 로고
    • Estimation of blood-group gene frequencies
    • Stevens, W.L. (1938) Estimation of blood-group gene frequencies. Annals of Eugenics 8: 362-75.
    • (1938) Annals of Eugenics , vol.8 , pp. 362-375
    • Stevens, W.L.1
  • 178
    • 0032580373 scopus 로고    scopus 로고
    • Equivalence test and confidence interval for the difference in proportions for the paired-sample design
    • Tango, T. (1998) Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Statistics in Medicine 17:891-908.
    • (1998) Statistics in Medicine , vol.17 , pp. 891-908
    • Tango, T.1
  • 180
    • 0023373321 scopus 로고
    • On clinically relevant differences and shifted nullhypotheses
    • Victor, N. (1987) On clinically relevant differences and shifted nullhypotheses. Methods of Information in Medicine 26: 155-62.
    • (1987) Methods of Information in Medicine , vol.26 , pp. 155-162
    • Victor, N.1
  • 181
    • 21744458372 scopus 로고    scopus 로고
    • Optimal unbiased tests for equivalence in intrasubject variability
    • Wang, W. (1997) Optimal unbiased tests for equivalence in intrasubject variability. Journal of the American Statistical Association 92: 1163-70.
    • (1997) Journal of the American Statistical Association , vol.92 , pp. 1163-1170
    • Wang, W.1
  • 182
    • 0000576729 scopus 로고
    • The significance of the difference between means when the population variances are unequal
    • Welch, B.L. (1938) The significance of the difference between means when the population variances are unequal. Biometrika 29: 350-62.
    • (1938) Biometrika , vol.29 , pp. 350-362
    • Welch, B.L.1
  • 183
    • 0040248082 scopus 로고
    • Vorschläge zur Reformulierung der statistischen Definition von Bioäquivalenz
    • G. Giani and R. Repges, eds, Berlin:Springer-Verlag
    • Wellek, S. (1990) Vorschläge zur Reformulierung der statistischen Definition von Bioäquivalenz. In G. Giani and R. Repges, eds., Biometrie und Informatik - Neue Wege zur Erkenntnisgewinnung in der Medizin. Berlin:Springer-Verlag, 95-9.
    • (1990) Biometrie und Informatik - Neue Wege zur Erkenntnisgewinnung in der Medizin , pp. 95-99
    • Wellek, S.1
  • 184
    • 0040548905 scopus 로고
    • Zur Formulierung und optimalen Lösung des Bioäquivalenznachweis-Problems in der klassischen Theorie des Hypothesentestens
    • J. Vollmar, ed, Stuttgart: Gustav Fischer Verlag
    • Wellek, S. (1991) Zur Formulierung und optimalen Lösung des Bioäquivalenznachweis-Problems in der klassischen Theorie des Hypothesentestens. In J. Vollmar, ed., Bioäquivalenz sofort freisetzender Arzneiformen. Stuttgart: Gustav Fischer Verlag, 91-109.
    • (1991) Bioäquivalenz sofort freisetzender Arzneiformen , pp. 91-109
    • Wellek, S.1
  • 185
    • 84985644178 scopus 로고
    • Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence
    • Wellek, S. (1993a) Basing the analysis of comparative bioavailability trials on an individualized statistical definition of equivalence. Biometrical Journal 35: 47-55.
    • (1993) Biometrical Journal , vol.35 , pp. 47-55
    • Wellek, S.1
  • 186
    • 0027440319 scopus 로고
    • A log-rank test for equivalence of two survivor functions
    • Wellek, S. (1993b) A log-rank test for equivalence of two survivor functions. Biometrics 49: 877-81.
    • (1993) Biometrics , vol.49 , pp. 877-881
    • Wellek, S.1
  • 188
    • 0030519976 scopus 로고    scopus 로고
    • A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic
    • Wellek, S. (1996) A new approach to equivalence assessment in standard comparative bioavailability trials by means of the Mann-Whitney statistic. Biometrical Journal 38: 695-710.
    • (1996) Biometrical Journal , vol.38 , pp. 695-710
    • Wellek, S.1
  • 189
    • 0034551205 scopus 로고    scopus 로고
    • Bayesian construction of an improved parametric test for probability-based individual bioequivalence
    • Wellek, S. (2000a) Bayesian construction of an improved parametric test for probability-based individual bioequivalence. Biometrical Journal 42:1039-52.
    • (2000) Biometrical Journal , vol.42 , pp. 1039-1052
    • Wellek, S.1
  • 190
    • 0034735534 scopus 로고    scopus 로고
    • On a reasonable disaggregate criterion on population bioequivalence admitting of resampling-free testing procedures
    • Wellek, S. (2000b) On a reasonable disaggregate criterion on population bioequivalence admitting of resampling-free testing procedures. Statistics in Medicine 19: 2755-67.
    • (2000) Statistics in Medicine , vol.19 , pp. 2755-2767
    • Wellek, S.1
  • 191
    • 4444302308 scopus 로고    scopus 로고
    • Tests for establishing compatibility of an observed genotype distribution with Hardy-Weinberg equilibrium in the case of a biallelic locus
    • Wellek, S. (2004) Tests for establishing compatibility of an observed genotype distribution with Hardy-Weinberg equilibrium in the case of a biallelic locus. Biometrics 60: 694-703.
    • (2004) Biometrics , vol.60 , pp. 694-703
    • Wellek, S.1
  • 192
    • 15244359936 scopus 로고    scopus 로고
    • Statistical methods for the analysis of two-arm noninferiority trials with binary outcomes
    • Wellek, S. (2005) Statistical methods for the analysis of two-arm noninferiority trials with binary outcomes. Biometrical Journal 47: 48-61.
    • (2005) Biometrical Journal , vol.47 , pp. 48-61
    • Wellek, S.1
  • 193
    • 0025743944 scopus 로고
    • Elements of significance testing with equivalence problems
    • Wellek, S. and Michaelis, J. (1991) Elements of significance testing with equivalence problems. Methods of Information in Medicine 30: 194-8.
    • (1991) Methods of Information in Medicine , vol.30 , pp. 194-198
    • Wellek, S.1    Michaelis, J.2
  • 194
    • 85152853845 scopus 로고    scopus 로고
    • A confidence-limit-based approach to the assessment of Hardy-Weinberg equilibrium
    • 2008/9 - 2. Department of Biostatistics, CIMH Mannheim
    • Wellek, S., Ziegler, A. and Goddard, K.A.B. (2009) A confidence-limit-based approach to the assessment of Hardy-Weinberg equilibrium. In Technical Report, 2008/9 - 2. Department of Biostatistics, CIMH Mannheim.
    • (2009) Technical Report
    • Wellek, S.1    Ziegler, A.2    Goddard, K.A.B.3
  • 195
    • 0015379868 scopus 로고
    • Use of confidence intervals in analysis of comparative bioavailability trials
    • Westlake, W.J. (1972) Use of confidence intervals in analysis of comparative bioavailability trials. Journal of Pharmacological Sciences 61: 1340-1.
    • (1972) Journal of Pharmacological Sciences , vol.61 , pp. 1340-1341
    • Westlake, W.J.1
  • 196
    • 0017028729 scopus 로고
    • Symmetrical confidence intervals for bioequivalence trials
    • Westlake, W.J. (1976) Symmetrical confidence intervals for bioequivalence trials. Biometrics 32: 741-4.
    • (1976) Biometrics , vol.32 , pp. 741-744
    • Westlake, W.J.1
  • 197
    • 0018411703 scopus 로고
    • Statistical aspects of comparative bioavailability trials
    • Westlake, W.J. (1979) Statistical aspects of comparative bioavailability trials. Biometrics 35: 273-80.
    • (1979) Biometrics , vol.35 , pp. 273-280
    • Westlake, W.J.1
  • 198
    • 0001305791 scopus 로고
    • Comments on “Bioequivalence testing - A need to rethink
    • Westlake, W.J. (1981) Comments on “Bioequivalence testing - A need to rethink.” Biometrics 37: 591-3.
    • (1981) Biometrics , vol.37 , pp. 591-593
    • Westlake, W.J.1
  • 200
    • 0034097663 scopus 로고    scopus 로고
    • Design and analysis of three treatment equivalence trials
    • Wiens, B.L. and Iglewicz, B. (2000) Design and analysis of three treatment equivalence trials. Controlled Clinical Trials 21: 127-37.
    • (2000) Controlled Clinical Trials , vol.21 , pp. 127-137
    • Wiens, B.L.1    Iglewicz, B.2
  • 202
    • 0030059336 scopus 로고    scopus 로고
    • Recommendations concerning studies on therapeutic equivalence
    • Windeler, J. and Trampisch, H.J. (1996) Recommendations concerning studies on therapeutic equivalence. Drug Information Journal 30: 195-200.
    • (1996) Drug Information Journal , vol.30 , pp. 195-200
    • Windeler, J.1    Trampisch, H.J.2
  • 204
    • 18944370235 scopus 로고    scopus 로고
    • Rational inferences about departures from Hardy-Weinberg equilibrium. American
    • Wittke-Thompson, J.K., Pluzhnikov, A. and Cox, N.J. (2005) Rational inferences about departures from Hardy-Weinberg equilibrium. American Journal of Human Genetics 76: 967-86.
    • (2005) Journal of Human Genetics , vol.76 , pp. 967-986
    • Wittke-Thompson, J.K.1    Pluzhnikov, A.2    Cox, N.J.3
  • 206
    • 0014859080 scopus 로고
    • Controlled study of the clinical effectiveness of a new oxygen gel on plaque, oral debris and gingival inflammation
    • Zinner, D.D., Duany, L.F. and Chilton, N.W. (1970) Controlled study of the clinical effectiveness of a new oxygen gel on plaque, oral debris and gingival inflammation. Pharmacology and Therapeutics in Dentistry 1:7-15.
    • (1970) Pharmacology and Therapeutics in Dentistry , vol.1 , pp. 7-15
    • Zinner, D.D.1    Duany, L.F.2    Chilton, N.W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.