Bioequivalence and Bioavailability Forum

Dear ghouse1111!

In my previous post I asked you for a justification of your statement.
'Following a set up' (or even worse, but often seen: 'because we have an SOP for it') is no science, but blind bureaucracy.

Now what have we got:

• I have a number of studies with BMI of 18–29 kg/m²,
• you have a number of studies (how many?) with BMI 19–26 kg/m²,

all of them showing no problems in approval. Fine.

I would strongly suggest to read the reference already given in Jaime's post.
BMI (or body weight, body surface,…) simply don't show up in the comparison of formulations for BE (… bridging studies are another issue).
Also see this retrospective analysis.

In the light of recent developments (matching characteristics of the population intended for treatment) I would advocate an even wider BMI-range than the one I used for many years!