Bioequivalence and Bioavailability Forum

Dear forum members,

In a recent MR study conducted, we found changes in half life between the reference and test MR formulations. The test was conducted in healthy volunteers.

Please help with the below:

1. Would changes in release of the active by the formulations (MR in particular)affect half-life? AUC was considerably lower in the test despite the high half life observed against the reference formulation.
   
2. What are the causes of failing to establish BE in Ctau (if other parameters have established BE)?
   
3. 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?

The study was conducted for EU submission.

Kind regards,
Tina

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Edit: Category changed. [Helmut]