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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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| Publicat a: | Regen Ther |
|---|---|
| Autors principals: | , , , |
| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
Japanese Society for Regenerative Medicine
2016
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| Matèries: | |
| Accés en línia: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6581844/ https://ncbi.nlm.nih.gov/pubmed/31245506 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.reth.2016.09.001 |
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