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A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China
On June 23, 2020, Prolia(®) (denosumab) was approved by the National Medical Products Administration (NMPA) in the People’s Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is 普罗力, a tr...
Autores principales: | Storm, Neal E., Chang, Wen, Lin, Tzu-Chieh, Lange, Jeff L., Bradbury, Brian, Critchlow, Cathy W., Galson, Steven K. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688380/ https://www.ncbi.nlm.nih.gov/pubmed/34633649 http://dx.doi.org/10.1007/s43441-021-00342-4 |
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