Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials

생물학적 동등성 시험에서 추가시험의 일관성 검정에 대한 소고

Ha, Myoung-Ho;Park, Sang-Gue

  • Received : 20110900
  • Accepted : 20111100
  • Published : 2012.01.30


The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.


$2{\times}2$ crossover design;add-on test of bioequivalence;consistency test;significance test


  1. 박상규 (2007). On sample size determination of bioequivalence trials, <한국데이터정보과학회지>, 18, 365-373.
  2. 박상규, 남봉헌, 정윤노, 이재영, 정규진 (2010). 생물학적 동등성 시험의 추가시험에 대한 통계적 고찰, <한국통계학회논문집>, 17, 107-115.
  3. 식품의약품안전청 (2007). 생물학적 동등성 시험기준(제2007-65호).
  4. Canada Department of Health (1992). Guidance for Industry, Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part A: Oral Dosage Formulations Used for Systemic Effects, Canada.
  5. Chow, S. C. and Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, Chapman and Hall CRC.
  6. Japan National Institute of Health, Division of Drugs (2006). Guideline for Bioequivalence Studies of Generic Products, Japan.


Supported by : 중앙대학교