Bioequivalence and Bioavailability Forum

Dear Khageswara Rao,

❝ IN FDA it is not mentioned BMI criteria so is it we can mention BMI criteria-18.5 to 30.0 kg/m² (including both) in protocol.

What is written in the 2003 BE guidance is We recommend that restrictions on admission into the study generally be based solely on safety considerations.

Similarly, the 2021 draft guidance on BE for ANDA states We also recommend that any restrictions on admission into a study be primarily based on safety considerations.

OK, they have changed from solely to primarily... But BMI limits are not related to safety.

The 2003 guidance also states that This guidance recommends that in vivo BE studies be conducted in individuals representative of the general population.

So overall: if you want to use restrictive inclusion criteria, be prepared to justify them (e.g. explaining that collecting blood samples from subjects with a very high BMI may be challenging - though they could object that vein accessibility might be a more relevant inclusion criterion).