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La FDA mantiene un proceso riguroso de aprobacin que requiere: Estudios preclnicos: Evaluacin de seguridad y farmacocintica en modelos animales Ensayos clnicos de Fase I: Seguridad y tolerabilidad en humanos sanos Ensayos clnicos de Fase II: Determinacin de dosis y eficacia preliminar Ensayos clnicos de Fase III: Estudios aleatorizados, controlados, en miles de pacientes Revisin regulatoria: Evaluacin exhaustiva de datos de manufactura, estabilidad y seguridad A la fecha de esta publicacin, la investigacin sobre sistemas transdrmicos de GLP-1 se encuentra principalmente en etapas preclnicas o de prueba de concepto temprana

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2014 May 1;44(5):480-8.

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Public trial doses can help you understand research, but they should not guide self-treatment

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J Biol Chem 274:1206112066

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