Bioequivalence and Bioavailability Forum

Hi Everybody,
I am planning a multiple dose generic study vs. PR product which could be taken once or twice daily. The new EMA MR guidance does not specificaly deal with this sort of case.
I have a few questions:

1. Is there a preference from a regulatory point of view whether to design the study as BID or QD? I had seen some generic PARs for this product having QD dosing, however, they are older than 2010…
   
2. If there is no regulatory preference, what would be better from study design and PK perspective?
   • I believe QD would be better ethically
     
   • I was thinking that QD dosing would better allow to show BE in case profiles of test and reference are somewhat different. Is my assumption correct?
     
   • On the other hand, is it possible that ISCV of Cτ following QD would be more variable than Cτ following BID, as concentration is lower?
     
   • Are there other points I should take into consideration upon deciding?

Thanks in advance for your response,
Kind regards,
Nisha

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Edit: Category changed. [Helmut]