Hollow Fiber System Model for Tuberculosis: The European Medicines Agency Experience

被引:33
作者
Cavaleri, Marco [1 ]
Manolis, Efthymios [2 ]
机构
[1] European Med Agcy, Human Med Evaluat Div, Antiinfect & Vaccines, London, England
[2] European Med Agcy, Human Med Res & Dev Support Div Sci Advice, London, England
关键词
tuberculosis; PK/PD; in vitro models; EMA; qualification;
D O I
10.1093/cid/civ484
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
The in vitro hollow fiber system model has been qualified by the European Medicines Agency as a methodology for use in support of selection and development of antituberculosis regimens. More data are expected to be generated in the future to further characterize its value.
引用
收藏
页码:S1 / S4
页数:4
相关论文
共 12 条
[1]   2 COMPARTMENT KINETIC-MODEL WITH MULTIPLE ARTIFICIAL CAPILLARY UNITS [J].
BLASER, J ;
STONE, BB ;
ZINNER, SH .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 1985, 15 :131-137
[2]   Analysis of Combination Drug Therapy to Develop Regimens with Shortened Duration of Treatment for Tuberculosis [J].
Drusano, George L. ;
Neely, Michael ;
Van Guilder, Michael ;
Schumitzky, Alan ;
Brown, David ;
Fikes, Steven ;
Peloquin, Charles ;
Louie, Arnold .
PLOS ONE, 2014, 9 (07)
[3]  
European Medicines Agency, 2015, ROAD MAP
[4]  
European Medicines Agency, DRAFT CONCEPT PAPER
[5]  
European Medicines Agency, FIN QUAL OP
[6]  
European Medicines Agency, CONC PAP REV ADD NOT
[7]  
European Medicines Agency, NOV METH WEBP
[8]   Forecasting Accuracy of the Hollow Fiber Model of Tuberculosis for Clinical Therapeutic Outcomes [J].
Gumbo, Tawanda ;
Pasipanodya, Jotam G. ;
Romero, Klaus ;
Hanna, Debra ;
Nuermberger, Eric .
CLINICAL INFECTIOUS DISEASES, 2015, 61 :S25-S31
[9]   Correlations Between the Hollow Fiber Model of Tuberculosis and Therapeutic Events in Tuberculosis Patients: Learn and Confirm [J].
Gumbo, Tawanda ;
Pasipanodya, Jotam G. ;
Nuermberger, Eric ;
Romero, Klaus ;
Hanna, Debra .
CLINICAL INFECTIOUS DISEASES, 2015, 61 :S18-S24
[10]  
Manolis E, 2015, METHODS MOL BIOL, V1243, P255, DOI 10.1007/978-1-4939-1872-0_15