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Animal models for Francisella tularensis and Burkholderia species: scientific and regulatory gaps toward approval of antibiotics under the FDA Animal Rule.

Stundick, M V; Albrecht, M T; Houchens, C R; Smith, A Pierce; Dreier, T M; Larsen, J C.

Vet Pathol ; 50(5): 877-92, 2013 Sep.

Artículo en Inglés | MEDLINE | ID: mdl-23628693

RESUMEN

The development and regulatory approval of medical countermeasures (MCMs) for the treatment and prevention of bacterial threat agent infections will require the evaluation of products in animal models. To obtain regulatory approval, these models must accurately recapitulate aspects of human disease, including, but not necessarily limited to, route of exposure, time to disease onset, pathology, immune response, and mortality. This article focuses on the state of animal model development for 3 agents for which models are largely immature: Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei. An overview of available models and a description of scientific and regulatory gaps are provided.

Asunto(s)

Antibacterianos/farmacología , Infecciones por Burkholderia/tratamiento farmacológico , Burkholderia/efectos de los fármacos , Modelos Animales de Enfermedad , Aprobación de Drogas/métodos , Francisella tularensis/efectos de los fármacos , Tularemia/tratamiento farmacológico , Animales , Ciprofloxacina , Aprobación de Drogas/legislación & jurisprudencia , Regulación Gubernamental , Levofloxacino , Estados Unidos , United States Food and Drug Administration

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