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Back to the forum  Query: 2018-02-21 11:56 CET (UTC+1h)
 

Put the sickle to the corn [General Sta­tis­tics]

posted by Relaxation - Germany, 2018-02-13 10:37  - Posting: # 18411
Views: 875

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.

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