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Original Articles

Use of Bayesian Methods for Multivariate Bioequivalence Measures

, &
Pages 42-66 | Received 05 Oct 2007, Accepted 01 Apr 2008, Published online: 07 Jan 2009

REFERENCES

  • Aitkin , M. ( 1991 ). Posterior Bayes factor (with discussion) . Journal of the Royal Statistical Society, B 53 : 111 – 142 .
  • Anderson , S. , Hauck , W. ( 1983 ). A new procedure for testing equivalence in comparative bioavailability and other clinical trials . Communications in Statistics—Theory and Methods 12 : 2663 – 2692 .
  • ANVISA ( 2002 ). Bioavailability/Bioequivalence Good Practices Manual/Agěncia Nacional de Vigilǎncia Sanitária; ANVISA: Brasília, DF. (http://www.anvisa.gov.br/eng/bio/manual/volume1.zip) .
  • Berger , R. L. , Hsu , J. C. ( 1996 ). Bioequivalence trials, intersection union tests and equivalence confidence sets (with discussion) . Statistical Science 11 : 283 – 319 .
  • Birkett , D. ( 2003 ). Generics—equal or not? Australian Prescriber 26 ( 4 ): 85 – 87 .
  • Burnham , K. P. , Anderson , D. R. ( 2002 ). Model Selection and Multi-Model Inference: A Practical Information—Theoretic Approach , 2nd ed. . New York : Springer .
  • Chinchilli , V. M. , Elswick , R. K. ( 1997 ). The multivariate assessment of bioequivalence . Journal of Biopharmaceutical Statistics 7 ( 1 ): 113 – 123 .
  • Chow , S. C. , Shao , J. , Wang , H. ( 2003 ). In vitro bioequivalence testing . Statistics in Medicine 22 : 55 – 68 .
  • Dangelo , G. , Potvin , D. , Turgeon , J. ( 2001 ). Carry-over effects in bioequivalence studies . Journal of Biopharmaceutical Statistics 11 ( 1–2 ): 35 – 43 .
  • Endremyi , L. , Fritsch , S. , Yan , W. ( 1991 ). (C max)/AUC is a clearance measure that (C max) for absorption rates in investigations of bioequivalence . Int. J. Clin. Pharmacol. Ther. Toxicol. 29 ( 10 ): 394 – 399 .
  • Escobar , M. D. , West , M. ( 1995 ). Bayesian density estimation and inference using mixtures . Journal of the American Statistical Association 90 : 577 – 580 .
  • FDA ( 1998 ). Guidance for Industry—E9 Statistical Principles for Clinical Trials; U. S. Department of Health and Human Services, FDA, Center of Drug Evaluation and Research (CDER): Rockwille, Maryland. (http://69.20.19.211/cder/guidance/ICH_E9-fnl.PDF).
  • FDA ( 2002 ). Bioavailability and Bioequivalence studies for orally administered drug products – general considerations; U. S. Department of Health and Human Services, FDA, Center of Drug Evaluation and Research (CDER): Rockwille, Maryland. (http://www.fda.gov/cder/guidance/4964dft.pdf) .
  • Gelfand , A. E. , Smith , A. F. M. ( 1990 ). Sampling-based approaches to calculating marginal densities . Journal of the American Statistical Association 85 ( 410 ): 398 – 409 .
  • Gelfand , A. E. , Hills , S. E. , Racine-Poon , A. , Smith , A. F. M. ( 1990 ). Illustration of Bayesian inference in normal data models using Gibbs sampling . Journal of the American Statistical Association 85 ( 412 ): 972 – 985 .
  • Gelfand , A. E. , Dey , D. K. , Chang , H. ( 1992 ). Model determination using predictive distributions with implementation sampling-based method (with discussion) . In: Bernardo , J. M. , Berger , J. O. , Dawid , A. P. , Smith , A. F. P. , eds. Bayesian Statistics 4 . New York : Oxford University Press , pp. 147 – 167 .
  • Gelman , A. ( 2006 ). Prior distributions for variance parameters in hierarchical models (comment on article by Browne and Draper) . Bayesian Analysis 1 ( 3 ): 515 – 534 .
  • Ghosh , P. , Khattree , R. ( 2003 ). Bayesian approach to average bioequivalence using Baye' factor . Journal of Biopharmaceutical Statistics 13 ( 4 ): 719 – 734 .
  • Ghosh , P. , Rosner , G. ( 2007 ). A semiparametric Bayesian approach to average bioequivalence . Statistics in Medicine 26 : 1224 – 1236 .
  • Ghosh , P. , Gönen , M. ( 2008 ). Bayesian modelling of multivariate average bioequivalence . Statistics in Medicine 27 ( 13 ): 2402 – 2419 .
  • Hsu , H. C. , Lu , H. L. , Chan , K. K. H. ( 1995 ). A novel multivariate approach for estimating the degree of similarity in bioequivailability between the pharmaceutical products . Journal of Biopharmaceutical Statistics 84 : 768 – 772 .
  • MacEachern , S. N. ( 1994 ). Estimating normal means with a conjugate style Dirichlet process prior . Communications in Statistics—Simulations and Computation 23 : 727 – 741 .
  • MacEachern , S. N. , Müeller , P. ( 1998 ). Estimating mixtures of Dirichlet process models . Journal of Computational and Graphical Studies 7 : 223 – 338 .
  • Mandallaz , D. , Mau , J. (1981). Comparison of different methods for decision-making in bioequivalence assessment. Biometrics 37:213–222.
  • Munk , A. , Pflüger , R. ( 1999 ). 1-alpha equivalent confidence rules for convex alternatives are alpha/2—level tests—with applications to the multivariate assessment of bioequivalence . Journal of the American Statistical Association 94 ( 448 ): 1311 – 1319 .
  • Racine , A. , Grieve , A. P. , Flühler , H. , Smith , A. F. M. ( 1986 ). Bayesian methods in practice: Experiences in the pharmaceutical industry (with discussion) . Applied Statistics 35 : 93 – 150 .
  • Racine-Poon , A. , Grieve , A. P. , Flühler , H. , Smith , A. F. M. ( 1987 ). A two-stage procedure for bioequivalence studies . Biometrics 43 : 847 – 856 .
  • Raftery , A. E. ( 1996 ). Hypothesis testing and model selection . In: Gilks , W. R. , Richardson , S. , Spiegelhalter , D. J. , eds. Markov Chain Monte Carlo in Practice . London : Chapman & Hall , pp. 163 – 187 .
  • Schwarz , G. ( 1978 ). Estimation the dimension of a model . Annals of Statistics 6 : 461 – 466 .
  • Selwyn , M. R. , Hall , N. R. ( 1984 ). On Bayesian methods for bioequivalence . Biometrics 40 : 1103 – 1108 .
  • Selwyn , M. R. , Dempster , A. P. , Hall , N. R. ( 1981 ). A Bayesian approach to bioequivalence for the 2 × 2 changeover design . Biometrics 37 : 11 – 21 .
  • Shao , J. , Chow , S. , Wang , B. ( 2000 ). The bootstrap procedure in individual bioequivalence . Statistics in Medicine 19 : 2741 – 2754 .
  • Spiegelhalter , D. J. , Myles , J. P. , Jones , D. R. , Abrams , K. R. ( 2000 ). Bayesian methods in health technology assessment: a review . Health Technology Assessment 4 ( 38 ): 1 – 30 .
  • Spiegelhalter , D. J. , Best , N. G. , Carlin , B. P. , Van der Linde , A. ( 2002 ). Bayesian measures of model complexity and fit (with discussion) . Journal of the Royal Statistical Society, B 64 : 583 – 639 .
  • Spiegelhalter , D. J. , Thomas , A. , Best , N. G. , Lunn , D. ( 2003 ). WinBUGS version 1.4 user manual. MRC Biostatistics Unit, Institute of Public Health and Department of Epidemiology & Public Health, Imperial College School of Medicine. (http://www.mrc-bsu.com.ac.uk/bugs)

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