메뉴 건너뛰기




Volumn 87, Issue 3, 2000, Pages 573-585

Consistency of the bootstrap procedure in individual bioequivalence

Author keywords

Bioequivalence; Bootstrap percentile; Consistency

Indexed keywords


EID: 0000010050     PISSN: 00063444     EISSN: None     Source Type: Journal    
DOI: 10.1093/biomet/87.3.573     Document Type: Article
Times cited : (16)

References (27)
  • 1
    • 0024988106 scopus 로고
    • Consideration of individual bioequivalence
    • ANDERSON, S. & HAUCK, W. W. (1990). Consideration of individual bioequivalence. J. Pharmacokin. Biopharm. 18, 259-73.
    • (1990) J. Pharmacokin. Biopharm. , vol.18 , pp. 259-273
    • Anderson, S.1    Hauck, W.W.2
  • 2
    • 0030949859 scopus 로고    scopus 로고
    • Individual bioequivalence - A regulatory update
    • CHEN, M.-L. (1997). Individual bioequivalence - a regulatory update. J. Biopharm. Statist. 7, 5-11.
    • (1997) J. Biopharm. Statist. , vol.7 , pp. 5-11
    • Chen, M.-L.1
  • 3
    • 0029965765 scopus 로고    scopus 로고
    • The assessment of individual and population bioequivalence
    • CHINCHILLI, V. M. (1996). The assessment of individual and population bioequivalence. J. Biopharm. Statist. 6, 1-14.
    • (1996) J. Biopharm. Statist. , vol.6 , pp. 1-14
    • Chinchilli, V.M.1
  • 4
    • 0029151903 scopus 로고
    • Current issues in bioequivalence trials
    • CHOW, S. C. & LIU, J. P. (1995). Current issues in bioequivalence trials. Drug Inf. J. 29, 795-804.
    • (1995) Drug Inf. J. , vol.29 , pp. 795-804
    • Chow, S.C.1    Liu, J.P.2
  • 6
    • 0024947084 scopus 로고
    • The subject-by-formulation interaction as a criterion of interchangeability of drugs
    • EKBOHM, G. & MELANDER, H. (1989). The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics 45, 1249-54.
    • (1989) Biometrics , vol.45 , pp. 1249-1254
    • Ekbohm, G.1    Melander, H.2
  • 7
    • 0028106933 scopus 로고
    • A method for the evaluation of individual bioequivalence
    • ENDRENYI, L. (1994). A method for the evaluation of individual bioequivalence. Int. J. Clin. Pharmacol. Ther. 32, 497-508.
    • (1994) Int. J. Clin. Pharmacol. Ther. , vol.32 , pp. 497-508
    • Endrenyi, L.1
  • 8
    • 0028291201 scopus 로고
    • Extension to the use of tolerance intervals for the assessment of individual bioequivalence
    • ESINHART, J. D. & CHINCHILLI, V. M. (1994). Extension to the use of tolerance intervals for the assessment of individual bioequivalence. J. Biopharm. Statist. 4, 39-52.
    • (1994) J. Biopharm. Statist. , vol.4 , pp. 39-52
    • Esinhart, J.D.1    Chinchilli, V.M.2
  • 9
    • 0004069407 scopus 로고    scopus 로고
    • Draft Guidance for Industry. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration
    • FOOD AND DRUG ADMINISTRATION (1997). In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches, Draft Guidance for Industry. Rockville, MD: Center for Drug Evaluation and Research, Food and Drug Administration.
    • (1997) In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches
  • 10
    • 0026597801 scopus 로고
    • Types of bioequivalence and related statistical considerations
    • HAUCK, W. W. & ANDERSON, S. (1992). Types of bioequivalence and related statistical considerations. Int. J. Clin. Pharmacol. Ther. Toxicol. 30, 181-7.
    • (1992) Int. J. Clin. Pharmacol. Ther. Toxicol. , vol.30 , pp. 181-187
    • Hauck, W.W.1    Anderson, S.2
  • 11
    • 0028676114 scopus 로고
    • Measuring switchability and prescribability: When is average bioequivalence sufficient?
    • HAUCK, W. W. & ANDERSON, S. (1994). Measuring switchability and prescribability: when is average bioequivalence sufficient? J. Pharmacokin. Biopharm. 22, 551-64.
    • (1994) J. Pharmacokin. Biopharm. , vol.22 , pp. 551-564
    • Hauck, W.W.1    Anderson, S.2
  • 12
    • 0033555874 scopus 로고    scopus 로고
    • Sample size determination for proving equivalence based on the ratio of two means for normally distributed data
    • HAUSCHKE, D., KIESER, M., DILETTI, E. & BURKE, M. (1999). Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Statist. Med. 18, 93-105.
    • (1999) Statist. Med. , vol.18 , pp. 93-105
    • Hauschke, D.1    Kieser, M.2    Diletti, E.3    Burke, M.4
  • 13
    • 0034735555 scopus 로고    scopus 로고
    • The U.S. draft guidance regarding population and individual bioequivalence approaches: Comments by research-based pharmaceutical company
    • To appear
    • HAUSCHKE, D. & STEINIJANS, V. W. (2000). The U.S. draft guidance regarding population and individual bioequivalence approaches: comments by research-based pharmaceutical company. Statist. Med. 19. To appear.
    • (2000) Statist. Med. , vol.19
    • Hauschke, D.1    Steinijans, V.W.2
  • 14
    • 0001474373 scopus 로고
    • Moment-based criteria for determining bioequivalence
    • HOLDER, D. J. & 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
  • 15
    • 0000590222 scopus 로고    scopus 로고
    • The validity of the test of individual equivalence ratios
    • HWANG, J. T. G. & WANG, W. (1997). The validity of the test of individual equivalence ratios. Biometrika 84, 893-900.
    • (1997) Biometrika , vol.84 , pp. 893-900
    • Hwang, J.T.G.1    Wang, W.2
  • 16
    • 0031396991 scopus 로고    scopus 로고
    • A parametric confidence interval for a moment-based scaled criterion for individual bioequivalence
    • KIMANANI, E. K. & POTVIN, D. (1997). A parametric confidence interval for a moment-based scaled criterion for individual bioequivalence. J. Pharmacokin. Biopharm. 25, 595-614.
    • (1997) J. Pharmacokin. Biopharm. , vol.25 , pp. 595-614
    • Kimanani, E.K.1    Potvin, D.2
  • 17
    • 0030771117 scopus 로고    scopus 로고
    • Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics
    • PATNAIK, R. N., LESKO, L. J., CHEN, M. L. & WILLIAMS, R. L. (1997). Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. Clin. Pharmacokinet. 33, 1-6.
    • (1997) Clin. Pharmacokinet. , vol.33 , pp. 1-6
    • Patnaik, R.N.1    Lesko, L.J.2    Chen, M.L.3    Williams, R.L.4
  • 18
    • 0029083127 scopus 로고
    • Assessment of individual and population bioequivalence using the probability that bioavail-abilities are similar
    • SCHALL, R. (1995). Assessment of individual and population bioequivalence using the probability that bioavail-abilities are similar. Biometrics 51, 615-26.
    • (1995) Biometrics , vol.51 , pp. 615-626
    • Schall, R.1
  • 19
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • SCHALL, R. & LUUS, H. G. (1993). On population and individual bioequivalence. Statist. Med. 12, 1109-24.
    • (1993) Statist. Med. , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, H.G.2
  • 20
    • 0030011261 scopus 로고    scopus 로고
    • Towards a practical strategy for assessing individual bioequivalence
    • SCHALL, R. & WILLIAMS, R. L. (1996). Towards a practical strategy for assessing individual bioequivalence. J. Pharmacokin. Biopharm. 24, 133-49.
    • (1996) J. Pharmacokin. Biopharm. , vol.24 , pp. 133-149
    • Schall, R.1    Williams, R.L.2
  • 22
    • 0042304469 scopus 로고
    • Bootstrap sample size in nonregular cases
    • SHAO, J. (1994). Bootstrap sample size in nonregular cases. Proc. Am. Math. Soc. 122, 1251-62.
    • (1994) Proc. Am. Math. Soc. , vol.122 , pp. 1251-1262
    • Shao, J.1
  • 23
    • 0032286261 scopus 로고    scopus 로고
    • Bootstrapping sample quantiles based on complex survey data under hot deck imputation
    • SHAO, J. & CHEN, Y. (1998). Bootstrapping sample quantiles based on complex survey data under hot deck imputation. Statist. Sinica 8, 1071-85.
    • (1998) Statist. Sinica , vol.8 , pp. 1071-1085
    • Shao, J.1    Chen, Y.2
  • 24
    • 0034735584 scopus 로고    scopus 로고
    • The bootstrap procedure in individual bioequivalence
    • To appear
    • SHAO, J., CHOW, S.-C. & WANG, B. (2000). The bootstrap procedure in individual bioequivalence. Statist. Med. 19. To appear.
    • (2000) Statist. Med. , vol.19
    • Shao, J.1    Chow, S.-C.2    Wang, B.3
  • 26
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • SHEINER, L. B. (1992). Bioequivalence revisited. Statist. Med. 11, 1777-88.
    • (1992) Statist. Med. , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1
  • 27
    • 0031795947 scopus 로고    scopus 로고
    • The Phenytoin trial is a case study of 'individual' bioequivalence
    • SHUMAKER, R. C. & METZLER, C. M. (1998). The Phenytoin trial is a case study of 'individual' bioequivalence. Drug. Inf. J. 32, 1063-72.
    • (1998) Drug. Inf. J. , vol.32 , pp. 1063-1072
    • Shumaker, R.C.1    Metzler, C.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.