RESUMEN

Nonclinical studies are fundamental for the development of inhaled drugs, as for any drug product, and for successful translation to clinical practice. They include in silico, in vitro, ex vivo and in vivo studies and are intended to provide a comprehensive understanding of the inhaled drug beneficial and detrimental effects. To date, animal models cannot be circumvented during drug development programs, acting as surrogates of humans to predict inhaled drug response, fate and toxicity. Herein, we review the animal models used during the different development stages of inhaled pharmaceuticals and biopharmaceuticals, highlighting their strengths and limitations.

Asunto(s)

Aerosoles/administración & dosificación , Aerosoles/farmacología , Productos Biológicos/administración & dosificación , Productos Biológicos/farmacología , Modelos Animales , Administración por Inhalación , Aerosoles/farmacocinética , Animales , Productos Biológicos/farmacocinética , Evaluación Preclínica de Medicamentos/métodos , Humanos , Orofaringe/metabolismo , Preparaciones Farmacéuticas/administración & dosificación , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Roedores , Estados Unidos , United States Food and Drug Administration