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Volumn 61, Issue , 2015, Pages S1-S4

Hollow fiber system model for tuberculosis: The European Medicines Agency experience

Author keywords

EMA; In vitro models; PK PD; Qualification; Tuberculosis

Indexed keywords

TUBERCULOSTATIC AGENT;

EID: 84942121678     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ484     Document Type: Article
Times cited : (35)

References (12)
  • 2
    • 84903888878 scopus 로고    scopus 로고
    • Analysis of combination drug therapy to develop regimens with shortened duration of treatment for tuberculosis
    • Drusano GL, Neely M, Van Guilder M, et al. Analysis of combination drug therapy to develop regimens with shortened duration of treatment for tuberculosis. PLoS One 2014; 9:e101311.
    • (2014) PLoS One , vol.9
    • Drusano, G.L.1    Neely, M.2    Van Guilder, M.3
  • 3
    • 84942083672 scopus 로고    scopus 로고
    • Strategic regulatory evaluation and endorsement of the hollow fiber tuberculosis system as a novel drug development tool
    • Romero K, Clay R, Hanna D. Strategic regulatory evaluation and endorsement of the hollow fiber tuberculosis system as a novel drug development tool. Clin Infect Dis 2015; 61(suppl 1):S5-9.
    • (2015) Clin Infect Dis , vol.61 , pp. S5-S9
    • Romero, K.1    Clay, R.2    Hanna, D.3
  • 4
    • 84870451269 scopus 로고    scopus 로고
    • Available at: Accessed 30 June 2015
    • European Medicines Agency. Road map to 2015. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Report/2011/01/WC500101373.pdf. Accessed 30 June 2015.
    • Road Map to 2015
  • 5
    • 84942158821 scopus 로고    scopus 로고
    • Available at Accessed 30 June 2015
    • European Medicines Agency. Novel methodologies webpage. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document-listing/document-listing-000319.jsp&mid=WC0b01ac0580022bb0. Accessed 30 June 2015.
    • Novel Methodologies Webpage
  • 6
    • 84921720750 scopus 로고    scopus 로고
    • The European Medicines Agency experience with biomarker qualification clinical proteomics
    • Manolis E, Koch A, Deforce D, Vamvakas S. The European Medicines Agency experience with biomarker qualification clinical proteomics. Methods Mol Biol 2015; 1243:255-72.
    • (2015) Methods Mol Biol , vol.1243 , pp. 255-272
    • Manolis, E.1    Koch, A.2    Deforce, D.3    Vamvakas, S.4
  • 7
    • 0021809096 scopus 로고
    • Two compartment kinetic model with multiple artificial capillary units
    • Blaser J, Stone BB, Zinner SH. Two compartment kinetic model with multiple artificial capillary units. J Antimicrob Chemother 1985; 15(suppl A):131-7.
    • (1985) J Antimicrob Chemother , vol.15 , pp. 131-137
    • Blaser, J.1    Stone, B.B.2    Zinner, S.H.3
  • 8
    • 84942111105 scopus 로고    scopus 로고
    • Correlations between the hollow fiber model of tuberculosis and therapeutic events in tuberculosis patients: Learn and confirm
    • Gumbo T, Pasipanodya JG, Nuermberger E, Romero K, Hanna D. Correlations between the hollow fiber model of tuberculosis and therapeutic events in tuberculosis patients: learn and confirm. Clin Infect Dis 2015; 61(suppl 1):S18-24.
    • (2015) Clin Infect Dis , vol.61 , pp. S18-S24
    • Gumbo, T.1    Pasipanodya, J.G.2    Nuermberger, E.3    Romero, K.4    Hanna, D.5
  • 9
    • 84942084425 scopus 로고    scopus 로고
    • Forecasting accuracy of the hollow fiber system model of tuberculosis for clinical therapeutic outcomes
    • Gumbo T, Pasipanodya JG, Nuermberger E, Romero K, Hanna D. Forecasting accuracy of the hollow fiber system model of tuberculosis for clinical therapeutic outcomes. Clin Infect Dis 2015; 61(suppl 1):S25-31.
    • (2015) Clin Infect Dis , vol.61 , pp. S25-S31
    • Gumbo, T.1    Pasipanodya, J.G.2    Nuermberger, E.3    Romero, K.4    Hanna, D.5
  • 11
    • 84942158823 scopus 로고    scopus 로고
    • Available at: Accessed 30 June 2015
    • European Medicines Agency. Final qualification opinion. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2015/02/WC500181899.pdf. Accessed 30 June 2015.
    • Final Qualification Opinion


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.