Study design multiple dose stuy - circadian PK [Design Issues]

posted by Summertime – Slovenia, 2020-03-26 16:29  – Posting: # 21301
Views: 536

Hi to all.

My question is related to below Helmuts post:

» » A case of Steady state bioequivalence study in which dose is administered twice daily from Day XX to Day XX. Suppose Day 01 to Day 07 where on day 07 only morning dose will be administered.
» This is only acceptable if you know that there are no circadian differences in PK. Otherwise, you have to administer both doses on day 7 as well and assess the complete 24 hours profile.

Is this really necessary also for non-pulsatile modified-release forms (especially when efficacy is not compromised due to circadian differences in PK)? I see many challenges in this approach - especially I find it very volunteer unfriendly, as relatively intense blood sampling would be done also during the night.
Helmut, is this your personal opinion what would be the most right thing to do or you came across that demand/opinion form regulatory authorities? Would highly appreciate your explanation.

Thanks in advance,

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