Bioequivalence and Bioavailability Forum

Redosing study… [Study Assessment]

posted by GSTATS – India, 2011-06-16 18:12 (5079 d 02:46 ago) – Posting: # 7141
Views: 10,840

Dear Dr Dan,

❝ The following scenarios are possible:

❝ • If the ratios of AUCt, and Cmax of the suspected outlier lie outside the corresponding acceptance range and all the ratios of AUCt and Cmax for the control subjects fall within the acceptance range, then the outlying subject will be confirmed as an outlier. The pharmacokinetic and statistical analysis for the pivotal study will then be performed without data for the outlying subject.

I have doubt in the scenario mentioned above. If the suspected subject repeats the behavior as in pivotal study (i.e very low value of PK parameter for test as compared to Reference or vice-versa) then the behavior of the subject is not by chance and it may repeat for other subjects too (in larger pool of subjects), with same biological conditions. And for these particular type of subjects, two products are not bio-equivalent.

So, in my opinion, if suspected and control subjects doesn't show an outlying behavior in re-dosing study then we can exclude that subject from the pivotal study.

Regards,
GSTATS

—
Let Noble Thoughts come from Every Side: RIG VEDA

Complete thread:

Redosing study… H.Patel 2011-06-15 16:28
- Redosing study… swapnil.kuche 2011-06-16 08:35
  - Redosing study… Dr_Dan 2011-06-16 12:37
    - Redosing study… Helmut 2011-06-16 12:52
    - Redosing study…GSTATS 2011-06-16 16:12
    - Redosing study… luvblooms 2011-06-17 06:34
      - Redosing study… ElMaestro 2011-06-17 09:16
        
        Redosing study… luvblooms 2011-06-17 12:50
        
        Redosing study… ElMaestro 2011-06-17 13:09
        
        Redosing study… luvblooms 2011-06-18 11:47
        
        Redosing study… GSTATS 2011-06-17 16:57
        
        Redosing study… luvblooms 2011-06-18 11:53

Redosing study… [Study As­sess­ment]

Complete thread:

Redosing study… [Study Assessment]