[1] De-Haan RM, Vanden-Bosch WD, Metzler CM.Clindamycin serum concentrations after administration of clindamycin palmitate with food[J]. J Clin Pharmacol New Drugs, 1972, 12(5): 205-211. [2] Batzias GC, Delis GA, Athanasiou LV.Clindamycin bioavailability and pharmacokinetics following oral administration of clindamycin hydrochloride capsules in dogs[J]. The Veterinary Journal, 2005, 170: 339-345. [3] Gatfi G, Flaherty J, Bubp J, et al.Comparative study of bioavai-labilities and pharmacokinetics of clindamycin in healthy volunteers and patients with AIDS[J]. Antimicrobial Agents and Chemotherapy, 1993, 37(5): 1137-1143. [4] Carrasco-Portugal MC, Miguel L, Flores-Murrietaa FJ.Evaluation of gender in the oral pharma-cokinetics of clindamycin in humans[J]. Biopharm Drug Dispos, 2008, 29: 427-430. [5] Flaheryu JF, Rodondi LC, Guglielmo BJ, et al.Comparative pharmacokinetics and serum inhibitory activity of clindamycin in different dosing regimens[J]. Antimicrobial Agents and Chemot-herapy, 1988, 32(12): 1825-1829. [6] Dan M, Yampolsky E, Poch F.Serum concentrations and ex vivo inhibitory / bactericidal activity of clindamycin after administration of two oral dosages[J]. Chemotherapy, 1997, 43(4) : 227-231. [7] Li J, Wang N, Zhang ZJ, et al.Pharmacokinetics and bioequivalence study of clindamycin hydrochloride formulations after single-dose administration in healthy Chinese male volunteers[J]. Arzneimittel-Forschung (Drug Research), 2008, 58(7): 358-362. [8] Zhang DS, Wang C, Yao SC, et al.Study on the dissolution charact-eristics of domestic cefradine granules in vitro and its influence on pharmacokinetics in vivo using physiologically based pharma-cokinetics model prediction[J]. Chinese Journal of New Drugs(中国新药杂志), 2019, 28(5): 536-540. [9] Wang C, Hu CQ, Xu MZ.Study on bioavailability of clavulanic acid in amoxicillin-clavulanic acid preparations of different ratios[J]. Chin-ese Journal of New Drugs(中国新药杂志), 2019, 28(18): 2213-2216. [10] Wang C, Xu MZ, Hu CQ.On effectiveness of cefixime oral solid preparations by computer simulation[J]. Chinaese Pharmaceutical Affairs(中国药事), 2019, 33(11):1270-1279. [11] China Food and Drug Administration. The 3 guidance for general oral solid preparations reference preparation selection and determin-ation[EB/OL].(2016-03-18)[2021-01-05]. http://www.sda.gov.cn/WS01/CL0087/147583.html. [12] China Food and Drug Administration. The guidance for dissolution-test technique of common oral solid preparation[EB/OL].(2015-02-05)[ 2021-01-05]. http://www.sda.gov.cn/WS01/CL1757/114288.html. [13] EMA. Scientific guidance on post-authorisation efficacystudies[EB/OL]. (2016-10-12)[2021-01-05]. http://www.ema.europa. eu/ema/pages/includes/document/open_document.jsp?webContentId= WC500219040. [14] Okumu A, DiMaso M, Löbenberg R. Computer simulations using GastroPlus to justify a biowaiver for etoricoxib solid oral drug products[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2009, 72(1): 91-98. [15] Kovacević I, Parojcić J, Homsek I, et al.Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation[J]. Molecular Pharmaceutics, 2009, 6(1): 40-47. |