Multiphasic & pulsatile MR products [Software]

posted by Helmut Homepage – Vienna, Austria, 2018-11-01 23:29 (719 d 20:11 ago) – Posting: # 19520
Views: 2,127

Hi Simon,

» Further more I'm not sure what you would mean my Cmax2 and Tmax2; there can only be one maximum...

Haha, „There can be only one” of the Highlander? For multiphasic or pulsatile MR products the EMA wants a pre-specified cut-point for the AUC (like the FDA does). So far, so good.
In its eternal wisdom the EMA wants not only the (global) Cmax but also the Cmax within each interval (GL Section 6.8.1.1).

@Robin: Trivial in Phoenix. Perform NCA on the entire data set (PHX will do the interpolation of pAUCs if actual times ≠ scheduled times). Split the original data set by the cut-off time (scheduled, not actual time). Run NCA on both (deselect everything except Cmax and tmax). Rename Cmax to Cmax1, Cmax2. Join or merge the results.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,174 posts in 4,412 threads, 1,476 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Wednesday 20:41 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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