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

posted by hirenpharm – Ahmedabad, 2019-03-29 20:56 (547 d 12:06 ago) – Posting: # 20103
Views: 2,679

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

Complete thread:

Activity
 Admin contact
21,076 posts in 4,394 threads, 1,469 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Sunday 10:03 CEST (Europe/Vienna)

Politicians use statistics like drunkards use lampposts:
not for illumination, but for support.    attributed to Hans Kuhn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5