Bioequivalence and Bioavailability Forum

Non-informative “profiles” [General Statistics]

posted by Ohlbe – France, 2014-03-11 14:47 (4477 d 21:28 ago) – Posting: # 12596
Views: 11,736

Dear Helmut,

❝ Well, that’s not what I would call informative profiles (EMA’s term: “reliable estimates of peak and extent of exposure”). Canada’s HPFB/TGD once stated that two points qualify for AUC and one for C_max I’m not sure whether this really make sense. In PK modeling you could deal with censored data, but IMHO in NCA you would be reaching beyond meaningful boundaries.

Well, cough... If that's for the test formulation, I somewhat disagree... If you have a formulation that gives you no, or just one or two, concentration above the LLOQ, that's relevant information. I have no idea how these should be analysed, but just dropping them from the analysis is not an idea I'm comfortable with.

—
Regards
Ohlbe

Complete thread:

Log-transformation of "null" PK parameters fno 2014-03-11 12:18
- Non-informative “profiles” Helmut 2014-03-11 13:29
  - Non-informative “profiles”Ohlbe 2014-03-11 13:47
    - Non-informative “profiles” Helmut 2014-03-11 14:04
      - Non-informative “profiles” fno 2014-03-11 15:52
        
        Non-informative “profiles” Helmut 2014-03-11 17:22
        
        Non-informative “profiles” ElMaestro 2014-03-11 18:50
        
        OT: log(0) - NaN, NA or what d_labes 2014-03-12 08:59
        
        OT: log(0) - NaN, NA, ‘.’, –∞, or empty Helmut 2014-03-12 15:31
        
        Non-informative “profiles” fno 2014-03-12 11:18
        
        Non-informative “profiles” nobody 2014-03-12 13:18

Non-informative “profiles” [General Sta­tis­tics]

Complete thread:

Non-informative “profiles” [General Statistics]