메뉴 건너뛰기




Volumn 20, Issue 4, 2010, Pages 803-820

Establishing bioequivalence in complete and incomplete data designs using AUCs

Author keywords

AUC; Batch design; Bioequivalence; Complete data design; Serial sampling design; Sparse sampling

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONFIDENCE INTERVAL; DRUG EXPOSURE; MATHEMATICAL MODEL; NONHUMAN; PERFORMANCE MEASUREMENT SYSTEM; PRIORITY JOURNAL; PROCESS DESIGN; SAMPLE SIZE; SIMULATION;

EID: 77952926181     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543401003618835     Document Type: Article
Times cited : (10)

References (29)
  • 1
    • 0023761465 scopus 로고
    • Testing for the equality of area under the curves when using destructive measurement techniques
    • Bailer, A. J. (1988). Testing for the equality of area under the curves when using destructive measurement techniques. Journal of Pharmacokinetics and Biopharmaceutics 16:303-309.
    • (1988) Journal of Pharmacokinetics and Biopharmaceutics , vol.16 , pp. 303-309
    • Bailer, A.J.1
  • 2
    • 0029782530 scopus 로고    scopus 로고
    • Randomization tests for assessing the equality of area under curves for studies using destructive sampling
    • Bailer, A. J., Ruberg, S. J. (1996). Randomization tests for assessing the equality of area under curves for studies using destructive sampling. Journal of applied Toxicology 16:391-395.
    • (1996) Journal of Applied Toxicology , vol.16 , pp. 391-395
    • Bailer, A.J.1    Ruberg, S.J.2
  • 3
    • 0003922013 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research. U.S. Department of Health and Human Services Food and Drug Administration. Available at: last accessed 2009-04-24
    • Center for Drug Evaluation and Research (2001). Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. U.S. Department of Health and Human Services Food and Drug Administration. Available at: http://www.fda.gov/ Cder/guidance/3616fnl.pdf, last accessed 2009-04-24.
    • (2001) Guidance for Industry. Statistical Approaches to Establishing Bioequivalence
  • 4
    • 0003484780 scopus 로고    scopus 로고
    • Cambridge Series in Statistical and Probabilistic Mathematics. Cambridge: Cambridge University Press
    • Davison, A. C., Hinkley, D. V. (1997). Bootstrap Methods and Their Applications. Cambridge Series in Statistical and Probabilistic Mathematics. Cambridge: Cambridge University Press.
    • (1997) Bootstrap Methods and Their Applications
    • Davison, A.C.1    Hinkley, D.V.2
  • 5
    • 84988052077 scopus 로고
    • Nonparametric standard errors and confidence intervals (with discussion)
    • Efron, B. (1981). Nonparametric standard errors and confidence intervals (with discussion). Canadian Journal of Statistics 9:139-172.
    • (1981) Canadian Journal of Statistics , vol.9 , pp. 139-172
    • Efron, B.1
  • 8
    • 0031713841 scopus 로고    scopus 로고
    • Estimation of confidence intervals for area under the curve from destructively obtained pharmacokinetic data
    • Gagnon, R. C., Peterson, J. J. (1998). Estimation of confidence intervals for area under the curve from destructively obtained pharmacokinetic data. Journal of Pharmacokinetics and Biopharmaceutics 26:87-102.
    • (1998) Journal of Pharmacokinetics and Biopharmaceutics , vol.26 , pp. 87-102
    • Gagnon, R.C.1    Peterson, J.J.2
  • 11
    • 0030423085 scopus 로고    scopus 로고
    • A note on testing areas under the curve when using destructive measurement techniques
    • Heinzl, H. (1996). A note on testing areas under the curve when using destructive measurement techniques. Journal of Pharmacokinetics and Biopharmaceutics 24:651-655.
    • (1996) Journal of Pharmacokinetics and Biopharmaceutics , vol.24 , pp. 651-655
    • Heinzl, H.1
  • 12
    • 0032856847 scopus 로고    scopus 로고
    • A method for estimating and testing area under the curve in serial sacrifice, batch, and complete data designs
    • Holder, D. J., Hsuan, F., Dixit, R., Soper, K. (1999). A method for estimating and testing area under the curve in serial sacrifice, batch, and complete data designs. Journal of Biopharmaceutical Statistics 9:451-464.
    • (1999) Journal of Biopharmaceutical Statistics , vol.9 , pp. 451-464
    • Holder, D.J.1    Hsuan, F.2    Dixit, R.3    Soper, K.4
  • 13
    • 4644250843 scopus 로고    scopus 로고
    • Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects
    • Hu, C., Moore, K. H. P., Kim, Y. H., Sale, M. E. (2004). Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects. Journal of Pharmacokinetics and Pharmacodynamics 31:321-339.
    • (2004) Journal of Pharmacokinetics and Pharmacodynamics , vol.31 , pp. 321-339
    • Hu, C.1    Moore, K.H.P.2    Kim, Y.H.3    Sale, M.E.4
  • 14
    • 77749311489 scopus 로고    scopus 로고
    • A theoretical framework for estimation of AUCs in complete and incomplete sampling designs
    • Jaki, T., Wolfsegger, M. J. (2009a). A theoretical framework for estimation of AUCs in complete and incomplete sampling designs. Statistics in Biopharmaceutical Research 1:176-184.
    • (2009) Statistics in Biopharmaceutical Research , vol.1 , pp. 176-184
    • Jaki, T.1    Wolfsegger, M.J.2
  • 16
    • 65649153633 scopus 로고    scopus 로고
    • Confidence intervals for ratios of AUC's in the case of serial sampling: A comparison of seven methods
    • Jaki, T., Wolfsegger, M. J., Ploner, M. (2009). Confidence intervals for ratios of AUC's in the case of serial sampling: A comparison of seven methods. Pharmaceutical Statistics 8:12-24.
    • (2009) Pharmaceutical Statistics , vol.8 , pp. 12-24
    • Jaki, T.1    Wolfsegger, M.J.2    Ploner, M.3
  • 17
    • 0028859126 scopus 로고
    • Applying Bailer's method for AUC confidence intervals to sparse sampling
    • Nedelman, J. R., Gibiansky, E., Lau, D. T. W. (1995). Applying Bailer's method for AUC confidence intervals to sparse sampling. Pharmaceutical Research 12:124-128.
    • (1995) Pharmaceutical Research , vol.12 , pp. 124-128
    • Nedelman, J.R.1    Gibiansky, E.2    Lau, D.T.W.3
  • 18
    • 0031813999 scopus 로고    scopus 로고
    • An extension of Satterthawaite's approximation applied to pharmacokinetics
    • Nedelman, J. R., Jia, X. (1998). An extension of Satterthawaite's approximation applied to pharmacokinetics. Journal of Biopharmaceutical Statistics 8: 317-328.
    • (1998) Journal of Biopharmaceutical Statistics , vol.8 , pp. 317-328
    • Nedelman, J.R.1    Jia, X.2
  • 19
    • 35349016777 scopus 로고    scopus 로고
    • The use of toxicokinetic data in preclinical safety assessment: A toxicologic pathologist perspective
    • Ploemen, J.-P., Kramer, H., Krajnc, E. I., Martin, I. (2007). The use of toxicokinetic data in preclinical safety assessment: a toxicologic pathologist perspective. Toxicologic Pathology 35:834-837.
    • (2007) Toxicologic Pathology , vol.35 , pp. 834-837
    • Ploemen, J.-P.1    Kramer, H.2    Krajnc, E.I.3    Martin, I.4
  • 21
    • 35748932852 scopus 로고    scopus 로고
    • R Development Core Team. Vienna, Austria: R Foundation for Statistical Computing
    • R Development Core Team (2007). R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing.
    • (2007) R: A Language and Environment for Statistical Computing
  • 23
    • 84872636119 scopus 로고
    • An approximate distribution of estimates of variance components
    • Satterthwaite, F. E. (1946). An approximate distribution of estimates of variance components. Biometrics Bulletin 2:110-114.
    • (1946) Biometrics Bulletin , vol.2 , pp. 110-114
    • Satterthwaite, F.E.1
  • 24
    • 28844435154 scopus 로고    scopus 로고
    • The Jackknife applied to incomplete blood sampling models
    • Singer, J., Berger, M. (2003). The Jackknife applied to incomplete blood sampling models. Pharmaceutical Statistics 2:161-166.
    • (2003) Pharmaceutical Statistics , vol.2 , pp. 161-166
    • Singer, J.1    Berger, M.2
  • 25
    • 0023911929 scopus 로고
    • The effect of azone on ocular levobunolol absorption: Calculating the area under the curve and its standard error using tissue sampling compartments
    • Tang-Liu, D. D.-S., Burke, P. J. (1988). The effect of azone on ocular levobunolol absorption: calculating the area under the curve and its standard error using tissue sampling compartments. Pharmaceutical Research 5:238-241.
    • (1988) Pharmaceutical Research , vol.5 , pp. 238-241
    • Tang-Liu, D.D.-S.1    Burke, P.J.2
  • 28
    • 77749323223 scopus 로고    scopus 로고
    • Assessing systematic drug exposure in repeated dose toxicity studies in the case of complete and incomplete sampling
    • Wolfsegger, M. J., Jaki, T. (2009). Assessing systematic drug exposure in repeated dose toxicity studies in the case of complete and incomplete sampling. Biometrical Journal 51:1017-1026.
    • (2009) Biometrical Journal , vol.51 , pp. 1017-1026
    • Wolfsegger, M.J.1    Jaki, T.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.