Bioequivalence and Bioavailability Forum

Hi everybody,


I'm pharmacist doing my residency in pharmacology in Algeria, I prepare my post graduate disertation and the subject is the design of bioequivalence studies for Highly Variable Drug,

I try to understand the two approche of EMA and FDA for HVDP:

EMA:- does The European guideline prescribes a pilote study with replicate design to determine a CV withinsubject of the reference product to expand the limits in a pivotal replicate design study and apply the TOST with the news limits?
- the sample size is determined with CV withinsubject of bibliography?

FDA: what about the TOST ? or we juste apply mixed procedure for average BE? I dont understand what they do
thank you very much and sorry I have a bad english