Bioequivalence and Bioavailability Forum • Calculation of AUCt, AUCall, AUCinf...

Calculation of AUCt, AUCall, AUCinf... [NCA / SHAM]

posted by Ohlbe – France, 2007-11-28 11:37 (6367 d 02:41 ago) – Posting: # 1340
Views: 27,386

Dear HS,

Hey, that's a nice post and a nice demonstration. By the way, nice new home page, too.

❝ It's definitely better to go with Method #5, which is standard according to the WHO, European any many other countries' guidelines.

I couldn't find any recommendation on this in the EU BE guideline, which only states that the method used to calculate AUC should be specified, or in the old PK in man guideline. Anyway the EU BE guideline recommends the use of AUCt as the "most reliable estimate of the extent of absorption" anyway. I couldn't find it either in the WHO guideline, which mentions "Clast" and defines it as "last measurable concentration". I couldn't say about BA trials (where there would be more modelling anyway) but I think I've only seen once a BE trial using Method #5.

Is there any recommendation I have missed in EU or WHO guideline, or made at a conference ?

Regards
Ohlbe

Complete thread:

Calculation of AUCt yckim 2007-11-27 02:46
- Calculation of AUCt, AUCall, AUCinf... Helmut 2007-11-27 22:02
  - Calculation of AUCt, AUCall, AUCinf... yckim 2007-11-28 02:44
    - Calculation of AUCt, AUCall, AUCinf... Helmut 2007-11-28 03:49
      - Calculation of AUCt, AUCall, AUCinf... jmlee 2008-10-10 08:29
        
        Calculation of AUCt, AUCall, AUCinf... Helmut 2008-10-10 17:48
        Calculation of AUCt, AUCall, AUCinf... mittyri 2014-03-19 19:15
        
        Errors happen d_labes 2014-03-20 08:26
        
        Errors happen fno 2014-03-20 11:03
  - Calculation of AUCt, AUCall, AUCinf...Ohlbe 2007-11-28 10:37
    - Calculation of AUCt, AUCall, AUCinf... Helmut 2007-11-28 12:28
      - References Helmut 2007-11-28 17:58