Bioequivalence and Bioavailability Forum

Dear Sachin

You Should try it like this


Samples Required for BE Study (Fasting and Fed):
72 (Dosing (32) + verification purpose (2) and extra dispensed (2) = 36 samples/study)

Samples Required for Retention: 2 times of release test (for eg. Release test uses 36 samples you can go for 72 as retention )

Also consider the available pack size showing utilization break up and mention it in your request to DCGI.
Eg: Total requirment From above example ~144
But drug is available in pack size of lets say 60, then you ahould apply for 3 packs (3*60=180)



Hope this will help

Regards