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Statistical Interpretation of Bioequivalence in 2 × 2 Crossover Design with Missing Observations

2 × 2 교차설계에 의한 생물학적동등성시험에서 결측치가 있을 때의 통계적 해석 방법

  • Published : 2004.10.20

Abstract

Statistical interpretations in a bioequivalence trial are considered and studied when the missing observations occurred in $2\;{\times}\;2$ crossover experiment. Patel (1985) suggested the approximate test procedures for carryover effect and drug effect in $2\;{\times}\;2$ crossover design when some of data are missing in the second period. A modified Patel method is newly proposed to the bioequivalence trial and it is compared with the current method through the simulation study.

Keywords

References

  1. S.C. Chow and J.P. Liu, Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker, New York (2000)
  2. H.I. Patel, Analysis of incomplete data in a two-period crossover design with reference to clinical trials, Biometrika, 72, 411-418 (1965) https://doi.org/10.1093/biomet/72.2.411
  3. S. Park, Y. Choi, N. Lim and H. Shin, Bioequivalence for Crossover Experiment with Missing Observations, The Korean Communications in Statistics, 11, 235-246 (2004) https://doi.org/10.5351/CKSS.2004.11.2.235
  4. D.F. Morrison, A test for equality of means of correlated variates with missing data on one response. Biometrika, 60, 101-105 (1973) https://doi.org/10.1093/biomet/60.1.101
  5. D.J. Schuirmann, A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, 15, 657-680 (1987) https://doi.org/10.1007/BF01068419