The Bootstrap in Bioequivalence Studies

REFERENCES

• Ahn , B.-J. , Yim , D.-S. ( 2009 ). Comparison of parametric and bootstrap method in bioequivalence test . Korean Journal of Physiology and Pharmacology 13 : 367 – 371 .
   PubMedGoogle Scholar
• Anderson , S. , Hauck , W. W. ( 1990 ). Consideration of individual bioequivalence . Journal of Pharmacokinetics and Biopharmacy 18 : 259 – 273 .
   PubMedGoogle Scholar
• Barnhart , H. X. , Kosinski , A. S. , Haber , M. J. ( 2007 ). Assessing individual agreement . Journal of Biopharmaceutical Statistics 17 : 697 – 719 .
   PubMed Web of Science ®Google Scholar
• Chen , Y.-I. , Huang , C.-S. ( 2009 ). Multiple testing for bioequivalence with pharmacokinetic data in 2 × 2 crossover designs . Statistics in Medicine 28 : 3567 – 3579 .
   PubMed Web of Science ®Google Scholar
• Committee for Proprietary Medicinal Products. ( 2001 ). Note for Guidance on the Investigation of Bioavailability and Bioequivalence . London : EMEA .
   Google Scholar
• Committee for Medicinal Products for Human Use. ( 2010 ). Guideline on the Investigation of Bioequivalence . London : EMEA .
   Google Scholar
• Efron , B. , Tibshirani , R. J. ( 1993 ). An Introduction to the Bootstrap . New York : Chapman & Hall .
   Google Scholar
• Ekbohm , G. , Melander , H. ( 1989 ). The subject-by-formulation interaction as a criterion of interchangeability of drugs . Biometrics 45 : 1249 – 1254 .
   Web of Science ®Google Scholar
• Food and Drug Administration. ( 1997 ). In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches. Guidance for Industry . Rockville , MD : Center for Drug Evaluation and Research, Food and Drug Administration .
   Google Scholar
• Food and Drug Administration. ( 1999 ). Average, Population and Individual Approaches to Establishing Bioequivalence . Rockville , MD : Center for Drug Evaluation and Research, Food and Drug Administration .
   Google Scholar
• Food and Drug Administration. ( 2000 ). Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations . Rockville , MD : Center for Drug Evaluation and Research, Food and Drug Administration .
   Google Scholar
• Food and Drug Administration. ( 2001 ). Guidance for Industry. Statistical Approaches to Establishing Bioequivalence . Rockville , MD : Center for Drug Evaluation and Research, Food and Drug Administration .
   Google Scholar
• Food and Drug Administration. ( 2003 ). Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations . Rockville , MD : Center for Drug Evaluation and Research, Food and Drug Administration .
   Google Scholar
• Hauck , W. W. , Anderson , S. ( 1992 ). Types of bioequivalence and related statistical considerations . International Journal of Clinical Pharmacology, Theraphy, and Toxicology 30 : 181 – 187 .
   PubMed Web of Science ®Google Scholar
• Hauschke , D. , Steinijans , V. , Pigeot , I. ( 2007 ). Bioequivalence Studies in Drug Development . Chichester : John Wiley & Sons .
   Google Scholar
• Health Canada. ( 2010 ). Draft Guidance Document. Conduct and Analysis of Comparative Bioavailability Studies. Ottawa .
   Google Scholar
• 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 .
   PubMedGoogle Scholar
• Hyslop , T. , Hsuan , F. , Holder , D. J. ( 2000 ). A small sample confidence approach to assess individual bioequivalence . Statistics in Medicine 19 : 2885 – 2897 .
   PubMed Web of Science ®Google Scholar
• Jaki , T. , Wolfsegger , M. J. , Ploner , M. ( 2009 ). Confidence intervals for ratios of AUCs in the case of serial sampling: A comparison of seven methods . Pharmaceutical Statistics 8 : 12 – 24 .
   PubMed Web of Science ®Google Scholar
• Jaki , T. , Wolfsegger , M. J. , Lawo , J.-P. ( 2010 ). Establishing bioequivalence in complete and incomplete data designs using AUCs . Journal of Biopharmaceutical Statistics 20 : 803 – 820 .
   PubMed Web of Science ®Google Scholar
• Jianping , W. , Zhang , K. , Hui , C. ( 2009 ). The bootstrap and Bayesian bootstrap method in assessing bioequivalence . Chaos, Solutions and Fractals 41 : 2246 – 2249 .
   Google Scholar
• Kytariolos , J. , Karalis , V. , Macheras , P. , Symillides , M. ( 2006 ). Novel scaled bioequivalence limits with levelling-off properties . Pharmaceutical Research 23 : 2657 – 2664 .
   PubMed Web of Science ®Google Scholar
• Patterson , S. ( 2001 ). A review of the development of biostatistical design and analysis techniques for assessing in vivo bioequivalence: Part two . Indian Journal of Pharmaceutical Sciences 63 : 169 – 186 .
   Google Scholar
• Schall , R. ( 1995 ). Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar . Biometrics 51 : 615 – 626 .
   PubMed Web of Science ®Google Scholar
• Schall , R. , Luus , H. G. ( 1993 ). On population and individual bioequivalence . Statistics in Medicine 12 : 1109 – 1124 .
   PubMed Web of Science ®Google Scholar
• Schall , R. , Williams , R. L. ( 1996 ). Towards a practical strategy for assessing individual bioequivalence . Journal of Pharmacokinetics and Biopharmaceutics 24 : 133 – 149 .
   PubMedGoogle Scholar
• Shao , J. , Kübler , J. , Pigeot , I. ( 2000a ). Consistency of the bootstrap procedure in individual bioequivalence . Biometrika 87 : 573 – 585 .
   Web of Science ®Google Scholar
• Shao , J. , Chow , S.-C. , Wang , B. ( 2000b ). The bootstrap procedure in individual bioequivalence . Statistics in Medicine 19 : 2741 – 2754 .
   PubMed Web of Science ®Google Scholar
• Shao , J. , Tu , D. (1995). The Jackknife and Bootstrap . New York : Springer.
   Google Scholar
• Stefanescu , C. , Mehrotra , D. V. ( 2007 ). A more powerful average bioequivalence analysis for the 2 × 2 crossover . Communications in Statistics—Simulation and Computation 37 : 1 – 13 .
   Google Scholar
• Takemoto , S. , Yamaoka , K. , Nishikawa , M. , Takakura , Y. ( 2006 ). Histogram analysis of pharmacokinetic parameters by bootstrap resampling from one-point sampling data in animal experiments . Drug Metabolism and Pharmacokinetics 21 : 458 – 464 .
   PubMed Web of Science ®Google Scholar
• Wolfsegger , M. J. ( 2007 ). Establishing bioequivalence in serial sacrifice designs . Journal of Pharmacokinetics and Pharmacodynamics 34 : 103 – 113 .
   PubMed Web of Science ®Google Scholar
• Zhang , K. , Ge , L. ( 2010 ). Bootstrap and MLS methods-based individual bioequivalence assessment . International Journal of Computational and Mathematical Sciences 4 : 314 – 316 .
   Google Scholar