Bioequivalence and Bioavailability Forum

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

posted by Helmut – Vienna, Austria, 2019-10-16 11:53 (301 d 20:50 ago) – Posting: # 20692
Views: 1,931

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 t_max.
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).

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Helmut Schütz

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Complete thread:

Emesis criteria for study comparing IR vs. MR formulations Rock 2019-10-16 13:38 [Study Performance]
- 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
  - 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 [Study Per­for­mance]

Complete thread:

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