Bioequivalence and Bioavailability Forum

Dear ghouse1111!

❝ the ideal BMI range to include a volunteer in study is 19-26kg/m2.

Is it? Who says?

❝ If a person falls below or above the normal value it shows affect on drug distribution which indirectly shows affect on B.A.

I just made a quick survey of my most recent 110 studies - the ones I had in my online database - I was just too lazy to head for my backups.

I would support Jaime's point of view. 102 studies (93%) were performed in subjects with a BMI of 18–29 kg/m². I never got any problems in approval…

Just think about:

• Differences in distribution (between subjects) simply mean out in a cross-over design.
  
• At least for the FDA subjects should represent the population intended for treatment.

Since you made a strong statement (bold letters in you post…) do you have any reference or data supporting your statement?

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Whenever a theory appears to you as the only possible one,
take this as a sign that you have neither understood the theory
nor the problem which it was intended to solve. Karl R. Popper