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On equivalence and bioequivalence testing

  • Autores: Jordi Ocaña i Rebull Árbol académico, M. Pilar Sánchez O., Alex Sánchez Pla Árbol académico, Josep Lluís Carrasco Pla
  • Localización: Sort: Statistics and Operations Research Transactions, ISSN 1696-2281, Vol. 32, Nº. 2, 2008, págs. 151-176
  • Idioma: inglés
  • Enlaces
  • Resumen

    • Equivalence testing is the natural approach to many statistical problems. First, its main application, bioequivalence testing, is reviewed. The basic concepts of bioequivalence testing (2×2 crossover designs, TOST, interval inclusion principle, etc.) and its problems (TOST biased character, the carryover problem, etc.) are considered. Next, equivalence testing is discussed more generally. Some applications and methods are reviewed and the relation of equivalence testing and distance-based inference is highlighted. A new distance-based method to determine whether two gene lists are equivalent in terms of their annotations in the Gene Ontology illustrates these ideas. We end with a general discussion and some suggestions for future research.

  • Referencias bibliográficas
    • Al-Mohizea A. M., Kadi, A. A., Al-Bekairi, A. M., Al-Balla, S. A., Al-Yamani, M. J, Al-Khamis, K. I, Niazy, E. M., El-Sayed, Y. M. (2007)....
    • Anderson, S. and Hauck, W. W. (1983). A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Communications...
    • Anderson, S. and Hauck, W. W. (1990). Consideration of individual bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics, 18, 259-273.
    • Barker, L., Luman, E. T., Mc Cauley, M. M. and Chu, S. Y. (2002). Assessing equivalence: an alternative to the use of difference tests for...
    • Barker, L., Rolka, H., Rolka, D. and Brown, C. (2001). Equivalence testing for binomial random variables: Which test to use? The American...
    • Barnett, V. (1999). Comparative Statistical Inference. New York: John Wiley.
    • Berger, R. L. (1982). Multiparameter hypothesis testing and acceptance sampling. Technometrics, 24, 295-300.
    • Berger, R. L. and Hsu, J. C. (1996). Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science,...
    • Blume, H. H. and Midha, K. K. (1993). Bio-International ’92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. Pharmaceutical...
    • Boddy, A. W., Snikeris, F. C., Kringle, R. O., Wei, G. C. G., Oppermann J. A. and Midha, K. K. (1995). An approach for widening the bioequivalence...
    • Brown, B. W. (1980). The crossover experiment for clinical trials. Biometrics, 36, 69-79.
    • Burns, D. R. and Elswick Jr., R. K. (2001). Equivalence testing with dental clinical trials. Journal of Dental Research, 80, 1513-1517.
    • CDER, Center for Drug Evaluation and Research (2001). Statistical Approaches to Establishing Bioequivalence. Rockville, MD: Food and Drug...
    • CDER, Center for Drug Evaluation and Research (2003). Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered...
    • Chow, S-C. and Liu, J-P. (2000). Design and Analysis of Bioavailability and Bioequivalence studies. New York: Marcel Dekker.
    • Chow, S-C. and Shao, J. (2002). A note on statistical methods for assessing therapeutic equivalence. Controlled Clinical Trials, 23, 515-520.
    • Committee for Proprietary Medicinal Products (CPMP) (2001). Note for Guidance on the Investigation of Bioavailability and Bioequivalence....
    • D’Angelo, G., Potvin, D. and Turgeon, J. (2001). Carry-over effects in bioequivalence studies. Journal of Biopharmaceutical Statistics, 11,...
    • Dragalin, V., Fedorov, V., Patterson, S. and Jones, B. (2003). Kullback-Leibler divergence for evaluating bioequivalence. Statistics in Medicine,...
    • Freeman, P. R. (1989). The performance of the two-stage analysis of two-treatment, two-period crossover trials. Statistics in Medicine, 8,...
    • Garcı́a, G. and Oller, J. M. (2006). What does intrinsic mean in statistical estimation? SORT, 30, 125-170.
    • Girón, F. J., Martı́nez, M. L., Moreno, E. and Torres, F. (2006). Objective testing procedures in linear models: calibration of p-values....
    • Ghosh, P. and Gonen, M. (2008). Bayesian modeling of multivariate average bioequivalence. Statistics in Medicine, 27, 2402-2419.
    • Grieve, A. P. (1985). A Bayesian Analysis of the Two-Period Crossover Design for Clinical Trials. Biometrics, 41, 979-990.
    • Grizzle, J. E. (1965). The two-period change-over design and its use in clinical trials. Biometrics, 21, 467-480.
    • Hoenig, J. M. and Heisey, D. M. (2001). The abuse of power: the pervasive fallacy of power calculations for data analysis. The American Statistician,...
    • Hsu, J. C., Hwang, J. T. G., Liu, H-K. and Ruberg, S. J. (1994). Confidence intervals associated with test for bioequivalence. Biometrika,...
    • Kleijnen, J. P. C. (1999). Validation of models: statistical techniques and data availability. Proceedings of the 1999 Winter Simulation Conference,...
    • Laird, N. M., Skinner, J. and Kenward, M. (1992). An analysis of two-period crossover designs with carryover effects. Statistics in Medicine,...
    • Lehmann, E. L. (1959). Testing Statistical Hypothesis. New York: Wiley.
    • Longford, N. T. (2001). Synthetic estimators with moderating influence: the carry-over in cross-over trials revisited. Statistics in Medicine,...
    • Manoli, T., Gretz, N., Grone, H-J., Kenzelmann, M., Eils, R. and Brors, B. (2006). Group testing for pathway analysis improvescomparabilityofdifferentmicroarraydatasets....
    • Martı́n Andrés, A. and Herranz Tejedor, I. (2002). Equivalence testing for binomial random variables: which test to use? (Letter to the...
    • Mecklin, C. J. (2003). The use of equivalence testing in conjunction with standard hypothesis testing and effect sizes. Journal of Modern...
    • Metzler, C. M. (1974). Bioavailability: a problem of equivalence. Biometrics, 30, 309-317.
    • Midha K. K., Rawson M. J. and Hubbard J. W. (2005). The bioequivalence of highly variable drugs and drug products. International Journal of...
    • Moradi, M., Mousavi, P. and Abolmaesoumi, P. (2006). Pathological distinction of prostate cancer tumors based on DNA microarray data. http://cscbc2006.cs.queensu.ca/assets/documents/Papers/paper127....
    • Moreno, E. and Girón, F. J. (2006). On the frequentist and Bayesian approaches to hypothesis testing. SORT, 30, 3–28.
    • Munk, A. andCzado,C. (1998). Nonparametric validation of similar distributions and assessment of goodness of fit. Journalof theRoyalStatistical...
    • Munk, A. and Pflüger, R. (1999). 1 − α equivariant confidence rules for convex alternatives are α/2–level tests –with applications to...
    • Perlman, M. D. and Wu, L. (1999). The emperor’s new tests. Statistical Science, 14, 355-381.
    • Putt, M. and Chinchilli, V. M. (1999). A mixed effects model for the analysis of repeated measures crossover studies. Statistics in Medicine,...
    • Putt, M. (2005). Comment on ‘Carry-over in cross-over trials in bioequivalence: theoretical concerns and empirical evidence’. Senn S, D’Angelo...
    • Putt, M. (2006). Power to detect clinically relevant carry-over in a series of cross-over studies. Statistics in Medicine, 25, 2567-2586.
    • Racine, A., Grieve, P., Fluhler, H. A. and Smith, F. M. (1986). Bayesian methods in practice: experiences in the pharmaceutical industry....
    • Rao, C. R. (1945). Information and accuracy attainable in the estimation of statistical parameters. Bulletin of the Calcutta Mathematical...
    • Rashid, M. M. (2003). Rank-based tests for non-inferiority and equivalence hypotheses in multi-centre clinical trials using mixed models....
    • Reynolds, M. R. and Deaton, M. L. (1982). Comparisons of some tests for validation of stochastic simulation models. Communications in Statistics...
    • Robinson, A. P. and Froese, R. E. (2004). Model validation using equivalence tests. Ecological Modelling, 176, 349-358.
    • Rodda, B. E. and Davis, R. L. (1980). Determining the probability of an important difference in bioavailability. Clinical Pharmacology and...
    • Salicrú, M., Ocaña, J. and Sánchez, A. (2008). Comparison of lists of genes based on functional profiles. Submitted.
    • Sánchez, A., Salicrú, M. and Ocaña, J. (2007). Statistical methods for the analysis of high-throughput data based on functional profiles...
    • Sánchez, A., Ocaña, J. and Salicrú, M. (2008). goProfiles: an R package for the Statistical Analysis of Functional Profiles. http://estbioinfo.stat.ub.es/pubs/goProfiles-Usersguide.pdf
    • Sargent, R. G. (2005). Verification and validation of simulation models. Proceedings of the 2005 Winter Simulation Conference, M. E. Kuhl,...
    • Schall, R. (1995). Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics,...
    • Schall, R. and Luus, H. G. (1993). On population and individual bioequivalence. Statistics in Medicine, 12, 1109-1124.
    • Schuirmann D. J. (1987). A comparison of the Two One-sided Test procedure and the Power Approach for assessing the equivalence of Average...
    • Sellke, T., Bayarri, M. J. and Berger, O. (2001). Calibration of p values for testing precise null hypotheses. The American Statistician,...
    • Senn, S. (1988). Cross-over trials, carry-over effects and the art of self-delusion. Statistics in Medicine, 7, 1099-1101.
    • Senn, S. (1992). Is the ‘simple carry-over’ model useful? Statistics in Medicine, 11, 715-726.
    • Senn, S. (1996). The AB/BA Cross-over: How to perform the two-stage analysis if you can’t be persuaded that you shouldn’t. Hansen, B and De...
    • Senn, S. (2001). Statistical issues in bioequivalence. Statistics in Medicine, 20, 2785–2799.
    • Senn, S., D’Angelo, G. and Potvin, D. (2004). Carry-over in cross-over trials in bioequivalence: theoretical concerns and empirical evidence....
    • Senn, S., D’Angelo, G. and Potvin, D. (2005). Rejoinder: Dr. Putt’s analysis. Pharmaceutical Statistics, 4, 217-219.
    • Shah, V. P., Yacobi, A., Barr, W. H., Benet, L. Z., Breimer, D., Dobrinska, M. R., Endrenyi, L., Fairweather, W., Gillespie, W., Gonzalez,...
    • Singh, D., Febbo, P. G., Ross, K., Jackson, D. G., Manola, J., Ladd, C., Tamayo, P., Renshaw, A. A., D’Amico, A. V., Richie, J. P., Lander,...
    • Stegner, A. L., Bostrom, A. G. and Greenfield, T. K. (1996). Equivalence testing for use in psychosocial and services research: An introduction...
    • Tothfalusi, L. and Endrenyi, L. (2003). Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharmaceutical...
    • Van Steen, K., Raby, B. A., Molenberghs, G., Thijs, H., De Wit, M. and Peeters M. (2005). An equivalence test for comparing DNA sequences....
    • Wang, W. W., Hwang, J. T. G. and Dasgupta, A. (1999). Statistical tests for multivariate bioequivalence. Biometrika, 86, 395-402.
    • Warner, B. (2002). Equivalence testing. MORS Workshop “Test& Evaluation, Modeling & Simulation and VV&A: Quantifying the Relationship...
    • Westlake, W. J. (1972). Use of confidence intervals in analysis of comparative bioavailability trials. Journal of Pharmaceutical Science,...
    • Wellek, S. (2001). On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures. Statistics...
    • Wellek, S. (2003). Testing Statistical Hypotheses of Equivalence. Boca Raton: Chapman & Hall/CRC.
    • Welsh, J. B., Sapinoso, L. M., Su, A. I., Kern, S. G., Wang-Rodriguez, J., Moskaluk, C. A., Frierson Jr, H. F. and Hampton, G. M. (2001)....
    • Williamson, P. P. (2007). Bayesian equivalence testing for binomial random variables. Journal of Statistical Computation and Simulation, 77,...
    • Zapater, P., Horga, J. F. (1999). Bioequivalencia y Genéricos. Los estudios de Bioequivalencia. I. Una aproximación a sus bases teóricas,...
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