Emesis criteria for study comparing IR vs. MR formulations [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2019-10-16 13:53  – Posting: # 20692
Views: 1,294

Hi Rock,

» In a study comparing Test (Immediate Release) vs. Reference (Modified Release) formulations, on which formulations the withdrawal criteria on emesis should be based …

For the IR formulation most people opt at two times the median tmax.
For the MR formulation the entire intended dosing interval.

» … and why?

IR: That’s the inflection point of the profile where absorption is essentially (98.44%) complete.
MR: Since you likely are facing flip-flop PK (where the late part of the profile represents absorption). Hence, for o.a.d. 24 hours, for b.i.d. 12 hours (even if you administered it only once).

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
20,466 posts in 4,298 threads, 1,414 registered users;
online 23 (0 registered, 23 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 04:33 CEST

Learning of many things
does not teach intelligence.    Heraclitus of Ephesus

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