Bioequivalence and Bioavailability Forum

Dear All,

We have conducted Dose proportionality study for ANVISA submission, study was comfortably meeting the criteria. Hence, decided to submit same study to TGA by making the report in TGA format as well additional documentation required for TGA. The subjects were enrolled as per LIC for age and weight chart as the study planned for ANVISA. 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.

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

Thanks in advance for your help.

Thanks,

Vardhan