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Conferencia Transatlántica sobre directrices de ensayos clínicos en la enfermedad arterial periférica: metodología de
K H Labs1, J A Dormandy, K A Jaeger
1Department of Angiology, University of Basel Medical School, Basel, Switzerland.
Circulation
|October 27, 1999
Resumen
La cooperación transatlántica en el desarrollo de fármacos para la enfermedad arterial periférica (EAP) es crucial. Este resumen presenta las principales conclusiones de una conferencia de Basilea de 1997, con el objetivo de orientar las futuras directrices transatlánticas para la evaluación de la farmacoterapia PAD.
Área de la Ciencia:
- Farmacología Farmacología.
- Investigación clínica La investigación clínica es la investigación clínica.
- Ciencias de la Regulación Ciencias de la Regulación
Sus antecedentes:
- Las directrices de desarrollo de fármacos existentes para la enfermedad arterial periférica (EAP) de la FDA de los Estados Unidos y los organismos reguladores de la UE requieren una armonización transatlántica.
- La globalización subraya la necesidad de enfoques unificados en la investigación y el desarrollo farmacéutico.
- Una conferencia de Basilea de 1997 convocó a expertos para discutir las pruebas científicas que sustentan las directrices actuales de PAD.
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