Bioequivalence of Rispen Tablet to Risperdal Tablet (Risperidone 2 mg) |
Cho, Hea-Young
(Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University)
Park, Eun-Ja (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Kang, Hyun-Ah (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Baek, Seung-Hee (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Lee, Suk (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Park, Chan-Ho (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Moon, Jai-Dong (Medical School, Chonnam National University) Lee, Yong-Bok (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) |
1 | G. Mannens, M. Huang, W. Meuldermans, J. Hendricks, R. Woestenborghs and J. Heykants, Absorption, metabolism and excretion of risperidone in humans, Drug Metab. Disposit, 21, 1134-1141 (1993) |
2 | PDR 53 editions 1999, pp. 1432-1436 (1999) |
3 | 식품의약품안전청 고시 제 2002-60호, 생물학적동등성시험 기준 (2002.11.22) |
4 | 식품의약품안전청 고시 제 1999-67호, 의약품임상시험관리기준 (2000.1.4) |
5 | R. Woestenborghs, W. Lorreyne, F.V. Rompaey and J. Heykants, Determination of risperidone and 9-hydroxyri-speridone in plasma, urine and animal tissues by highperformance liquid chromatography, J. Chromatogr. B, 583, 223-230 (1992) DOI ScienceOn |
6 | O.Y. Olesen and K. Linnet, Simplified high-performance liquid chromatographic method for determination of risperidone and 9-hydroxyrisperidone in serum from patients comedicated with other psychotropic drugs, J. Chromatogr. B, 698, 209-216 (1997) DOI ScienceOn |
7 | Statistical Solutions Ltd., Equiv Test 1.0, U.K. (1998) |
8 | Food and Drug Administration (FDA): Guidance for Industry; Waiver of in vivo bioavailability and bioequivalence study for immediate-release solid oral dosage forms based on a biopharmaceutics classification system, Center for Drug Evaluation and Research (CDER), August (2000) |