Kim, Mi Jo
(Department of Clinical Pharmacology and Therapeutics, Asan Medical Center)
Kim, Yo Han (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) Choi, Hee Youn (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) Jeon, Hae Sun (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) Noh, Yook Hwan (Department of Pharmacology, Inje University College of Medicine) Lim, Hyeong-Seok (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) Bae, Kyun-Seop (Department of Clinical Pharmacology and Therapeutics, Asan Medical Center) |
1 | Davit BM, Conner DP, Fabian-Fritsch B, Haidar SH, Jiang X, Patel DT, Seo PR, Suh K, Thompson CL, Yu LX. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications. AAPS J, 2008;10(1):148-156. DOI |
2 | Karalis V, Symillides M, Macheras P. Bioequivalence of highly variable drugs: a comparison of the newly proposed regulatory approaches by FDA and EMA. Pharm Res, 2012;29(4):1066-1077. DOI ScienceOn |
3 | Dooley M, Spencer CM, Dunn CJ. Aceclofenac: a reappraisal of its use in the management of pain and rheumatic disease. Drugs, 2001;61(9):1351-1378. DOI ScienceOn |
4 | Brogden RN, Wiseman LR. Aceclofenac. A review of its pharmacodynamic properties and therapeutic potential in the treatment of rheumatic disorders and in pain management. Drugs, 1996;52(1):113-124. DOI ScienceOn |
5 | Melilli B, Piazza C, Vitale DC, Marano MR, Pecori A, Mattana P, Volsi VL, Iuculano C, Cardi F, Drago F. Human pharmacokinetics of the muscle relaxant, eperisone hydrochloride by liquid chromatography-electrospray tandem mass spectrometry. Eur J Drug Metab Pharmacokinet, 2011;36(2):71-78. DOI ScienceOn |
6 | Sartini S, Guerra L. Open experience with a new myorelaxant agent for low back pain. Adv Ther, 2008;25(10):1010-1018. DOI ScienceOn |
7 | Myonal drug information http://www.eisai.jp/ medical/products/di/EPI/MYO_T-G_EPI.pdf [Online] (last visited on Nov 15 2013). |
8 | Tothfalusi L, Endrenyi L. Sample sizes for designing bioequivalence studies for highly variable drugs. J Pharm Pharm Sci, 2012;15(1): 73-84. |
9 | Kim MJ, Lim HS, Noh YH, Kim YH, Choi HY, Park KM, Kim SE, Bae KS. Pharmacokinetic interactions between eperisone hydrochloride and aceclofenac: a randomized, open-label, crossover study of healthy korean men. Clin Ther, 2013;35(10):1528-1535. DOI ScienceOn |
10 | World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ, 2001;79 (4):373-374. |
11 | R.BORT XP, E.CARRASCO, M.J.GOMEZLECHEON, J.V.CASTEL. Metabolism of aceclofenac in humans. Drug metabolism and disposition, 1996;24(8):834-841. |
12 | Agency EM. Guideline on the Investigation of Bioequivalence. Committee for Medicinal Products for Human Use, CHMP. London2010. |