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

Authors: Traynard P, Magnard C, Twarogowska M, Ayral G
Conference: ACoP
Keywords: Asthma, China, Chinese patients, FDA approved, monolixsuite, MonolixSuite Playlist, simulx
Software: Simulx®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Goal

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