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Volumn 43, Issue 1, 2014, Pages 1-6

Multicomponent antibiotic substances produced by fermentation: Implications for regulatory authorities, critically ill patients and generics

Author keywords

Colistin; Generic; ICU; Pharmacokinetics; Subcomponent

Indexed keywords

COLISTIMETHATE; COLISTIN; COLISTIN A; GENERIC DRUG; POLYMYXIN E2; TEICOPLANIN; TEICOPLANIN A2-1; TEICOPLANIN A2-2; TEICOPLANIN A2-3; TEICOPLANIN A2-4; TEICOPLANIN A2-5; UNCLASSIFIED DRUG; VANCOMYCIN;

EID: 84890792786     PISSN: 09248579     EISSN: 18727913     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2013.06.013     Document Type: Note
Times cited : (42)

References (34)
  • 1
    • 80054090960 scopus 로고    scopus 로고
    • Actinoplanes teichomyceticus ATCC 31121 as a cell factory for producing teicoplanin
    • C. Taurino, L. Frattini, G.L. Marcone, and F. Marinelli Actinoplanes teichomyceticus ATCC 31121 as a cell factory for producing teicoplanin Microbiol Cell Fact 10 2011 82 95
    • (2011) Microbiol Cell Fact , vol.10 , pp. 82-95
    • Taurino, C.1    Frattini, L.2    Marcone, G.L.3    Marinelli, F.4
  • 2
    • 0026019412 scopus 로고
    • Factors affecting the normal and branched-chain acyl moieties of teicoplanin components produced by Actinoplanes teichomyceticus
    • A. Borghi, E. Duncan, L.F. Zerilli, and G.C. Lancini Factors affecting the normal and branched-chain acyl moieties of teicoplanin components produced by Actinoplanes teichomyceticus J Gen Microbiol 137 1991 587 592
    • (1991) J Gen Microbiol , vol.137 , pp. 587-592
    • Borghi, A.1    Duncan, E.2    Zerilli, L.F.3    Lancini, G.C.4
  • 3
    • 84877845927 scopus 로고    scopus 로고
    • Complex product composition generates risks for generic substitution also with dosage forms for intravenous administration
    • A. Rossi, F. Buttini, P. Colombo, M. Mor, D. Pala, and F. Bortolotti Complex product composition generates risks for generic substitution also with dosage forms for intravenous administration Int J Pharm 451 2013 50 56
    • (2013) Int J Pharm , vol.451 , pp. 50-56
    • Rossi, A.1    Buttini, F.2    Colombo, P.3    Mor, M.4    Pala, D.5    Bortolotti, F.6
  • 4
    • 0034323382 scopus 로고    scopus 로고
    • Comparative pharmacokinetics of teicoplanin and vancomycin
    • I. Harding, and F. Sorgel Comparative pharmacokinetics of teicoplanin and vancomycin J Chemother 12 2000 15 20
    • (2000) J Chemother , vol.12 , pp. 15-20
    • Harding, I.1    Sorgel, F.2
  • 5
    • 26444519133 scopus 로고    scopus 로고
    • Improved quantitative determination of total and unbound concentrations of six teicoplanin components in human plasma by high performance liquid chromatography
    • K. Hanada, A. Kobayashi, Y. Okamori, T. Kimura, and H. Ogata Improved quantitative determination of total and unbound concentrations of six teicoplanin components in human plasma by high performance liquid chromatography Biol Pharm Bull 28 2005 2023 2025
    • (2005) Biol Pharm Bull , vol.28 , pp. 2023-2025
    • Hanada, K.1    Kobayashi, A.2    Okamori, Y.3    Kimura, T.4    Ogata, H.5
  • 7
    • 34248156161 scopus 로고    scopus 로고
    • Comparison of pharmacokinetics of individual teicoplanin components in patients
    • K. Hanada, S. Ikari, Y. Koukaki, A. Utena, T. Kimura, and K. Hamano Comparison of pharmacokinetics of individual teicoplanin components in patients Biol Pharm Bull 30 2007 952 954
    • (2007) Biol Pharm Bull , vol.30 , pp. 952-954
    • Hanada, K.1    Ikari, S.2    Koukaki, Y.3    Utena, A.4    Kimura, T.5    Hamano, K.6
  • 10
    • 78751558968 scopus 로고    scopus 로고
    • The effect of hypoalbuminaemia on optimizing antibacterial dosing in critically ill patients
    • M. Ulldemolins, J.A. Roberts, J. Rello, D.L. Paterson, and J. Lipman The effect of hypoalbuminaemia on optimizing antibacterial dosing in critically ill patients Clin Pharmacokinet 50 2011 99 110
    • (2011) Clin Pharmacokinet , vol.50 , pp. 99-110
    • Ulldemolins, M.1    Roberts, J.A.2    Rello, J.3    Paterson, D.L.4    Lipman, J.5
  • 11
    • 34547676201 scopus 로고    scopus 로고
    • Variability in teicoplanin protein binding and its prediction using serum albumin concentrations
    • R. Yano, T. Nakamura, H. Tsukamoto, T. Igarashi, N. Goto, and Y. Wakiya Variability in teicoplanin protein binding and its prediction using serum albumin concentrations Ther Drug Monit 29 2007 399 403
    • (2007) Ther Drug Monit , vol.29 , pp. 399-403
    • Yano, R.1    Nakamura, T.2    Tsukamoto, H.3    Igarashi, T.4    Goto, N.5    Wakiya, Y.6
  • 12
    • 53249113145 scopus 로고    scopus 로고
    • Recommendations to achieve rapid therapeutic teicoplanin plasma concentrations in adult hospitalized patients treated for sepsis
    • A.J. Brink, G.A. Richards, R.R. Cummins, and J. Lambson Recommendations to achieve rapid therapeutic teicoplanin plasma concentrations in adult hospitalized patients treated for sepsis Int J Antimicrob Agents 32 2008 455 458
    • (2008) Int J Antimicrob Agents , vol.32 , pp. 455-458
    • Brink, A.J.1    Richards, G.A.2    Cummins, R.R.3    Lambson, J.4
  • 13
    • 0021243216 scopus 로고
    • Teichomycins, new antibiotics from Actinoplanes teichomyceticus nov. Sp. IV. Separation and characterization of the components of teichomycin (teicoplanin)
    • A. Borghi, C. Coronelli, L. Faniuolo, G. Allieve, R. Pallanza, and G.G. Gallo Teichomycins, new antibiotics from Actinoplanes teichomyceticus nov. sp. IV. Separation and characterization of the components of teichomycin (teicoplanin) J Antibiot (Tokyo) 6 1984 615 620
    • (1984) J Antibiot (Tokyo) , vol.6 , pp. 615-620
    • Borghi, A.1    Coronelli, C.2    Faniuolo, L.3    Allieve, G.4    Pallanza, R.5    Gallo, G.G.6
  • 14
    • 84890800701 scopus 로고    scopus 로고
    • European Patent Specification Bulletin 2006/52. 27 December 2006. [accessed 20.03.13]
    • European Patent Specification. A teicoplanin composition with improved antibiotic activity. Bulletin 2006/52. 27 December 2006. https://data.epo.org/ publication-server/pdf-document?pn=1516626&ki=B1&cc=EP [accessed 20.03.13].
    • A Teicoplanin Composition with Improved Antibiotic Activity
  • 15
    • 84890786107 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP) 25 June 2009. [accessed 19.02.13]
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP). Annex II. Scientific conclusions and grounds for refusal: Hospira teicoplanin. 25 June 2009. http://www.ema.europa.eu/docs/en-GB/document- library/Referrals-document/Teicoplanin-Hospira-29/WC500095134.pdf [accessed 19.02.13].
    • Annex II. Scientific Conclusions and Grounds for Refusal: Hospira Teicoplanin
  • 17
    • 84890807394 scopus 로고    scopus 로고
    • European Medicines Agency Teicoplanin. Procedure no: EMEA/H/A-5(3)/1315. EMA; 21 March 2013. [accessed 24.04.13]
    • European Medicines Agency. Assessment report. Review under Article 5(3) of Regulation (EC) No 726/2004. Teicoplanin. Procedure no: EMEA/H/A-5(3)/1315. EMA; 21 March 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Report/ 2013/04/WC500142229.pdf [accessed 24.04.13].
    • Assessment Report. Review under Article 5(3) of Regulation (EC) No 726/2004
  • 19
    • 0037378043 scopus 로고    scopus 로고
    • Stability of colistin and colistin methanesulfonate in aqueous media and plasma as determined by high-performance liquid chromatography
    • J. Li, R.W. Milne, R.L. Nation, J.D. Turnidge, and K. Coulthard Stability of colistin and colistin methanesulfonate in aqueous media and plasma as determined by high-performance liquid chromatography Antimicrob Agents Chemother 47 2003 1364 1370
    • (2003) Antimicrob Agents Chemother , vol.47 , pp. 1364-1370
    • Li, J.1    Milne, R.W.2    Nation, R.L.3    Turnidge, J.D.4    Coulthard, K.5
  • 20
    • 17644389620 scopus 로고    scopus 로고
    • Colistin: The revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections
    • M.E. Falagas, and S.K. Kasiakou Colistin: the revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections Clin Infect Dis 40 2005 1333 1341
    • (2005) Clin Infect Dis , vol.40 , pp. 1333-1341
    • Falagas, M.E.1    Kasiakou, S.K.2
  • 21
    • 84861503207 scopus 로고    scopus 로고
    • Editorial commentary: Closing the loop - A colistin clinical study to confirm dosing recommendations from PK/PD modeling
    • J.A. Roberts, and J. Lipman Editorial commentary: closing the loop - a colistin clinical study to confirm dosing recommendations from PK/PD modeling Clin Infect Dis 54 2012 1727 1729
    • (2012) Clin Infect Dis , vol.54 , pp. 1727-1729
    • Roberts, J.A.1    Lipman, J.2
  • 22
    • 0031306775 scopus 로고    scopus 로고
    • Hyphenated liquid chromatographic method for the determination of colistin residues in bovine tissues
    • D. Decolin, P. Leroy, A. Nicolas, and P. Archimbault Hyphenated liquid chromatographic method for the determination of colistin residues in bovine tissues J Chromatogr Sci 35 1997 557 564
    • (1997) J Chromatogr Sci , vol.35 , pp. 557-564
    • Decolin, D.1    Leroy, P.2    Nicolas, A.3    Archimbault, P.4
  • 23
    • 77951213978 scopus 로고    scopus 로고
    • Assay of colistin and colistin methanesulfonate in plasma and urine by liquid chromatography-tandem mass spectrometry
    • P. Gobin, F. Lemaitre, S. Marchand, W. Couet, and J-C. Oliver Assay of colistin and colistin methanesulfonate in plasma and urine by liquid chromatography-tandem mass spectrometry Antimicrob Agents Chemother 54 2010 1941 1948
    • (2010) Antimicrob Agents Chemother , vol.54 , pp. 1941-1948
    • Gobin, P.1    Lemaitre, F.2    Marchand, S.3    Couet, W.4    Oliver, J.-C.5
  • 24
    • 79959248672 scopus 로고    scopus 로고
    • Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients
    • S.M. Garonzik, J. Li, V. Thamlikitkul, D.L. Paterson, S. Shoham, and J. Jacob Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients Antimicrob Agents Chemother 55 2011 3284 3294
    • (2011) Antimicrob Agents Chemother , vol.55 , pp. 3284-3294
    • Garonzik, S.M.1    Li, J.2    Thamlikitkul, V.3    Paterson, D.L.4    Shoham, S.5    Jacob, J.6
  • 25
    • 84555190530 scopus 로고    scopus 로고
    • Paenibacillus polymyxa PKB1 produces variants of polymyxin B-type antibiotics
    • M. Shaheen, J. Li, A.C. Ross, J.C. Vederas, and S.E. Jensen Paenibacillus polymyxa PKB1 produces variants of polymyxin B-type antibiotics Chem Biol 18 2011 1640 1648
    • (2011) Chem Biol , vol.18 , pp. 1640-1648
    • Shaheen, M.1    Li, J.2    Ross, A.C.3    Vederas, J.C.4    Jensen, S.E.5
  • 28
    • 0035118424 scopus 로고    scopus 로고
    • In vitro pharmacodynamic properties of colistin and colistin methanesulfonate against Pseudomonas aeruginosa isolates from patients with cystic fibrosis
    • J. Li, J. Turnidge, R. Milne, R.L. Nation, and K. Coulthard In vitro pharmacodynamic properties of colistin and colistin methanesulfonate against Pseudomonas aeruginosa isolates from patients with cystic fibrosis Antimicrob Agents Chemother 45 2001 781 785
    • (2001) Antimicrob Agents Chemother , vol.45 , pp. 781-785
    • Li, J.1    Turnidge, J.2    Milne, R.3    Nation, R.L.4    Coulthard, K.5
  • 29
    • 78651418559 scopus 로고    scopus 로고
    • Response to: Colistin penetration in the alveolar lining fluid of critically ill patients treated with IV colistimethate sodium
    • R. Imberti, G.A. Lotti, M. Cusato, and M. Regazzi Response to: colistin penetration in the alveolar lining fluid of critically ill patients treated with IV colistimethate sodium Chest 139 2011 233 234
    • (2011) Chest , vol.139 , pp. 233-234
    • Imberti, R.1    Lotti, G.A.2    Cusato, M.3    Regazzi, M.4
  • 30
    • 35348938075 scopus 로고    scopus 로고
    • Activity of colistin against heteroresistant Acinetobacter baumannii and emergence of resistance in an in vitro pharmacokinetic/pharmacodynamic model
    • C. Tan, J. Li, and R.L. Nation Activity of colistin against heteroresistant Acinetobacter baumannii and emergence of resistance in an in vitro pharmacokinetic/pharmacodynamic model Antimicrob Agents Chemother 51 2007 3413 3415
    • (2007) Antimicrob Agents Chemother , vol.51 , pp. 3413-3415
    • Tan, C.1    Li, J.2    Nation, R.L.3
  • 31
    • 84857013566 scopus 로고    scopus 로고
    • A simple HPLC method for the separation of colistimethate sodium and colistin sulphate
    • L. Bai, Z. Ma, G. Yang, J. Yang, and J. Cheng A simple HPLC method for the separation of colistimethate sodium and colistin sulphate J Chromatogr Seperat Tech 2 2011 1 4
    • (2011) J Chromatogr Seperat Tech , vol.2 , pp. 1-4
    • Bai, L.1    Ma, Z.2    Yang, G.3    Yang, J.4    Cheng, J.5
  • 33
    • 33644952525 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP) EMEA; 30 October 2005. CHMP/437/04. [accessed 28.03.13]
    • Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. EMEA; 30 October 2005. CHMP/437/04. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003517.pdf [accessed 28.03.13].
    • Guideline on Similar Biological Medicinal Products
  • 34
    • 84890788354 scopus 로고    scopus 로고
    • French Agency for Safety of Health Products [Agence française de sécurité sanitaire des produits de santé (AFSSAPS)] AFSSAPS; March 2013. [accessed 10.04.13]
    • French Agency for Safety of Health Products [Agence française de sécurité sanitaire des produits de santé (AFSSAPS)]. Summary of 'Information on the actions of the AFSSAPS concerning generic injectable antibiotics'. AFSSAPS; March 2013. http://ansm.sante.fr/var/ansm- site/storage/original/application/18c0540392a89453c92ffc064b5b8f30.pdf [accessed 10.04.13].
    • Summary of 'Information on the Actions of the AFSSAPS Concerning Generic Injectable Antibiotics'


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