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

Clin Infect Dis. 2015 Aug 15;61 Suppl 1:S1-4. doi: 10.1093/cid/civ484.

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.

Keywords: EMA; PK/PD; in vitro models; qualification; tuberculosis.

MeSH terms

  • Antitubercular Agents / pharmacokinetics*
  • Antitubercular Agents / pharmacology*
  • Drug Discovery / methods*
  • Drug Evaluation, Preclinical*
  • Humans
  • In Vitro Techniques
  • Models, Biological
  • Mycobacterium tuberculosis / drug effects*
  • Tuberculosis / drug therapy*
  • Tuberculosis / microbiology

Substances

  • Antitubercular Agents