Drug development tools; Model based drug design; Quantitative pharmacology; Regulatory science; Tuberculosis
Indexed keywords
TUBERCULOSTATIC AGENT;
NEW DRUG;
ARTICLE;
DECISION MAKING;
DRUG CONTROL;
DRUG DESIGN;
DRUG DEVELOPMENT;
DRUG DEVELOPMENT TOOL;
DRUG SURVEILLANCE PROGRAM;
MEASUREMENT ACCURACY;
MONTE CARLO METHOD;
NONHUMAN;
OUTCOME ASSESSMENT;
PREDICTIVE VALUE;
PRIORITY JOURNAL;
QUANTITATIVE ANALYSIS;
TUBERCULOSIS;
ANIMAL;
BIOLOGICAL MODEL;
DRUG APPROVAL;
DRUG INDUSTRY;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
LEGISLATION AND JURISPRUDENCE;
MICROBIOLOGY;
PROCEDURES;
STANDARDS;
UNITED STATES;
ANIMALS;
ANTITUBERCULAR AGENTS;
DRUG APPROVAL;
DRUG DISCOVERY;
DRUG INDUSTRY;
DRUGS, INVESTIGATIONAL;
HUMANS;
MODELS, BIOLOGICAL;
MONTE CARLO METHOD;
PREDICTIVE VALUE OF TESTS;
TUBERCULOSIS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Systematic analysis of hollow fiber model of tuberculosis experiments
Pasipanodya JG, Nuermberger E, Romero K, Hanna D, Gumbo T. Systematic analysis of hollow fiber model of tuberculosis experiments. Clin Infect Dis 2015; 61(suppl 1):S10-7.
Selection of a moxifloxacin dose that suppresses drug resistance in Mycobacterium tuberculosis, by use of an in vitro pharmacodynamic infection model and mathematical modeling
Gumbo T, Louie A, Deziel MR, Parsons LM, Salfinger M, Drusano GL. Selection of a moxifloxacin dose that suppresses drug resistance in Mycobacterium tuberculosis, by use of an in vitro pharmacodynamic infection model and mathematical modeling. J Infect Dis 2004; 190:1642-51.
Pharmacokinetics-pharmacodynamics of pyrazinamide in a novel in vitro model of tuberculosis for sterilizing effect: A paradigm for faster assessment of new antituberculosis drugs
Gumbo T, Dona CS, Meek C, Leff R. Pharmacokinetics-pharmacodynamics of pyrazinamide in a novel in vitro model of tuberculosis for sterilizing effect: a paradigm for faster assessment of new antituberculosis drugs. Antimicrob Agents Chemother 2009; 53:3197-204.
The combination of rifampin plus moxifloxacin is synergistic for suppression of resistance but antagonistic for cell kill of Mycobacterium tuberculosis as determined in a hollow-fiber infection model
Drusano GL, Sgambati N, Eichas A, Brown DL, Kulawy R, Louie A. The combination of rifampin plus moxifloxacin is synergistic for suppression of resistance but antagonistic for cell kill of Mycobacterium tuberculosis as determined in a hollow-fiber infection model. MBio 2010; 1:1-8.
Forecasting accuracy of the hollow fiber system model of tuberculosis for clinical therapeutic outcomes
Gumbo T, Pasipanodya JG, Romero K, Hanna D, Nuermberger E. Forecasting accuracy of the hollow fiber system model of tuberculosis for clinical therapeutic outcomes. Clin Infect Dis 2015; 61(suppl 1):S25-31.
US Food and Drug Administration. Guidance for Industry and FDA Staff. Qualification process for drug development tools. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf. Accessed 3 January 2013.
European Medicines Agency. Qualification of novel methodologies for drug development: guidance to applicants. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2009/10/WC500004201.pdf. Accessed 5 February 2013.
European Medicines Agency. Qualification of novel methodologies for medicine development. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document-listing/document-listing-000319.jsp. Accessed 5 February 2013.
US Food and Drug Administration. Voluntary Exploratory Data Submissions (VXDS). Available at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083673.htm. Accessed 27 February 2013.
European Medicines Agency. Draft qualification opinion on in vitro hollow-fibre-system model of tuberculosis (HFS-TB). Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document-detail.jsp?webContentId=WC500177457&mid=WC0b01ac058009a3dc. Accessed 26 January 2015.
European Medicines Agency. Qualification of novel methodologies for drug development: guidance to applicants. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2009/10/WC500004201.pdf. Accessed 5 February 2013.
The hollow fiber system model in the nonclinical evaluation of anti-tuberculosis drug regimens
Chilukuri D, McMaster O, Bergman K, Colangelo P, Snow K, Toerner JG. The hollow fiber system model in the nonclinical evaluation of anti-tuberculosis drug regimens. Clin Infect Dis 2015; 61(suppl 1):S31-3.
