Carry-over in pre-dose samples for steady state BE [Study As­sess­ment]

posted by hirenpharm – Ahmedabad, 2019-03-29 20:56 (540 d 21:24 ago) – Posting: # 20103
Views: 2,670

Hello everyone,

We did a multiple dose (5 weeks, 1 TDS patch every week) bioequivalence study. The BE was assessed at week 5 at steady state. It was a 3-period study. In period 2 and 3, we observed some carry-over from the previous period treatments. I remember, the 5% of Cmax rule for single-dose studies. But, can someone please throw some light on how to handle this carry-over in multiple dose steady state studies? Does the carry-over in week 1 pre-dose really impact week 5 steady state parameters? any regulatory guidance/published articles will be really helpful.


Edit: Category changed; see also this post #1[Helmut]

Dr. Hiren Mehta

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