180
Views
8
CrossRef citations to date
0
Altmetric
Original Articles

Establishing Bioequivalence in Complete and Incomplete Data Designs Using AUCs

, &
Pages 803-820 | Received 29 Sep 2008, Accepted 27 Apr 2009, Published online: 19 May 2010

REFERENCES

  • 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 .
  • 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 .
  • 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 .
  • Davison , A. C. , Hinkley , D. V. ( 1997 ). Bootstrap Methods and Their Applications . Cambridge Series in Statistical and Probabilistic Mathematics. Cambridge : Cambridge University Press .
  • Efron , B. ( 1981 ). Nonparametric standard errors and confidence intervals (with discussion) . Canadian Journal of Statistics 9 : 139 – 172 .
  • Efron , B. , Tibshirani , R. J. ( 1993 ). An Introduction to the Bootstrap . London : Chapman and Hall .
  • Fieller , E. C. ( 1954 ). Some problems in interval estimation . Journal of the Royal Statistical Society Series B (Methodological) 16 : 175 – 185 .
  • 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 .
  • Gibaldi , M. , Perrier , D. ( 1982 ). Pharmacokinetics . New York : Marcel Dekker .
  • Hall , P. ( 1992 ). The Bootstrap and Edgeworth Expansion . New York : Springer .
  • Heinzl , H. ( 1996 ). A note on testing areas under the curve when using destructive measurement techniques . Journal of Pharmacokinetics and Biopharmaceutics 24 : 651 – 655 .
  • 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.
  • 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 .
  • 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 .
  • Jaki , T. , Wolfsegger , M. J. ( 2010 ). PK: Basic Non-Compartmental Pharmacokinetics . R package version 1.2-2. Available at: http://www.r-project.org/
  • 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 .
  • 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 .
  • Nedelman , J. R. , Jia , X. ( 1998 ). An extension of Satterthawaite's approximation applied to pharmacokinetics . Journal of Biopharmaceutical Statistics 8 : 317 – 328 .
  • 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 .
  • Ploner , M. ( 2002 ). Bootstrap Confidence Intervals, An Overview and Comparisons by Means of Selected Applications . Ph.D. thesis, University of Vienna, Vienna, Austria .
  • R Development Core Team ( 2007 ). R: A Language and Environment for Statistical Computing . Vienna , Austria : R Foundation for Statistical Computing .
  • Resnick , S. I. ( 1999 ). A Probability Path . Boston : Birkhäuser .
  • Satterthwaite , F. E. ( 1946 ). An approximate distribution of estimates of variance components . Biometrics Bulletin 2 : 110 – 114 .
  • Singer , J. , Berger , M. ( 2003 ). The Jackknife applied to incomplete blood sampling models . Pharmaceutical Statistics 2 : 161 – 166 .
  • 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 .
  • Wolfsegger , M. J. ( 2007 ). Establishing bioequivalence in serial sacrifice designs . Journal of Pharmacokinetics and Pharmacodynamics 34 : 103 – 113 .
  • Wolfsegger , M. J. , Jaki , T. ( 2005 ). Estimation of AUC from 0 to infinity in serial sacrifice designs . Journal of Pharmacokinetics and Pharmacodynamics 32 : 757 – 766 .
  • 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 .
  • Yeh , C. ( 1990 ). Estimation and significant tests of area under the curve derived from incomplete blood sampling . American Statistical Association Proceedings of the Biopharmaceutical Section , pp. 74 – 81 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.