Bioequivalence and Bioavailability Forum

Carved in stone? [Study Assessment]

posted by sam – India, 2013-08-02 11:01 (4706 d 04:14 ago) – Posting: # 11164
Views: 30,634

Hi Luvblooms,

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

I don’t have other option as the management wanted to go with this study

❝ 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.

Suppose I am doing re-dosing study and it meets all the acceptance. I am worried will USFDA accept the dossier as they don’t encourage the same.

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

❝ I mean to say

❝ a. Original study data including outlier

❝ b. You cannot 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 original study to be replaced with the data obtained in the redosing study and then BE to be calculated.

I don’t think the redosing study is performed to get the new data which can be used for substitution of the old data, as per my understanding it is only done to prove that the detected outlier is really outlier and the outlier will proved than you have the submit the data with and without outlier.

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

Its fed study and we are waiting the fasting study results.

Best Regards

Sam

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]