Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability. Delayed access to these drugs increases the risk of mortality of patients with...

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Detalles Bibliográficos
Autores principales: Matsushita, Shunsuke, Tachibana, Keisuke, Kusakabe, Tetsuya, Hirayama, Ryuichi, Tsutsumi, Yasuo, Kondoh, Masuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212755/
https://www.ncbi.nlm.nih.gov/pubmed/33048440
http://dx.doi.org/10.1111/cts.12898

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212755/
https://www.ncbi.nlm.nih.gov/pubmed/33048440
http://dx.doi.org/10.1111/cts.12898

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