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

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

Author information

1
Human Medicines Evaluation Division-Anti-infectives and Vaccines.
2
Human Medicines Research and Development Support Division-Scientific Advice, European Medicines Agency, London, United Kingdom.

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

PMID:
26224766
DOI:
10.1093/cid/civ484
[Indexed for MEDLINE]

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