- Volume 19 Issue 1
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.
- 박상규 (2007). On sample size determination of bioequivalence trials, <한국데이터정보과학회지>, 18, 365-373.
- 박상규, 남봉헌, 정윤노, 이재영, 정규진 (2010). 생물학적 동등성 시험의 추가시험에 대한 통계적 고찰, <한국통계학회논문집>, 17, 107-115.
- 식품의약품안전청 (2007). 생물학적 동등성 시험기준(제2007-65호).
- 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.
- Chow, S. C. and Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, Chapman and Hall CRC.
- Japan National Institute of Health, Division of Drugs (2006). Guideline for Bioequivalence Studies of Generic Products, Japan.
Supported by : 중앙대학교