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

posted by Helmut Homepage – Vienna, Austria, 2017-11-25 12:46 (986 d 23:18 ago) – Posting: # 18005
Views: 2,165

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).

Dif-tor heh smusma 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
20,982 posts in 4,374 threads, 1,460 registered users;
online 14 (0 registered, 14 guests [including 11 identified bots]).
Forum time: Saturday 12:04 UTC (Europe/Vienna)

Patients may recover in spite of drugs or because of them.    John Gaddum

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