Bioequivalence Of SudoTM Ranitidine Hydrochloride Tablet to CuranTM Tablet (Ranitidine Hydrochloride 150 mg)
![]() |
Lee, Sun-Neo
(Department of Drug Development Service, BioCore Co., Ltd.)
Ko, Youn-Jung (Department of Drug Development Service, BioCore Co., Ltd.) Kang, Seung-Woo (Department of Drug Development Service, BioCore Co., Ltd.) Yoon, Seo-Hyun (Quality Control Department, SUDO Pharm. Ind. Co., Ltd.) Park, Moo-Sin (Quality Control Department, SUDO Pharm. Ind. Co., Ltd.) Lee, Ye-Ri (Department of Drug Development Service, BioCore Co., Ltd.,Quality Control Department, SUDO Pharm. Ind. Co., Ltd.) Lee, Kyung-Ryul (Department of Drug Development Service, BioCore Co., Ltd.,Quality Control Department, SUDO Pharm. Ind. Co., Ltd.) Lee, Hee-Joo (Department of Drug Development Service, BioCore Co., Ltd.,Quality Control Department, SUDO Pharm. Ind. Co., Ltd.) |
1 | 일본의약품집 2293-2295 (1997) |
2 | S.A. Bawazir, M.W. Gouda, Y.M. El-Sayed, K.I. Al-Khamis, MJ. Al-Yamani, E.M. Niazy and K.A. Al-Rashood, Comparative bioavailability of two tablet formulations of ranitidine hydrochloride in healthy volunteers. Int. J. Clin. Pharmacal. Ther., 36, 270-274 (1998) |
3 | 식품의약품안전청 고시 제 2002-60호, 생물학적동등성시험기준(2002.11.22) |
4 | 대한약전 제8개정(2002) |
5 | 영국약전(2002) |
6 | 식품의약품안전청 고시 제 2002-61호, 의약품동등성시험관리규정 (20020.11.22) |
7 | ICH guideline; Validation of analytical procedures: Methodology |
8 | Y.J. Lee, Y.G Kim, M.G Lee, S.J. Chung, M.H. Lee and C.K. Shim, Analysis of bioequivalence study using logtransformed model, Yakakhoji, 44, 308-314 (2000) 과학기술학회마을 |
![]() |