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Diferencias en las dosis aprobadas y retraso en los medicamentos aprobados entre 2012 y 2021: una comparación entre

Kosuke Koyama1, Yuan Abe1, Sho Kodama1

  • 1Faculty of Pharmaceutical Sciences, Tokyo University of Pharmacy and Life Sciences, 1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan.

Biological & pharmaceutical bulletin
|August 27, 2025
PubMed
Resumen

Los ensayos clínicos multinacionales (ECM) reducen el retraso y las diferencias de dosis aprobadas entre Japón y los Estados Unidos para nuevos medicamentos. Este estudio confirma que las MCT simplifican el desarrollo global de medicamentos y la alineación regulatoria.

Palabras clave:
diferencia de dosisestrategia de desarrollo de fármacosretraso en el consumo de drogasensayo clínico multinacional

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