Bioequivalence and Bioavailability Forum

Dear Amira,

» Are subjects with deviations up to 10% in body mass index (for example: 31.5) eligible to be enrolled in bioequivalence studies?

Deviation from what ?

What did you put in your protocol ? Either the BMI is within the limits set in the protocol and the subject is eligible, or the BMI is outside the limits and the subject is not eligible. Full stop. There is no bargaining.

If your question relates to what limits should be put in the protocol: what is written in the guideline applicable to the country where your trial will be submitted ? If the guideline sets an upper limit of 30, then you should put that limit in the protocol. Again, no bargaining.

A high BMI may not be problematic by itself on a PK or BE point of view, but you may have difficulties drawing the blood samples.