Bayesian statistics and clinical trial designs for human cells and tissue products for regulatory approval

INTRODUCTION: In order to obtain premarket approval for medical products derived from human cells or tissues in the United States (US), the European Union (EU), and Japan, data from clinical trials are typically required to evaluate product efficacy and safety. Clinical investigators or study sponso...

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Detalles Bibliográficos
Autores principales: Jokura, Yoji, Yano, Kazuo, Watanabe, Natsumi, Yamato, Masayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japanese Society for Regenerative Medicine 2016
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581844/
https://www.ncbi.nlm.nih.gov/pubmed/31245506
http://dx.doi.org/10.1016/j.reth.2016.09.001

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581844/
https://www.ncbi.nlm.nih.gov/pubmed/31245506
http://dx.doi.org/10.1016/j.reth.2016.09.001

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