A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A

BACKGROUND: Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I–I/II studies, emicizumab reduced the bleeding frequency in patients with severe hemophilia A, regardless of the presence of factor VIII inhibitors, at once-weekly...

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Detalles Bibliográficos
Publicado en:Clin Pharmacokinet
Main Authors: Yoneyama, Koichiro, Schmitt, Christophe, Kotani, Naoki, Levy, Gallia G., Kasai, Ryu, Iida, Satofumi, Shima, Midori, Kawanishi, Takehiko
Formato: Artigo
Idioma:Inglês
Publicado: Springer International Publishing 2017
Assuntos:
Original Research Article
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC6061395/
https://ncbi.nlm.nih.gov/pubmed/29214439
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40262-017-0616-3
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