cutoff time point based on PK? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2017-11-25 13:46  – Posting: # 18005
Views: 1,784

Hi Biostats,

» Is there any scientific method or formula to calculate the time point for truncating the partial AUC (cutoff time point)?

Scientific? Yes. That would be based on PD – not PK as the GL recommends (regulations  science). Examples of biphasic MR products:The first part is for rapid onset of effect and the second for its maintenance. In both cases the cut-off points are based on clinical studies and the justification as given by the FDA.

If have seen studies trying to show BE to Concerta with a cut-off of 2 hours. That’s ridiculous. In many subjects we don’t see a trough between the IR and MR parts in the profiles (only a “shoulder”). Expect large intra-subject variability and opt for reference-scaling (requires a replicate design).

Cheers,
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
20,113 posts in 4,245 threads, 1,383 registered users;
online 11 (2 registered, 9 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 17:24 CET

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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