Bioequivalence and Bioavailability Forum • estimated AUC72

estimated AUC72 [NCA / SHAM]

posted by Dr_Dan – Germany, 2013-10-15 14:24 (4265 d 13:58 ago) – Posting: # 11666
Views: 11,695

Dear Ratnakar

❝ Query 1: What approach we should implement while comparing such a variable AUCt? Is it a correct method to compare AUC8hrs to AUC36 hrs? Or Is there any other statistical method which we should adopt for such situation?

As John already pointed out it is the intra-subject comparison that we are talking about when evaluation bioequivalence. Do you compare fast vs. slow metabolizers (i.e. inter-subject comparison)?

❝ Query 2: Since extrapolation is more than 20% how do we justify such situation?

Could you please explain how do you extrapolate AUC0-inf?
This would help
Best Regards,
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Actual time for PK analysis ratnakar1811 2013-10-07 08:07 [NCA / SHAM]
- estimated AUC72 Helmut 2013-10-07 13:36
  - estimated AUC72 ratnakar1811 2013-10-08 08:20
    - estimated AUC72 sam 2013-10-08 13:15
    - estimated AUC72 Helmut 2013-10-08 13:51
      - estimated AUC72 ratnakar1811 2013-10-10 11:30
        
        estimated AUC72 jag009 2013-10-13 21:17
        
        estimated AUC72 ratnakar1811 2013-10-15 06:23
        
        estimated AUC72Dr_Dan 2013-10-15 12:24
        estimated AUC72 jag009 2013-10-15 21:53
        
        estimated AUC72 ratnakar1811 2013-10-17 09:34