Clinical Trial Simulation of Bioequivalent Test & Escitalopram Formulations

Phoenix Certara Forums Modelling and Simulation
1

Hello All,

Iam working on “Applications of Modelling and Simulation in Bioequivalence” topic for my Phd.

I have recently completed Pilot bioequivalence analysis of Escitalopram Test and Reference Oral drug formulations in 24 humans using NONMEM and PHX-WinNonlin.

  1. I wanted to perform Clinical Trial Simulations to optimise the pivotal trial using the pilot study data generated in the healthy volunteers?
  2. Can we explore the reasons for failure of pivotal studies due to different factor
  3. Need the expert suggestions on how to utilise the data, model i have built further to draw a meaningful outcome/impact

I need expert guidance on performing CTS using the already built NLME model

If needed , I can share the model details

Regards

Team Jignyasa