Bioequivalence and Bioavailability Forum

Dear All,

According to the EMA GL CPMP/EWP/QWP/1401/98 Rev. 1/ Corr**London, 20 January 2010, "Subjects should preferably be non-smokers"

However, I have referred BE studies of Nicotine Replacements Therapy (NRT) Products (Gum, lozenges, microtab, mints etc) and noticed that only healthy-smokers had been used in NRT products BE studies.

My queries are:

1. What is the rationale behind the selection of healthy smokers for BE studies of NRT products? ?
   
2. Can we use healthy non-smokers for BE study of NRT products? Can we follow the GL only?
   
3. Is there any regulatory compulsion for use of healthy smokers in BE study of NRT products? Specially EU.

Thanks and regards,

MMW