BID vs. QD dosing in a generic multiple dose BE study [Design Issues]
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:
Kind regards,
Nisha
Edit: Category changed. [Helmut]
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:
- 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…
- 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?
- I believe QD would be better ethically
Kind regards,
Nisha
Edit: Category changed. [Helmut]
Complete thread:
- BID vs. QD dosing in a generic multiple dose BE studyNisha 2015-07-20 13:03 [Design Issues]