All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (from US FDA ‘Guideline for Industry, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting’).
Toda respuesta nociva y no deseada a un producto medicinal, relacionada con cualquier dosis, se debe considerar una reacción medicamentosa adversa (del Lineamiento para la Industria, Manejo de Datos de Seguridad Clínica: Definiciones y Normas para la Comunicación Expedita, de la FDA de EE.UU.)
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (from US FDA Guideline for Industry, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).