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Assessment of the safe and efficacious dose of the selective progesterone receptor modulator vilaprisan for the treatment of patients with uterine fibroids by exposure–response modelling and simulation

AIMS: We report population pharmacokinetic (popPK) and exposure–response (E–R) analyses for efficacy (induced amenorrhoea [IA]) and safety (unbound oestradiol [E2] concentrations) of the selective progesterone receptor modulator vilaprisan. Results were used to inform the dose for the Phase 3 progra...

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Detalles Bibliográficos
Autores principales: Sutter, Gabriele, Frei, Matthias, Schultze‐Mosgau, Marcus‐Hillert, Petersdorf, Kathrin, Seitz, Christian, Ploeger, Bart A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9292591/
https://www.ncbi.nlm.nih.gov/pubmed/34327754
http://dx.doi.org/10.1111/bcp.15014