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.
- I wanted to perform Clinical Trial Simulations to optimise the pivotal trial using the pilot study data generated in the healthy volunteers?
- Can we explore the reasons for failure of pivotal studies due to different factor
- 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
