Bioequivalence and Bioavailability Forum

Hi dhavalpanchal,

❝ We are working on a molecule which shows high intrasubject variability (around 85% for Cmax) and having Narrow Therapeutic Index.

To a not small proportion of people working in this field (on both sidses of the fence, I think) NTI and HVD are often mutually exclusive terms.

I'd recommend you to get central scientific advice. It could come down to a lot of specifics.

Best regards
EM.

Addendum: See e.g. here.
An EU regulator discussing NTI drugs that "If they were HVD/P, they could not be used since a very similar drug levels are necessary between administrations".