ASSESSING POPULATION BIOEQUIVALENCE IN A $2{\times}2$ CROSSOVER DESIGN WITH CARRYOVER EFFECT IN A BAYESIAN PERSPECTIVE

  • Oh Hyun-Sook (Department of Applied Statistics, Kyungwon University)
  • Published : 2006.09.01

Abstract

A $2{\times}2$ crossover design including carryover effect is considered for assessment of population bioequivalence of two drug formulations in a Bayesian framework. In classical analysis, it is complex to deal with the carryover effect since the estimate of the drug effect is biased in the presence of a carryover effect. The proposed method in this article uses uninformative priors and vague proper priors for objectiveness of priors and the posterior probability distribution of the parameters of interest is derived with given priors. The posterior probabilities of the hypotheses for assessing population bioequivalence are evaluated based on a Markov chain Monte Carlo simulation method. An example with real data set is given for illustration.

Keywords

References

  1. ANDERSON, S. AND HAUCK, W. W. (1990). 'Consideration of individual bioequivalence', Journal of Pharmacokinetics and Biopharmaceutics, 18, 259-273 https://doi.org/10.1007/BF01062202
  2. BERGER, J. O. (1985). Statistical Decision Theory and Bayesian Analysis, Springer-Verlag, New York
  3. CHEN, K-W., LI, G., SUN, Y. AND CHOW, S-C. (1996). 'A confidence region approach for assessing equivalence in variability of bioavailability', Biometrical Journal, 38, 475-487 https://doi.org/10.1002/bimj.4710380413
  4. CHEN, M. L. (1997). 'Individual bioequivalence-a regulatory update', Journal of Biopharmaceutical Statistics, 7, 5-11 https://doi.org/10.1080/10543409708835162
  5. CHOW, S-C. AND LIU, J-P. (2000). Design and Analysis of Bioavailability and Bioequivalence Studies, 2nd ed., Marcel Dekker, New York
  6. FDA DRAFT GUIDANCE (1997). Draft guidance on in vivo bioequivalence studies based on population and individual bioequivalence approaches, Division of bioequivalence, office of generic drugs, center for drug evaluation and research, U.S. Food and Drug Administration, Maryland
  7. GRIEVE, A. P. (1985). 'A Bayesian analysis of the two-period crossover design for clinical trials', Biometrics, 41, 979-990 https://doi.org/10.2307/2530969
  8. HASTINGS, W. K. (1970). 'Monte Carlo sampling methods using Markov chains and their applications', Biometrika, 57, 97-109 https://doi.org/10.1093/biomet/57.1.97
  9. HAUCK, W. W., BOIS, F. Y., HYSLOP, T., GEE, L. AND ANDERSON, S. (1997). 'A parametric approach to population bioequivalence', Statistics in Medicine, 16, 441-454 https://doi.org/10.1002/(SICI)1097-0258(19970228)16:4<441::AID-SIM390>3.0.CO;2-F
  10. HILLS, M. AND ARMITAGE, P. (1979). 'The two-period cross-over clinical trial', British Journal of Clinical Pharmacology, 8, 7-20 https://doi.org/10.1111/j.1365-2125.1979.tb05903.x
  11. LIU, J-P. (1991), 'Bioequivalence and intrasubject variability', Journal of Biopharmaceutical Statistics, 1, 205-219 https://doi.org/10.1080/10543409108835019
  12. LIU, J -P. AND CHOW, S-C. (1992). 'On the assessment of variability in bioavailability/bioequivalence studies', Communications in Statistics-Theory and Methods, 21, 2591-2607 https://doi.org/10.1080/03610929208830932
  13. OH, H. S., Ko, S-G. AND OH, M-S. (2003). 'A Bayesian approach to assessing population bioequivalence in a 2 $\times$ 2 crossover design', Journal of Applied Statistics, 30, 881-891 https://doi.org/10.1080/0266476032000117131
  14. PATNAIK, R. N., LESKO, L. J., CHEN, M. L., WILLIAMS, R. L. AND THE FDA POPULATION AND INDIVIDUAL BIOEQUIVALENCE WORKING GROUP (1997). 'Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics', Clinical Pharmacokinetics, 33, 1-6
  15. SCHALL, R. (1995). 'Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar', Biometrics, 51, 615-626 https://doi.org/10.2307/2532949
  16. WANG, W. (1997). 'Optimal unbiased tests for equivalence in intrasubject variability', Journal of the American Statistical Association, 92, 1163-1170 https://doi.org/10.2307/2965582