Communications for Statistical Applications and Methods

  • 제27권6호
  • /
  • Pages.641-647
  • /
  • 2020
  • /
  • 2287-7843(pISSN)
  • /
  • 2383-4757(eISSN)
한국통계학회 (The Korean Statistical Society)
권호 표지
DOI QR코드

DOI QR Code

Bioequivalence trial with two generic drugs in 2 × 3 crossover design with missing data

  • Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University) ;
  • Kim, Seunghyo (Department of Statistics, Graduate School of Chung-Ang University) ;
  • Choi, Ikjoon (Department of Pharmaceutical Industrial Management, Graduate School of Chung-Ang University)
  • 투고 : 2020.07.27
  • 심사 : 2020.09.04
  • 발행 : 2020.11.30
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

The 2 × 3 crossover design, a modified version of the 3 × 3 crossover design, is considered to compare the bioavailability of two generic candidates with a reference drug. The 2 × 3 crossover design is more economically favorable due to decrease in the number of sequences, rather than conducting a 3×3 crossover trial or two separate 2 × 2 crossover trials. However, when using a higher-order crossover trial, the risk of drop-outs and withdrawals of subjects increases, so the suitable statistical inferences for missing data is needed. The bioequivalence model of a of 2×3 crossover trial with missing data is defined and the statistical procedures of assessing bioequivalence is proposed. An illustrated example of the 2 × 3 trial with missing data is also presented with discussion.

키워드

참고문헌

  1. Chow SC and Liu JP (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, Marcel Dekker, New York.
  2. Chow SC and Shao J (1997). Statistical methods for two-sequence three-period cross-over designs with incomplete data, Statistics in Medicine, 16, 1031-1039. https://doi.org/10.1002/(SICI)1097-0258(19970515)16:9<1031::AID-SIM519>3.0.CO;2-6
  3. Fuller WA and Battese GE (1973). Transformations for estimation of linear models with nested error structures, Journal of the American Statistical Association, 68, 636-632.
  4. Grizzle JE (1965). The two-period change-over design and its use in clinical trials, Biometrics, 21, 467-480. https://doi.org/10.2307/2528104
  5. Lee YJ, Lee MG, Chung SJ, Lee MH, and Shim CK (1998). Statistical analysis of three sequence three periods bioequivalence model: example of bioequivalence test of ondansetron formulations, The Journal of Korean Pharmaceutical Science, 28, 35-42.
  6. Lim NK, Park SG, and Stanek E (2005). Bioequivalence trials with the incomplete 3 × 3 crossover design, Biometrical Journal, 47, 635-643. https://doi.org/10.1002/bimj.200410144
  7. Oh HS, Ko SG, Kim JI, and Park SG (1999). Assessing bioequivalence with two new drug formulations and a reference formulation, The Korean Journal of Applied Statistics, 12, 241-252.
  8. Park SG (2014). Statistical Methods for Bioequivalence Trials, Freedom Academy, Paju, Korea.