Bioequivalence and Bioavailability Forum • FDA more straight?

FDA more straight? [BE/BA News]

posted by luvblooms – India, 2012-03-09 07:55 (5212 d 02:01 ago) – Posting: # 8240
Views: 27,957

Dear HS/D_labes/El

Does that mean that the same would be applicable to Dexlansoprazole DR capsules as well???

What about varying rate of gastric emptying??

We have done a few studies on the said molecule and the first peak comes at 3 hr (range 30 min to 5 hrs) and second at 6 hrs (3-8 hrs) and the main reason was varying gastric emptying??

Then what should be the cut off time???? ;-)

You fix any cut off time and you will surely fail for partial AUC!!!!

Life of a generic scientist is getting tougher day by day!!!!!

Regards

Luv

—
~A happy Soul~

Complete thread:

EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
  - EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
    - EMA: Q&A on biphasic MR products ElMaestro 2012-03-07 19:20
- EMA vs. FDA d_labes 2012-03-07 10:26
  - MPH examples Helmut 2012-03-07 14:22
    - MPH examples d_labes 2012-03-07 16:18
      - MPH examples Helmut 2012-03-08 01:07
        
        FDA more straight? d_labes 2012-03-08 08:29
        
        and what about power? ElMaestro 2012-03-08 11:37
        
        and what about power? d_labes 2012-03-08 13:26
        and what about power? Helmut 2012-03-08 13:36
        
        FDA more straight? Helmut 2012-03-08 12:51
        
        FDA more straight?luvblooms 2012-03-09 06:55
        
        Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
        
        Multiphasic MR ≠ DR jag009 2012-03-28 15:29
        
        Metadate CD (30/70) Helmut 2012-03-28 15:45