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Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development. Especially, the use of RWD to generate real-world evidence (RWE) in regulatory approval is currently undergoing a period of great change wit...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Frontiers Media S.A.
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9051225/ https://www.ncbi.nlm.nih.gov/pubmed/35492312 http://dx.doi.org/10.3389/fmed.2022.864960 |