Bioequivalence and Bioavailability Forum

Put the sickle to the corn [General Statistics]

posted by Relaxation – Germany, 2018-02-13 11:37 (2256 d 18:33 ago) – Posting: # 18411
Views: 15,440

Dear All.

Although I am lost regarding most of the mathematical discussion, I understood, that ASA seems to misbehave - and this information catched my exe.

❝ 100 mg ASA (actually 5 × 20 mg tablets).

To be very brief, from my experience, a study with multiple tablets under fasted conditions always could/might (will) result in an increase in variability in particular in Cmax.
To visualize, imagine all tablets reach the stomach immediately, but every tablet has an individual chance to be emtyied into the intestine.
So we might see subjects with one single peak (5 tablets at once) or subjects with 5 individual peaks (blurred together) and anything in between. These subjects will then show artificially low Cmax values that will not correlate at all.

Looking at the individual profiles posted above I think I see at least a few "irregular profiles" even including late tmax at about 2 hours.

I am not saying that this is a/the solution, but this may be one aspect helping to understand, why the correlation for ASA is lousy in comparison with other APIs and drug products.

Just flashed through my mind.

Best regards,

Relaxation.

Complete thread:

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      - The mysterious ρ -between or within studies Astea 2018-02-11 17:34
        
        The mysterious ρ -between or within studies d_labes 2018-02-11 19:36
        The mysterious ρ within studies Helmut 2018-02-11 22:48
- Power and type I adjustment for 222BE when several PK prams considered ElMaestro 2018-02-11 18:43
  - Power and type I adjustment for 222BE when several PK prams considered nobody 2018-02-12 09:10
    - reminds me of something ElMaestro 2018-02-12 09:18
      - reminds me of something nobody 2018-02-12 09:38
        
        Hammer to fall Astea 2018-02-12 18:37
        
        Put the sickle to the corn Helmut 2018-02-13 01:37
        
        Put the sickle to the corn Astea 2018-02-13 08:27
        
        Put the sickle to the corn Helmut 2018-02-13 12:45
        
        Put the sickle to the cornRelaxation 2018-02-13 10:37
        
        multiple units, lag-times Helmut 2018-02-13 13:31

Put the sickle to the corn [General Sta­tis­tics]

Complete thread:

Put the sickle to the corn [General Statistics]