Bioequivalence and Bioavailability Forum • Validation?

Validation? [Software]

posted by gcpatel126 – India, 2016-01-11 15:54 (3811 d 07:08 ago) – Posting: # 15813
Views: 19,605

Hi Helmut,

Revisitng again this discussion, I want your suggestion on one scenario.

For one dose duration response study we have calculated ED50 and Emax by population model using Phoenix® NLME™ and we got below results.

ED50 : 120
Emax : -35

On other hand, using PPHARM software the values are as below,

ED50 : 50
Emax : -26

As you can see the difference is very big.

Now what you suggest, Should we go with Phoenix® NLME™ or PPHARM values ?

If we submit Phoenix NLME results to FDA, will be there any query from FDA as they are using PPHARM software ?

Please let us know your views.

Many thanks,
Dr. G C Patel

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Complete thread:

Emax and ED50: NLME gcpatel126 2015-12-09 18:08 [Software]
- Emax and ED50: NLME Helmut 2015-12-10 02:09
  - Emax and ED50: NLME gcpatel126 2015-12-10 17:34
    - Emax and ED50: NLME SDavis 2015-12-15 11:50
      - Emax and ED50: NLME gcpatel126 2015-12-29 15:49
        
        Emax and ED50: NLME Helmut 2015-12-29 17:46
        
        Emax and ED50: NLME gcpatel126 2015-12-29 18:04
        
        Emax and ED50: NLME Helmut 2015-12-29 19:36
        
        Emax and ED50: NLME gcpatel126 2015-12-30 14:43
        
        Emax and ED50: NLME Helmut 2015-12-30 14:56
        
        Emax and ED50: NLME gcpatel126 2015-12-30 15:19
        
        Validation? Helmut 2015-12-30 16:02
        
        Validation? gcpatel126 2015-12-30 17:47
        
        Validation? Helmut 2015-12-30 21:15
        
        Validation? gcpatel126 2015-12-31 07:06
        
        Validation?gcpatel126 2016-01-11 14:54
        
        EOD Helmut 2016-01-11 22:13