Which Tmax to be consider in case of b.i.d. dosing? [NCA / SHAM]

posted by maulik963 – India, 2016-04-16 12:32 (1581 d 11:52 ago) – Posting: # 16209
Views: 3,271

Dear Helmut,

» Essentially it boils down to the target you had in mind developing the MR formulation. I would explore all PK-metrics in both intervals (pAUC0–τ, Cmax,0–τ, tmax,0–τ and pAUCτ–t, Cmax,τ–t, tmax,τ–t) as well as the global ones (AUC0–t, Cmax, tmax).

Thanks for your valuable information. I understood that all PK-metrics of both dosing interval should be provided but if i wish to conclude the result, Which Cmax i should consider?

Complete thread:

Activity
 Admin contact
21,026 posts in 4,382 threads, 1,460 registered users;
online 24 (0 registered, 24 guests [including 15 identified bots]).
Forum time: Saturday 00:24 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

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