Bioequivalence and Bioavailability Forum • estimated AUC72

estimated AUC72 [NCA / SHAM]

posted by sam – India, 2013-10-08 15:15 (3846 d 05:50 ago) – Posting: # 11622
Views: 10,077

Dear Ratnakar,

❝ I can very well implement your suggestion of the partial area, provided it is the best approach for truncated study.

The approach of the partial area suggested by Helmut is well accepted by any of the Regulatories body and this is only a correct approach for calculation of AUC72 for the truncated design.
I have experience of n number of studies which has been submitted and got approved by various regulatory body.

Best Regards,
Sam

Complete thread:

Actual time for PK analysis ratnakar1811 2013-10-07 08:07
- estimated AUC72 Helmut 2013-10-07 13:36
  - estimated AUC72 ratnakar1811 2013-10-08 08:20
    - estimated AUC72sam 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 AUC72 Dr_Dan 2013-10-15 12:24
        estimated AUC72 jag009 2013-10-15 21:53
        
        estimated AUC72 ratnakar1811 2013-10-17 09:34