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Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval
The basic components of regulatory and supporting policies for orphan drug development appear similar between the United States and Japan, but drugs designated as orphan drugs have been different between the 2 countries. The probabilities of development success (ie, marketing approval) in designated...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972571/ https://www.ncbi.nlm.nih.gov/pubmed/31364772 http://dx.doi.org/10.1002/jcph.1501 |