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Use of a Bayesian approach in the design and evaluation of NCE2s
Taiwan’s regulatory agency defines New Chemical Entity 2 (NCE2) as a compound drug that has been approved and marketed for ten years in a top-ten pharmaceutically-advanced country but which is new in Taiwan. To apply for registration of NCE2 in Taiwan, a clinical trial may be conducted in Taiwan to...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Taiwan Food and Drug Administration
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332640/ https://www.ncbi.nlm.nih.gov/pubmed/29389583 http://dx.doi.org/10.1016/j.jfda.2017.07.010 |