Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs
| Autor: | Kraus, V.B. †, Simon, L.S. ‡, Katz, J.N. §, Neogi, T. ‖, Hunter, D. ¶, Guermazi, A. #, Karsdal, M.A. †† |
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| Zdroj: | In Osteoarthritis and Cartilage April 2019 27(4):571-579 |
| Databáze: | ScienceDirect |
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