EMA; In vitro models; PK PD; Qualification; Tuberculosis
Indexed keywords
TUBERCULOSTATIC AGENT;
ARTICLE;
EUROPEAN MEDICINES AGENCY;
FOOD AND DRUG ADMINISTRATION;
HOLLOW FIBER;
HUMAN;
IN VITRO STUDY;
METHODOLOGY;
MONTE CARLO METHOD;
PERSONAL EXPERIENCE;
PRIORITY JOURNAL;
RISK ASSESSMENT;
TUBERCULOSIS;
BIOLOGICAL MODEL;
DRUG DEVELOPMENT;
DRUG EFFECTS;
MICROBIOLOGY;
MYCOBACTERIUM TUBERCULOSIS;
PRECLINICAL STUDY;
PROCEDURES;
ANTITUBERCULAR AGENTS;
DRUG DISCOVERY;
DRUG EVALUATION, PRECLINICAL;
HUMANS;
IN VITRO TECHNIQUES;
MODELS, BIOLOGICAL;
MYCOBACTERIUM TUBERCULOSIS;
TUBERCULOSIS;
Systematic analysis of hollow fiber model of tuberculosis experiments
Pasipanodya J, Nuermberger E, Romer K, Hanna D, Gumbo T. Systematic analysis of hollow fiber model of tuberculosis experiments. Clin Infect Dis 2015; 61(suppl 1):S10-7.
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.
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.
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.
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.
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.
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.
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.
European Medicines Agency. Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline. Available at: http://www.ema.europa.eu/ema/doc-index.jsp?curl=pages/includes/document/document-detail.jsp?webContentId=WC500162135&murl=menus/document-library/document-library.jsp&mid=0b01ac058009a3dc. 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.
European Medicines Agency. Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/11/WC500177902.pdf. Accessed 30 June 2015.