title: Hollow Fiber System Model for Tuberculosis: The European Medicines Agency Experience.
abstract: 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.
authors.affiliation: Human Medicines Evaluation Division-Anti-infectives and Vaccines.
authors.forename: Marco
authors.initials: M
authors.lastname: Cavaleri
authors.affiliation: Human Medicines Research and Development Support Division-Scientific Advice, European Medicines Agency, London, United Kingdom.
authors.forename: Efthymios
authors.initials: E
authors.lastname: Manolis
mesh_terms: D000995:Antitubercular Agents / Q000493:pharmacokinetics* / Q000494:pharmacology*; D055808:Drug Discovery / Q000379:methods*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D066298:In Vitro Techniques; D008954:Models, Biological; D009169:Mycobacterium tuberculosis / Q000187:drug effects*; D014376:Tuberculosis / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents
keywords: EMA; PK/PD; in vitro models; qualification; tuberculosis