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Este proceso implica la evaluacin concienzuda de los datos de seguridad y eficacia del producto, entre los cuales se incluyen estudios de estabilidad, validacin de mtodos analticos, verificacin de la calidad, Certificado de Buenas Prcticas de Manufactura, estudios de seguridad y eficacia, entre otros, sealan al respecto investigadores del Centro Nacional de Informacin de Medicamentos de la Universidad de Costa Rica (CIMED-UCR)
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