Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States
ABSTRACT Regulatory guidance documents exist on surrogate endpoints in the United States. In Japan, there are no established rules or guidance regarding the use of surrogate endpoints, and various aspects remain unclear. The aim of this study was to investigate the use of surrogate endpoints in Japa...
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| Principais autores: | , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Wiley
2025-11-01
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| Colecção: | Clinical and Translational Science |
| Assuntos: | |
| Acesso em linha: | https://doi.org/10.1111/cts.70413 |
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