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The Development of Population Pharmacokinetic Model and a R Shiny App

The Development of Population Pharmacokinetic Model and a R Shiny App for CSL689 in Subjects with FVII Deficiency


  • rVIIa-FP (CSL689) is a recombinant fusion protein, linking coagulation factor VIIa with albumin, for the treatment and prophylaxis of bleeding in subjects with congenital FVII deficiency, including perioperative settings.

  • A population PK (popPK) model was developed from the Phase I studies in adult FVII deficiency subjects, to simulate and select appropriate on-demand/surgery/prophylactic dose regimens in adults and adolescents for the Phase II study.

  • An R Shiny application (app) was also developed, which generates and displays the simulation results for various dosing scenarios in real-time, facilitating more rapid and well-informed decision-making.



Acop rVII-FP pop PK poster_092018_1
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