Bioequivalence and Bioavailability Forum

❝ If the strength developed is X but the posology says 2X dosing at a single time, should BE study be conducted with a dose of X or 2X?

1. Generally, the highest-marketed strength can be administered as a single unit. If warranted to achieve sufficient bioanalytical sensitivity, multiple units of the highest strength can be administered, provided the total single dose remains within the labeled dose range and the total dose is safe for administration to the study subjects.
   
2. The objective of BE study is not to determine efficacy of the product.
   
3. Ethical point of view if demonstration of BE (Not issue on bioanalytical method) is possible on single tablet then you can’t give two or multiples of tablets to healthy subjects although multiple of tablets are tolerable or safe.