Bioequivalence and Bioavailability Forum

Dear Vardhan!

❝ […] While compiling the data for making report for TGA, we came to know that some of the subjects were out of BMI range that is 17.65 to 31.43kg/m² (18.5 to 30 kg/m² as per TGA), But BMI criteria was not captured in the protocol.

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❝ Whether TGA will accepts this data as the BMI is out of the range. But study is meeting the criteria.

I don’t think that this should be a major problem. IMHO no guideline exists concerning proportionality studies. TGA’s BE GL states:

The inclusion/exclusion criteria should be clearly stated in the protocol. Subjects should be 18 years of age or older and preferably have a Body Mass Index between 18.5 and 30 kg/m².

(my emphases)
You have stated inclusion criteria in the protocol. The body height / mass range wasn’t the preferred one – but so what? Extreme values should not bother you in a cross-over design. Simply mention it in the report.