Bioequivalence and Bioavailability Forum

Hi mmw,

❝ According to the EMA GL[…] "Subjects should preferably be non-smokers"

Should preferrably be does not mean have to be, must be, etc.

❝ I have referred BE studies of Nicotine Replacements Therapy (NRT) […] and noticed that only healthy-smokers had been used in NRT products BE studies.

Yep. In all studies I have seen as well.

❝ 1. What is the rationale behind the selection of healthy smokers for BE studies of NRT products? ?

Smokers are addicted to nicotine and adapted to the effects/AEs. You don’t want to have a lot its AEs caused in non-smokers.

❝ 2. Can we use healthy non-smokers for BE study of NRT products? Can we follow the GL only?

I wouldn’t. The GL is not a law.

❝ 3. Is there any regulatory compulsion for use of healthy smokers in BE study of NRT products? Specially EU.

Not that I recall.