Tras la puesta en circulación de un fármaco es la fase que permite estudiar sus efectos y tolerancia a largo plazo.

   <(F.): Essai de phase IV: (succédant à la mise sur le marché) permettent d’étudier les effets et la tolérance à long terme.

    <(In.): Phase IV of clinical trial: concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing  studies to delineate additional information about the drug’s risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.

   TERMINOS RELACIONADOS:

• ENSAYO CLINICO EN FASE III
• ENSAYO CLINICO A DOBLE CIEGO.
• ENSAYO CLINICO CIEGO
• ENSAYO CLINICO EN FASE I.
• ENSAYO CLINICO EN FASE II
• FASES DE LOS ENSAYOS CLINICOS.