Bioequivalence and Bioavailability Forum • Disagree with Nathan

Disagree with Nathan [Design Issues]

posted by jag009 – NJ, 2013-10-28 21:36 (4623 d 23:01 ago) – Posting: # 11799
Views: 8,458

Hi all,

❝ Well, these are simulated data (^…) of a fast bolus – though in the real world we never would see the highest concentration at t=0*. Note that Nathan calculated the AUC by the lin/log-trapezoidal rule...

Agree with Helmut. Depending on the product the plasma concentrations may fluctuate (bounce up and down) over the time course of PK sampling window such that AUC value may vary between different time sampling schemes.

Take a look at a nifedipine XL blood level profile for example. If I remember correctly, it was bouncy.

I think from a NDA pt of view then it might not be super critical if one just wants to delineate the PK. In the world of BE (ANDA or 505(b)2) then yes it is important.

Partial AUC is another beast. Don't even get me started on that recent fiasco.

John

Complete thread:

Using sampling “windows” for PK blood samples mittyri 2013-10-23 09:53
- Using sampling “windows” for PK blood samples jag009 2013-10-23 16:50
  - Using sampling “windows” for PK blood samples mittyri 2013-10-24 15:35
    - Using sampling “windows” for PK blood samples jag009 2013-10-25 05:12
      - Disagree with Nathan Helmut 2013-10-28 15:48
        
        Disagree with Nathanjag009 2013-10-28 20:36
      - Using sampling “windows” for PK blood samples teuscher 2013-11-15 03:55
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 10:32
        
        Using sampling “windows” for PK blood samples teuscher 2013-11-15 15:16
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 15:55
        
        Lin/log trapezoidal Helmut 2013-11-17 14:55