Browse > Article

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)
Publication Information
Journal of the Korean Statistical Society / v.35, no.3, 2006 , pp. 239-250 More about this Journal
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
$2{\times}2$ crossover design; population bioequivalence; individual bioequivalence; Markov chain Monte Carlo; Metropolis-Hastings algorithm;
Citations & Related Records
연도 인용수 순위
  • Reference
1 ANDERSON, S. AND HAUCK, W. W. (1990). 'Consideration of individual bioequivalence', Journal of Pharmacokinetics and Biopharmaceutics, 18, 259-273   DOI
2 CHEN, M. L. (1997). 'Individual bioequivalence-a regulatory update', Journal of Biopharmaceutical Statistics, 7, 5-11   DOI   ScienceOn
3 CHOW, S-C. AND LIU, J-P. (2000). Design and Analysis of Bioavailability and Bioequivalence Studies, 2nd ed., Marcel Dekker, New York
4 FDA DRAFT GUIDANCE (1997). Draft guidance on in vivo bioequivalence studies based on population and individual bioequivalence approaches, Division of bioequivalence, office of generic drugs, center for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
5 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   DOI   ScienceOn
6 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
7 SCHALL, R. (1995). 'Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar', Biometrics, 51, 615-626   DOI   ScienceOn
8 GRIEVE, A. P. (1985). 'A Bayesian analysis of the two-period crossover design for clinical trials', Biometrics, 41, 979-990   DOI   ScienceOn
9 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   DOI
10 WANG, W. (1997). 'Optimal unbiased tests for equivalence in intrasubject variability', Journal of the American Statistical Association, 92, 1163-1170   DOI
11 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   DOI   ScienceOn
12 LIU, J-P. (1991), 'Bioequivalence and intrasubject variability', Journal of Biopharmaceutical Statistics, 1, 205-219   DOI   ScienceOn
13 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   DOI   ScienceOn
14 BERGER, J. O. (1985). Statistical Decision Theory and Bayesian Analysis, Springer-Verlag, New York
15 HASTINGS, W. K. (1970). 'Monte Carlo sampling methods using Markov chains and their applications', Biometrika, 57, 97-109   DOI   ScienceOn
16 HILLS, M. AND ARMITAGE, P. (1979). 'The two-period cross-over clinical trial', British Journal of Clinical Pharmacology, 8, 7-20   DOI