Bioequivalence and Bioavailability Forum

Hi Helmut,

Thanks for your esteemed reply.

We wish to carry out BE studies for European Region (EU-EMA) and as per Current effective EU guidance “Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party, Revision 7” does not categorically specify this molecule into NTI category.

Kindly suggest whether we can design a study with a normal acceptable range (80-125)% for Cmax and AUCt or with the acceptance range of (90-111)% considering NTI.


Thanks & Regards
Anu