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RegisterEmesis criteria for study comparing IR vs. MR formulations [Study Performance]
posted by Helmut 
– Vienna, Austria, 2019-10-16 13:53 (461 d 12:45 ago) – Posting: # 20692
Views: 2,361
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).
» 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 🖖
Helmut Schütz
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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:
- Emesis criteria for study comparing IR vs. MR formulations Rock 2019-10-16 13:38 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Emesis criteria for study comparing IR vs. MR formulationsHelmut 2019-10-16 13:53
- Emesis criteria for study comparing IR vs. MR formulations nobody 2019-10-16 15:22
- Almost OT Helmut 2019-10-16 17:24
- Almost OT nobody 2019-10-16 18:41
- Completely OT Helmut 2019-10-16 19:02
- Almost OT nobody 2019-10-16 18:41
- Almost OT Helmut 2019-10-16 17:24
- median Tmax mittyri 2019-10-17 00:01
- median Tmax Helmut 2019-10-17 08:42
- median Tmax jag009 2019-10-22 21:26
- Emesis criteria for study comparing IR vs. MR formulations nobody 2019-10-16 15:22
- Emesis criteria for study comparing IR vs. MR formulationsHelmut 2019-10-16 13:53
Ing. Helmut Schütz