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Volumn 100, Issue 1, 2011, Pages 22-33

Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride

Author keywords

Absorption; Biopharmaceutics classification system (BCS); Ciprofloxacin; Dissolution; Permeability; Regulatory science; Solubility

Indexed keywords

CIPROFLOXACIN; EXCIPIENT;

EID: 78650060225     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22259     Document Type: Article
Times cited : (95)

References (94)
  • 1
    • 3843072170 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol
    • Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Möller H, Olling M, Shah VP, Barends DM. 2004. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol. J Pharm Sci 93: 1945-1956.
    • (2004) J Pharm Sci , vol.93 , pp. 1945-1956
    • Vogelpoel, H.1    Welink, J.2    Amidon, G.L.3    Junginger, H.E.4    Midha, K.K.5    Möller, H.6    Olling, M.7    Shah, V.P.8    Barends, D.M.9
  • 2
    • 85031247270 scopus 로고    scopus 로고
    • Cipro® (ciprofloxacin hydrochloride tablets) Cipro® (ciprofloxacin*) oral suspension. Food and drug administration. (accessed 12-28-2009).
    • Cipro® (ciprofloxacin hydrochloride tablets) Cipro® (ciprofloxacin*) oral suspension. Food and drug administration. (accessed 12-28-2009).
  • 3
    • 85031245555 scopus 로고    scopus 로고
    • Cipro® medication guide, revised October 2008. Bayer health care under lincence of schering corporation. (accessed 12-28-2009).
    • Cipro® medication guide, revised October 2008. Bayer health care under lincence of schering corporation. (accessed 12-28-2009).
  • 4
    • 85031273654 scopus 로고    scopus 로고
    • Ciprofloxacin. In clinical pharmacology [on line, restricted access] Gold Standard/ Elsevier (updated 2006 July 11th, accessed 2008 Nov 22). Available from:
    • Ciprofloxacin. In clinical pharmacology [on line, restricted access] Gold Standard/ Elsevier (updated 2006 July 11th, accessed 2008 Nov 22). Available from: .
  • 5
    • 0031945541 scopus 로고    scopus 로고
    • Ciprofloxacin overdose: Acute renal failure with prominent apoptotic changes
    • Dharnidharka VR, Nadeau K, Cannon CL, Harris HW, Rosen S. 1998. Ciprofloxacin overdose: Acute renal failure with prominent apoptotic changes. Am J Kidney 31: 710-712.
    • (1998) Am J Kidney , vol.31 , pp. 710-712
    • Dharnidharka, V.R.1    Nadeau, K.2    Cannon, C.L.3    Harris, H.W.4    Rosen, S.5
  • 6
    • 23244445374 scopus 로고    scopus 로고
    • Fluoroquinolone induced acute renal failure. General review about a case report with crystalluria due to ciprofloxacin
    • Montagnac R, Briat C, Schillinger F, Sartelet H, Birembaut P, Daudon M. 2005. Fluoroquinolone induced acute renal failure. General review about a case report with crystalluria due to ciprofloxacin. Nephrol Ther 1: 44-51.
    • (2005) Nephrol Ther , vol.1 , pp. 44-51
    • Montagnac, R.1    Briat, C.2    Schillinger, F.3    Sartelet, H.4    Birembaut, P.5    Daudon, M.6
  • 8
    • 0026752193 scopus 로고
    • Ciprofloxacin-induced acute interstitial nephritis
    • Bailey JR, Trott SA, Philbrick JT. 1992. Ciprofloxacin-induced acute interstitial nephritis. Am J Nephrol 12: 271-273.
    • (1992) Am J Nephrol , vol.12 , pp. 271-273
    • Bailey, J.R.1    Trott, S.A.2    Philbrick, J.T.3
  • 9
    • 85031251642 scopus 로고    scopus 로고
    • The United States pharmacopeia -The National Formulary
    • USP 32-NF 27., Rockville, MD, The United States Pharmacopeial Convention, Inc.
    • USP 32-NF 27. 2009. The United States pharmacopeia -The National Formulary. Rockville, MD: The United States Pharmacopeial Convention, Inc.
    • (2009)
  • 10
    • 77952919960 scopus 로고    scopus 로고
    • European Pharmacopoeia
    • European Directorate for the Quality of Medicines & HealthCare., 6th edition., Strasbourg, France, Council of Europe.
    • European Directorate for the Quality of Medicines & HealthCare. 2008. European Pharmacopoeia, 6th edition. Strasbourg, France: Council of Europe.
    • (2008)
  • 11
    • 0033408486 scopus 로고    scopus 로고
    • Formulation of a neutral solution of ciprofloxacin upon complexation with aluminum
    • Allemandi DA, Alovero F, Manzo RH. 1999. Formulation of a neutral solution of ciprofloxacin upon complexation with aluminum. Farmaco [Prat] 54: 758-760.
    • (1999) Farmaco [Prat] , vol.54 , pp. 758-760
    • Allemandi, D.A.1    Alovero, F.2    Manzo, R.H.3
  • 12
    • 19944432090 scopus 로고    scopus 로고
    • Ototopic ciprofloxacin in a glycerin vehicle for the treatment of acute external otitis
    • - 628, 630 passim.
    • Olivera ME, Bistoni A, Anun H, Salinas A, Manzo RH. 2004. Ototopic ciprofloxacin in a glycerin vehicle for the treatment of acute external otitis. Ear Nose Throat J 83: 625-626 628, 630 passim.
    • (2004) Ear Nose Throat J , vol.83 , pp. 625-626
    • Olivera, M.E.1    Bistoni, A.2    Anun, H.3    Salinas, A.4    Manzo, R.H.5
  • 13
    • 85031243635 scopus 로고    scopus 로고
    • Preparación de complejos en estado sólido de clorhidratos de antimicrobianos fluoroquiolónicos (AMFQs) con aluminio. Argentinian Patent AR007762B1.
    • Manzo RH, Mazzieri MR, Olivera ME. 2005. Preparación de complejos en estado sólido de clorhidratos de antimicrobianos fluoroquiolónicos (AMFQs) con aluminio. Argentinian Patent AR007762B1.
    • (2005)
    • Manzo, R.H.1    Mazzieri, M.R.2    Olivera, M.E.3
  • 15
    • 0035985895 scopus 로고    scopus 로고
    • Determination of lipophilicity of two quinolone antibacterials, ciprofloxacin and grepafloxacin, in the protonation equilibrium
    • Sun J, Sakai S, Tauchi Y, Deguchi Y, Chen J, Zhang R, Morimoto K. 2002. Determination of lipophilicity of two quinolone antibacterials, ciprofloxacin and grepafloxacin, in the protonation equilibrium. Eur J Pharm Biopharm 54: 51-58.
    • (2002) Eur J Pharm Biopharm , vol.54 , pp. 51-58
    • Sun, J.1    Sakai, S.2    Tauchi, Y.3    Deguchi, Y.4    Chen, J.5    Zhang, R.6    Morimoto, K.7
  • 17
    • 0023906974 scopus 로고
    • Inhibitory effects of quinolone antibacterial agents on γ-aminobutyric acid binding to receptor sites in rat brain membranes
    • Tsuji A, Sato H, Kume Y, Tamai I, Okezaki E, Nagata O, Kato H. 1988. Inhibitory effects of quinolone antibacterial agents on γ-aminobutyric acid binding to receptor sites in rat brain membranes. Antimicrob Agents Chemother 32: 190-194.
    • (1988) Antimicrob Agents Chemother , vol.32 , pp. 190-194
    • Tsuji, A.1    Sato, H.2    Kume, Y.3    Tamai, I.4    Okezaki, E.5    Nagata, O.6    Kato, H.7
  • 19
    • 85031276222 scopus 로고    scopus 로고
    • Caracterización Biofarmacéutica y Farmacotécnica de Derivados Farmacéuticos de Anticrobianos Fluoroquinolónicos. [Master Thesis]. Córdoba-Argentina, Universidad Nacional de Córdoba.
    • Romañuk CB. Caracterización Biofarmacéutica y Farmacotécnica de Derivados Farmacéuticos de Anticrobianos Fluoroquinolónicos. [Master Thesis]. Córdoba-Argentina, Universidad Nacional de Córdoba.
    • Romañuk, C.B.1
  • 20
    • 85031273560 scopus 로고    scopus 로고
    • pION INC, 2003 pION INC, 2003. Molecule of the Month-Ciprofloxacin.HCl. (Accessed 09-10-2008).
    • pION INC, 2003 pION INC, 2003. Molecule of the Month-Ciprofloxacin.HCl. (Accessed 09-10-2008).
  • 21
    • 0028632806 scopus 로고
    • El perfil de solubilidad de la ciprofloxacina en función del pH
    • Fallati C, Ahumada A, Manzo R. 1994. El perfil de solubilidad de la ciprofloxacina en función del pH. Acta Farm Bon 13: 73-77.
    • (1994) Acta Farm Bon , vol.13 , pp. 73-77
    • Fallati, C.1    Ahumada, A.2    Manzo, R.3
  • 22
    • 70349254015 scopus 로고    scopus 로고
    • Characterization of the solubility and solid-state properties of saccharin salts of fluoroquinolones
    • Romañuk CB, Garro Linck Y, Chattah AK, Monti GA, Manzo RH, Olivera ME. 2009. Characterization of the solubility and solid-state properties of saccharin salts of fluoroquinolones. J Pharm Sci 98: 3788-3801.
    • (2009) J Pharm Sci , vol.98 , pp. 3788-3801
    • Romañuk, C.B.1    Garro Linck, Y.2    Chattah, A.K.3    Monti, G.A.4    Manzo, R.H.5    Olivera, M.E.6
  • 23
    • 0028329527 scopus 로고
    • The effect of temperature and pH on the solubility of quinolone compounds: Estimation of heat of fusion
    • Yu X, Zipp GL, Davison GWR III. 1994. The effect of temperature and pH on the solubility of quinolone compounds: Estimation of heat of fusion. Pharm Res 11: 522-527.
    • (1994) Pharm Res , vol.11 , pp. 522-527
    • Yu, X.1    Zipp, G.L.2    Davison III, G.W.R.3
  • 24
    • 0004144140 scopus 로고    scopus 로고
    • The extra pharmacopoeia
    • Martindale., 31st edition., London, UK, Royal Pharmaceutical Society.
    • Martindale. 1996. The extra pharmacopoeia, 31st edition. London, UK: Royal Pharmaceutical Society.
    • (1996)
  • 25
    • 85031241718 scopus 로고    scopus 로고
    • [15th] Essential Medicines WHO Model List (revised March 2007). .
    • [15th] Essential Medicines WHO Model List (revised March 2007). .
  • 26
    • 85031276071 scopus 로고    scopus 로고
    • Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina ANMAT. (assessed 12/21/2009).
    • Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina ANMAT. (assessed 12/21/2009).
  • 27
    • 85031268204 scopus 로고    scopus 로고
    • Rote Liste ® Arzneimittelsverzeichnis für Deutschland (einschließlich EU-Zulassungen und bestimmter Medizinprodukte). Service GmbH Frankfurt/Main:. (accessed 06-06-2008).
    • Rote Liste ® Arzneimittelsverzeichnis für Deutschland (einschließlich EU-Zulassungen und bestimmter Medizinprodukte). Service GmbH Frankfurt/Main:. (accessed 06-06-2008).
  • 28
    • 85031252431 scopus 로고    scopus 로고
    • Laegemiddel Styrelson Danish Medicines Agency. (accessed 06-09-2008).
    • Laegemiddel Styrelson Danish Medicines Agency. (accessed 06-09-2008).
  • 29
    • 85031250564 scopus 로고    scopus 로고
    • National Agency for Medicines, Helsinki, Finland: The National Agency for Medicines responsibilities are to maintain and promote the safety and safe use of medicinal products, medical devices and blood products. (accessed 06-11-2008).
    • National Agency for Medicines, Helsinki, Finland: The National Agency for Medicines responsibilities are to maintain and promote the safety and safe use of medicinal products, medical devices and blood products. (accessed 06-11-2008).
  • 30
    • 85031241112 scopus 로고    scopus 로고
    • VIDAL L'information de référence sur les produits de santé. (accessed 06-11-2008).
    • VIDAL L'information de référence sur les produits de santé. (accessed 06-11-2008).
  • 31
    • 85031262752 scopus 로고    scopus 로고
    • College ter Beoordeling van Geneesmiddelen-Medicines Evaluation Board of The Netherlands. (accessed 06-06-2008).
    • College ter Beoordeling van Geneesmiddelen-Medicines Evaluation Board of The Netherlands. (accessed 06-06-2008).
  • 32
    • 85031274613 scopus 로고    scopus 로고
    • Statens legemiddelverk, Norvegian Medicines Agency. (accessed 06-11-2008).
    • Statens legemiddelverk, Norvegian Medicines Agency. (accessed 06-11-2008).
  • 33
    • 85031261318 scopus 로고    scopus 로고
    • Agencia Española de,Medicamentos y Productos Sanitarios. (accessed 03-03-2008).
    • Agencia Española de, Medicamentos y Productos Sanitarios. (accessed 03-03-2008).
  • 34
    • 85031251099 scopus 로고    scopus 로고
    • Läkemedelsverket Medical Product Agency, Sweden. (accessed 06-12-2008).
    • Läkemedelsverket Medical Product Agency, Sweden. (accessed 06-12-2008).
  • 35
    • 85031255428 scopus 로고    scopus 로고
    • The medicines information web site provided by Datapharm Communications Ltd. (accessed 06-12-2008).
    • The medicines information web site provided by Datapharm Communications Ltd. (accessed 06-12-2008).
  • 36
    • 85031251651 scopus 로고    scopus 로고
    • U.S. National library of medicine. Daily Med current medication information. National Institutes of Health, Health & Human Services. (accessed 06-12-2008).
    • U.S. National library of medicine. Daily Med current medication information. National Institutes of Health, Health & Human Services. (accessed 06-12-2008).
  • 43
    • 0022001681 scopus 로고
    • Effect of standard breakfast on drug absorption and multiple-dose pharmacokinetics of ciprofloxacin
    • Ledergerber B, Bettex JD, Joos B, Flepp M, Luthy R. 1985. Effect of standard breakfast on drug absorption and multiple-dose pharmacokinetics of ciprofloxacin. Antimicrob Agents Chemother 27: 350-352.
    • (1985) Antimicrob Agents Chemother , vol.27 , pp. 350-352
    • Ledergerber, B.1    Bettex, J.D.2    Joos, B.3    Flepp, M.4    Luthy, R.5
  • 44
    • 0033012939 scopus 로고    scopus 로고
    • Oral bioequivalence of three ciprofloxacin formulations following single-dose administration: 500mg tablet compared with 500mg/10mL or 500mg/5mL suspension and the effect of food on the absorption of ciprofloxacin oral suspension
    • Shah A, Liu MC, Vaughan D, Heller AH. 1999. Oral bioequivalence of three ciprofloxacin formulations following single-dose administration: 500mg tablet compared with 500mg/10mL or 500mg/5mL suspension and the effect of food on the absorption of ciprofloxacin oral suspension. J Antimicrob Chemother 43: 49-54.
    • (1999) J Antimicrob Chemother , vol.43 , pp. 49-54
    • Shah, A.1    Liu, M.C.2    Vaughan, D.3    Heller, A.H.4
  • 45
    • 0036202184 scopus 로고    scopus 로고
    • Lack of bioequivalence of ciprofloxacin when administered with calcium-fortified orange juice: A new twist on an old interaction
    • Neuhofel AL, Wilton JH, Victory JM, Hejmanowsk LG, Amsden GW. 2002. Lack of bioequivalence of ciprofloxacin when administered with calcium-fortified orange juice: A new twist on an old interaction. J Clin Pharmacol 42: 461-466.
    • (2002) J Clin Pharmacol , vol.42 , pp. 461-466
    • Neuhofel, A.L.1    Wilton, J.H.2    Victory, J.M.3    Hejmanowsk, L.G.4    Amsden, G.W.5
  • 46
    • 0036073540 scopus 로고    scopus 로고
    • Food-drug interactions
    • Schmidt LE, Dalhoff K. 2002. Food-drug interactions. Drugs 62: 1481-1502.
    • (2002) Drugs , vol.62 , pp. 1481-1502
    • Schmidt, L.E.1    Dalhoff, K.2
  • 47
    • 0024447995 scopus 로고
    • Effect of ferrous sulfate and multivitamins with zinc on absorption of ciprofloxacin in normal volunteers
    • Polk RE, Healy DP, Sahai J, Drwal L, Racht E. 1989. Effect of ferrous sulfate and multivitamins with zinc on absorption of ciprofloxacin in normal volunteers. Antimicrob Agents Chemother 33: 1841-1844.
    • (1989) Antimicrob Agents Chemother , vol.33 , pp. 1841-1844
    • Polk, R.E.1    Healy, D.P.2    Sahai, J.3    Drwal, L.4    Racht, E.5
  • 48
    • 0027460534 scopus 로고
    • Drug-drug interactions with fluoroquinolones
    • Marchbanks CR. 1993. Drug-drug interactions with fluoroquinolones. Pharmacotherapy 13: 23S-28S.
    • (1993) Pharmacotherapy , vol.13
    • Marchbanks, C.R.1
  • 49
    • 0026334505 scopus 로고
    • Drug interactions with fluoroquinolones
    • Stein GE. 1991. Drug interactions with fluoroquinolones. Am J Med 91: 81S-86S.
    • (1991) Am J Med , vol.91
    • Stein, G.E.1
  • 50
    • 34247142812 scopus 로고    scopus 로고
    • Influence of metal cations on the solubility of fluoroquinolones
    • Zakelj S, Berginc K, Ursic D, Kristl A. 2007. Influence of metal cations on the solubility of fluoroquinolones. Pharmazie 62: 318-320.
    • (2007) Pharmazie , vol.62 , pp. 318-320
    • Zakelj, S.1    Berginc, K.2    Ursic, D.3    Kristl, A.4
  • 51
    • 11844273880 scopus 로고    scopus 로고
    • Serum and gingival crevicular fluid levels of ciprofloxacin in patients with periodontitis
    • Tözüm TF, Yildirim A, Çaglayan F, Dinçel A, Jada AB. 2004. Serum and gingival crevicular fluid levels of ciprofloxacin in patients with periodontitis. J Am Dent Assoc 135: 1728-1732.
    • (2004) J Am Dent Assoc , vol.135 , pp. 1728-1732
    • Tözüm, T.F.1    Yildirim, A.2    Çaglayan, F.3    Dinçel, A.4    Jada, A.B.5
  • 53
    • 0021971849 scopus 로고
    • Ciprofloxacin distribution in prostatic tissue and fluid following oral administration
    • Boerema JB, Dalhoff A, Debruyne FM. 1985. Ciprofloxacin distribution in prostatic tissue and fluid following oral administration. Chemotherapy 31: 13-18.
    • (1985) Chemotherapy , vol.31 , pp. 13-18
    • Boerema, J.B.1    Dalhoff, A.2    Debruyne, F.M.3
  • 56
    • 0003961244 scopus 로고
    • Quinolone antimicrobial agents
    • Hooper DC, Wolfson JS, editors., 2nd edition., Washington, DC, American Society for Microbiology.
    • Karabalut N, Drusano GL. 1993. Pharmacokinetics of the quinolone antimicrobial agents. In: Hooper DC, Wolfson JS, editors. Quinolone antimicrobial agents, 2nd edition. Washington, DC: American Society for Microbiology. 195-223.
    • (1993) Pharmacokinetics of the quinolone antimicrobial agents , pp. 195-223
    • Karabalut, N.1    Drusano, G.L.2
  • 58
    • 0023232424 scopus 로고
    • Effect of dose on serum pharmacokinetics of intravenous ciprofloxacin with identification and characterization of extravascular compartments using noncompartmental and compartmental pharmacokinetic models
    • Dudley MN, Ericson J, Zinner SH. 1987. Effect of dose on serum pharmacokinetics of intravenous ciprofloxacin with identification and characterization of extravascular compartments using noncompartmental and compartmental pharmacokinetic models. Antimicrob Agents Chemother 31: 1782-1786.
    • (1987) Antimicrob Agents Chemother , vol.31 , pp. 1782-1786
    • Dudley, M.N.1    Ericson, J.2    Zinner, S.H.3
  • 59
    • 0025309060 scopus 로고
    • Ciprofloxacin absorption in different regions of the human gastrointestinal tract. Investigations with the HF-capsule
    • Harder S, Fuhr U, Beermann D, Staib H. 1990. Ciprofloxacin absorption in different regions of the human gastrointestinal tract. Investigations with the HF-capsule. Br J Clin Pharmacol 30: 35-39.
    • (1990) Br J Clin Pharmacol , vol.30 , pp. 35-39
    • Harder, S.1    Fuhr, U.2    Beermann, D.3    Staib, H.4
  • 60
    • 19944388360 scopus 로고    scopus 로고
    • Permeability classification of representative fluoroquinolones by a cell culture method
    • Volpe DA. 2004. Permeability classification of representative fluoroquinolones by a cell culture method. AAPS Pharm Sci 6: e13.
    • (2004) AAPS Pharm Sci , vol.6
    • Volpe, D.A.1
  • 62
    • 33645314628 scopus 로고    scopus 로고
    • Ciprofloxacin permeability and its active secretion through rat small intestine in vitro
    • Žakelj S, Šturm K, Kristl A. 2006. Ciprofloxacin permeability and its active secretion through rat small intestine in vitro. Int J Pharm 313: 175-180.
    • (2006) Int J Pharm , vol.313 , pp. 175-180
    • Žakelj, S.1    Šturm, K.2    Kristl, A.3
  • 64
    • 0032775326 scopus 로고    scopus 로고
    • Active intestinal elimination of ciprofloxacin in rats: Modulation by different substrates
    • Dautrey S, Felice K, Petiet A, Lacour B, Carbon C, Farinotti R. 1999. Active intestinal elimination of ciprofloxacin in rats: Modulation by different substrates. Br J Pharmacol 127: 1728-1734.
    • (1999) Br J Pharmacol , vol.127 , pp. 1728-1734
    • Dautrey, S.1    Felice, K.2    Petiet, A.3    Lacour, B.4    Carbon, C.5    Farinotti, R.6
  • 65
    • 0034467860 scopus 로고    scopus 로고
    • Influence of passive permeability on apparent P-glycoprotein kinetics
    • Lentz KA, Polli JW, Wring SA, Humphreys JE, Polli JE. 2000. Influence of passive permeability on apparent P-glycoprotein kinetics. Pharm Res 17: 1456-1460.
    • (2000) Pharm Res , vol.17 , pp. 1456-1460
    • Lentz, K.A.1    Polli, J.W.2    Wring, S.A.3    Humphreys, J.E.4    Polli, J.E.5
  • 66
    • 0032885452 scopus 로고    scopus 로고
    • Role of P-glycoprotein-mediated secretion in absorptive drug permeability: An approach using passive membrane permeability and affinity to P-glycoprotein
    • Doppenschmitt S, Spahn-Langguth H, Regardh CG, Langguth P. 1999. Role of P-glycoprotein-mediated secretion in absorptive drug permeability: An approach using passive membrane permeability and affinity to P-glycoprotein. J Pharm Sci 88: 1067-1072.
    • (1999) J Pharm Sci , vol.88 , pp. 1067-1072
    • Doppenschmitt, S.1    Spahn-Langguth, H.2    Regardh, C.G.3    Langguth, P.4
  • 67
    • 34447513141 scopus 로고    scopus 로고
    • Bioequivalence and pharmacokinetic study of two oral formulations of ciprofloxacin tablets in healthy male volunteers
    • Azad MAK, Ullah A, Mahbub Latif AHM, Hasnat A. 2007. Bioequivalence and pharmacokinetic study of two oral formulations of ciprofloxacin tablets in healthy male volunteers. J Appl Res 7: 150-157.
    • (2007) J Appl Res , vol.7 , pp. 150-157
    • Azad, M.A.K.1    Ullah, A.2    Mahbub Latif, A.H.M.3    Hasnat, A.4
  • 69
    • 34250190274 scopus 로고    scopus 로고
    • Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers
    • Harahap Y, Prasaja B, Indriati E, Lusthom W, Lipin 2007. Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers. Int J Clin Pharmacol Ther 45: 373-376.
    • (2007) Int J Clin Pharmacol Ther , vol.45 , pp. 373-376
    • Harahap, Y.1    Prasaja, B.2    Indriati, E.3    Lusthom, W.4    Lipin5
  • 71
  • 72
    • 55249088378 scopus 로고    scopus 로고
    • Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC
    • Khan MK, Khan MF. 2008. Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC. Pak J Pharm Sci 21: 299-306.
    • (2008) Pak J Pharm Sci , vol.21 , pp. 299-306
    • Khan, M.K.1    Khan, M.F.2
  • 75
    • 85031270737 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Evaluation and Research (CDER) 2000. Guidances for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. .
    • US Department of Health and Human Services, Food and Drug Administration, Center for Evaluation and Research (CDER) 2000. Guidances for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. .
  • 76
    • 85031264812 scopus 로고    scopus 로고
    • WHO., Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability, Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceutical preparations. .
    • WHO. 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability, Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceutical preparations. .
    • (2006)
  • 77
    • 78650071604 scopus 로고    scopus 로고
    • European Medicines Evaluation Agency (EMEA), Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on the Investigation of Bioavailability and Bioequivalence. .
    • European Medicines Evaluation Agency (EMEA), 2001. Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on the Investigation of Bioavailability and Bioequivalence. .
    • (2001)
  • 78
    • 0031747422 scopus 로고    scopus 로고
    • Statistical evaluation of in vitro dissolution of different brands of ciprofloxacin hydrochloride tablets and capsules
    • Tang Y, Gan K. 1998. Statistical evaluation of in vitro dissolution of different brands of ciprofloxacin hydrochloride tablets and capsules. Drug Dev Ind Pharm 24: 549-552.
    • (1998) Drug Dev Ind Pharm , vol.24 , pp. 549-552
    • Tang, Y.1    Gan, K.2
  • 79
    • 62749183611 scopus 로고    scopus 로고
    • Solubility behavior and biopharmaceutical classification of novel high-solubility ciprofloxacin and norfloxacin pharmaceutical derivatives
    • Breda SA, Jimenez Kairuz AF, Manzo RH, Olivera ME. 2009. Solubility behavior and biopharmaceutical classification of novel high-solubility ciprofloxacin and norfloxacin pharmaceutical derivatives. Int J Pharm 371: 106-113.
    • (2009) Int J Pharm , vol.371 , pp. 106-113
    • Breda, S.A.1    Jimenez Kairuz, A.F.2    Manzo, R.H.3    Olivera, M.E.4
  • 80
    • 0016422844 scopus 로고
    • The concept of dissolution efficiency
    • Khan KA. 1975. The concept of dissolution efficiency. J Pharm Pharmacol 27: 48-49.
    • (1975) J Pharm Pharmacol , vol.27 , pp. 48-49
    • Khan, K.A.1
  • 81
    • 0034792607 scopus 로고    scopus 로고
    • Prediction of in vivo bioavailability of six brands of ciprofloxacin film coated tablets using the concept dissolution efficiency (DE)
    • Ofoefule SI, Udeogaranya PO, Okonta JM. 2001. Prediction of in vivo bioavailability of six brands of ciprofloxacin film coated tablets using the concept dissolution efficiency (DE). Boll Chim Farm 140: 187-191.
    • (2001) Boll Chim Farm , vol.140 , pp. 187-191
    • Ofoefule, S.I.1    Udeogaranya, P.O.2    Okonta, J.M.3
  • 82
    • 1842866433 scopus 로고    scopus 로고
    • An empirical assessment of the possibility of interchangeability between multisource ciprofloxacin hydrochloride tablets marketed in Nigeria
    • Osadebe PO, Esimone OC, Akabogu IC. 2003. An empirical assessment of the possibility of interchangeability between multisource ciprofloxacin hydrochloride tablets marketed in Nigeria. Boll Chim Farm 142: 352-356.
    • (2003) Boll Chim Farm , vol.142 , pp. 352-356
    • Osadebe, P.O.1    Esimone, O.C.2    Akabogu, I.C.3
  • 83
    • 85031246581 scopus 로고    scopus 로고
    • EMEA., Draft Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev.1. .
    • EMEA. 2008. Draft Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev.1. .
    • (2008)
  • 85
    • 0035286778 scopus 로고    scopus 로고
    • Caco-2 monolayers in experimental and theoretical predictions of drug transport
    • Artursson P, Palm K, Luthaman K. 2001. Caco-2 monolayers in experimental and theoretical predictions of drug transport. Adv Drug Deliv Rev 46: 27-43.
    • (2001) Adv Drug Deliv Rev , vol.46 , pp. 27-43
    • Artursson, P.1    Palm, K.2    Luthaman, K.3
  • 86
    • 0348107338 scopus 로고    scopus 로고
    • Quantitative biopharmaceutics classification system: The central role of dose/solubility ratio
    • Rinaki E, Valsami G, Macheras P. 2003. Quantitative biopharmaceutics classification system: The central role of dose/solubility ratio. Pharm Res 20: 1917-1925.
    • (2003) Pharm Res , vol.20 , pp. 1917-1925
    • Rinaki, E.1    Valsami, G.2    Macheras, P.3
  • 87
    • 0031780682 scopus 로고    scopus 로고
    • Correlation between oral drug absorption in humans and apparent drug permeability in TC-7 cells, a human epithelial intestinal cell line: Comparison with the parental Caco-2 cell line
    • Gres M-C, Julian B, Bourre M, Meunier V, Roques C, Berger M, Boulenc X, Berger Y, Fabre G. 1998. Correlation between oral drug absorption in humans and apparent drug permeability in TC-7 cells, a human epithelial intestinal cell line: Comparison with the parental Caco-2 cell line. Pharm Res 15: 726-733.
    • (1998) Pharm Res , vol.15 , pp. 726-733
    • Gres, M.1    Julian, B.2    Bourre, M.3    Meunier, V.4    Roques, C.5    Berger, M.6    Boulenc, X.7    Berger, Y.8    Fabre, G.9
  • 88
    • 3843097202 scopus 로고    scopus 로고
    • Classifi{ligature}cation of orally administered drugs on the World Health Organization Model list of essential medicines according to the biopharmaceutics classifi{ligature}cation system
    • Lindenberg M, Kopp S, Dressman JB. 2004. Classifi{ligature}cation of orally administered drugs on the World Health Organization Model list of essential medicines according to the biopharmaceutics classifi{ligature}cation system. Eur J Pharm Biopharm 58: 265-278.
    • (2004) Eur J Pharm Biopharm , vol.58 , pp. 265-278
    • Lindenberg, M.1    Kopp, S.2    Dressman, J.B.3
  • 89
    • 17644380257 scopus 로고    scopus 로고
    • Predicting drug disposition via application of BCS: Transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system
    • Wu CY, Benet LZ. 2005. Predicting drug disposition via application of BCS: Transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res 22: 11-23.
    • (2005) Pharm Res , vol.22 , pp. 11-23
    • Wu, C.Y.1    Benet, L.Z.2
  • 90
    • 85031262450 scopus 로고    scopus 로고
    • WHO., Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert committee on specifications. .
    • WHO. 2006. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No 937, 40th Report, Annex 8 of WHO Expert committee on specifications. .
    • (2006)
  • 91
    • 85031260702 scopus 로고    scopus 로고
    • BioINequivalence: Concept and Definition. ACPS Meeting, October 19-20. (accessed 10-25-2009).
    • Yu LX. 2004. BioINequivalence: Concept and Definition. ACPS Meeting, October 19-20. (accessed 10-25-2009).
    • (2004)
    • Yu, L.X.1
  • 93
    • 85031271327 scopus 로고    scopus 로고
    • FDA., Guidance for Industry. Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR) .
    • FDA. 2005. Guidance for Industry. Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR) .
    • (2005)
  • 94
    • 78650074512 scopus 로고    scopus 로고
    • European Commission., Guideline on Dossier requirements for Type IA and Type IB. .
    • European Commission. 2006. Guideline on Dossier requirements for Type IA and Type IB. .
    • (2006)


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