Bioequivalence of Stapin ER Tablet to Splendil ER Tablet (Felodipine 5 mg)
![]() |
Cho, Hea-Young
(College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University)
Kang, Hyun-Ah (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University) Lee, Suk (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University) Baek, Seung-Hee (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University) Park, Eun-Ja (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University) Choi, Hoo-Kyun (College of Pharmacy, Chosun University) Moon, Jai-Dong (Medical School, Chonnam National University) Lee, Yong-Bok (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University) |
1 | B. Edgar, C. G. Regardh, G. Johnsson, L. Johansson, P. Lundborg, I. Lotberg and O. Ronn, Felodipine kinetics in healthy men, Clin. Pharmacal. Then, 38, 205-211 (1985) DOI ScienceOn |
2 | J.M. Petry, P.M. de Coster, J. Renhin, Hemodynamic effects of felodipine at rest and during exercise in exertional angina pectoris, Am. J. Cardiol., 52, 453-457 (1983) DOI ScienceOn |
3 | Parfitt, K., Martindale - The complete Drug Reference 32nd ed., Pharmaceutical Press, London, p. 867 (1999) |
4 | 식품의약품안전청 고시 제 2002-60호, 생물학적동등성시험 기준(2002. 11. 22) |
5 | 식품의약품안전청 고시 제 1999-67호, 의약품 임상시험관리기준 (2000. 1. 4) |
6 |
L. Weidolf, Bimodal column switching liquid chromatographic assay of six metabolites of [ |
7 | P.A. Soons, M.C.M. Roosemalen and D.D. Breimer, Enantioselective determination of felodipine and other chiral dihydripyrine calcium entry blockers in human plasma, J. Chromatogt: B, 528, 343-356 (1990) DOI ScienceOn |
8 | Statistical Solutions Ltd., Equiv Test 1.0, U.K.(1998) |
9 | Food and Drug Administration (FDA): Guidance for Industry; Waiver of in viva 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) |
![]() |