Bioequivalence and Bioavailability Forum

Carved in stone? [Study Assessment]

posted by luvblooms – India, 2013-08-02 10:37 (4301 d 00:56 ago) – Posting: # 11163
Views: 25,681

Dear Sam

❝ Its real.

I must say a very very BOLD decesion to go ahead with the study!!

❝ Also confirm me if i do redosing study and it confirms the outlier. should I present the data without that subjects as discussed by John.

Now coming to your redosing study, you can do it but it is very difficult to justify and sometime inconclusive as well.

We have done it once for USFDA and really regreted it. In our study we found a unique situation, where the one volunteer who behaved abruptly in the first study was ok but other 2 volunteers decided to act wildly and the total study was inconclusive.

But since you have already taken some bold steps, you can try the redosing process and if lucky, submit the data with redosing study but you need to define it properly in the redosing protocol.

And If I am right, you have to submit the full study results.
I mean to say

Orignal study data including outlier
You can not remove the outlier from study, If you are able to find your proposed outlier as real outlier in redosing study, the data of the outliers in the orignal study to be replaced with the data obtained in the redosing study and then BE to be calculated.

It is a long shot looking to your CI limits (79.28% - 88.61) but worth trying.

BTW, was the study fasting or fed? And what was the outcome of other study (fasting/fed)?

Better

—
~A happy Soul~

Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15
- AUCextrap more than 20% ElMaestro 2013-08-01 10:29
  - AUCextrap more than 20% sam 2013-08-01 11:21
    - AUCextrap more than 20% ElMaestro 2013-08-01 11:39
      - AUCextrap more than 20% sam 2013-08-01 12:01
        
        AUCextrap more than 20% Helmut 2013-08-01 12:52
    - forced BE d_labes 2013-08-01 11:59
      - Gambling ♠ ♣ ♥ ♦ Helmut 2013-08-01 13:31
- AUCextrap more than 20% Helmut 2013-08-01 12:32
  - AUCextrap more than 20% sam 2013-08-01 12:55
    - 46% power in study planning? Helmut 2013-08-01 13:18
      - 46% power in study planning? sam 2013-08-01 13:40
        
        46% power in study planning? jag009 2013-08-01 20:04
        
        Re-dosing Helmut 2013-08-02 03:32
        
        Re-dosing jag009 2013-08-02 05:10
        
        Re-dosing Helmut 2013-08-02 14:44
        
        46% power in study planning? sam 2013-08-02 07:00
        
        Carved in stone? Helmut 2013-08-02 03:22
        
        Carved in stone? sam 2013-08-02 07:02
        
        Carved in stone?luvblooms 2013-08-02 08:37
        
        Carved in stone? sam 2013-08-02 09:01
        
        Ethics (again) Helmut 2013-08-02 14:53
        
        Update jag009 2013-08-02 17:25
        
        Update Helmut 2013-08-02 18:11
        
        Update jag009 2013-08-02 20:11
        
        Outliers (CAN) Helmut 2013-08-02 20:56
        
        Outliers (CAN) jag009 2013-08-02 22:23
        
        OT: Expert Helmut 2013-08-03 10:11
        
        Update jag009 2013-08-02 22:29
        
        Update ElMaestro 2013-08-02 23:08
        
        Update jag009 2013-08-03 23:00
        
        Update luvblooms 2013-08-05 06:02
        
        Update jag009 2013-08-05 20:14

Carved in stone? [Study As­sess­ment]

Complete thread:

Carved in stone? [Study Assessment]