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Assessing Average Bioequivalence for 2×2 Crossover Design with Covariates

공변량을 고려한 2×2 교차설계법에 평균 생물학적 동등성 평가

Jeong, Gyu-Jin;Park, Sang-Gue;Kim, Kwan-Yup
정규진;박상규;김관엽

  • Received : 20101000
  • Accepted : 20101100
  • Published : 2011.02.28

Abstract

The primary variables are often systematically related to other influences apart from drug effect. For instance, there may be relationships to covariates such as health conditions or prognostic factors. When a $2{\times}2$ crossover experiment for bioequivalence is designed, the statistical adjustment for the influence of covariates should be considered if some covariates influence the drug effect. Statistical inference for assessing average bioequivalence for a $2{\times}2$ crossover design with covariates is given and an illustrated example is presented with discussion.

Keywords

$2{\times}2$ crossover design;bioavailability;average bioequivalence;covariates

References

  1. 식품의약품안전청 (2010). 생물학적동등성시험기준(고시 제2010-43호).
  2. Chow, S. C. and Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, Chapman & Hall/CRC.
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  4. Patel, H. I. (1983). Use of baseline measurements in the two-period crossover design, Communications in Statistics, Theory & Methods, 12, 2693–2712.
  5. Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability, Journal of Pharmacokinetics and Pharmacodynamics, 15, 657–680.

Cited by

  1. On Evaluation of Bioequivalence for Highly Variable Drugs vol.24, pp.6, 2011, https://doi.org/10.5351/KJAS.2011.24.6.1055

Acknowledgement

Supported by : 한남대학교