Bioequivalence and Bioavailability Forum

Dear All,

It has been learned so far that age, BMI, posture, composition of meal, etc should be uniform as strictly as possible because we measure only PK not efficacy. Thus by maintaining uniform conditions except Test/Reference we can identify formulation difference between test and reference in BE study.

It is recommended by regulatory authorities to prove the bioequivalence in fed state (Fed BE Study) in addition to fasting state (Fasting BE Study), when the drug is having food effect/ modified release formulation. This may be because to ensure the BE and thus therapeutic equivalence in fed conditions.

So, apart from fast/fed study is it not required to prove the BE with respect to other restrictions like different postures, abnormal BMI, old/child population ?

And if it is not required to conduct such studies why only fed study is being recommended ?

Keep answering.