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

posted by Helmut Homepage – Vienna, Austria, 2019-10-16 15:53 (1642 d 23:38 ago) – Posting: # 20692
Views: 3,994

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).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,983 posts in 4,822 threads, 1,648 registered users;
30 visitors (0 registered, 30 guests [including 6 identified bots]).
Forum time: 15:31 CEST (Europe/Vienna)

Complex, statistically improbable things are by their nature
more difficult to explain than
simple, statistically probable things.    Richard Dawkins

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