Statistical Considerations of the Add-On Test on Bioequivalence Trial |
Park, Sang-Gue
(Department of Statistics, Chung-Ang University)
Nam, Bong-Hyun (International Trade and Statistics Office, Korea Food & Drug Administration) Chung, Yun-Ro (Department of Biostatistics, University of North Carolina) Lee, Jae-Young (Business Process Innovation Team(DS), Samsung Electronics Co., Ltd.) Jeong, Gyu-Jin (Department of Business statistics, Han-Nam university) |
1 | Chow, S. C. and Liu, J. P. (2008), Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, Chapman & Hall/CRC. |
2 | 식품의약품안전청 (2007). 생물학적 동등성 시험기준(제 2007-65호) |
3 | 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. |