Optimizing the sample size of a bridging study using Simulx, an application of the MonolixSuite

Conference: ACoP
Software: Simulx®


Reference asthma treatment

  • Current standard-of-care
  • Approved globally (also in China)

New asthma treatment

  • FDA approved
  • does not include Chinese patients
  1. Plan a bridging study for approval in China
  2. What is the sample size required for a trial in Chinese patients to show a difference in response between the two treatments?

By Pauline Traynard, Claude Magnard, Monika Twarogowska, Géraldine Ayral

Presented at ACoP 12 November 8-12, 2021