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Back to the forum  Query: 2018-02-22 21:48 CET (UTC+1h)
 

Truncted AUC, low variability [Design Issues]

posted by jag009 - NJ, 2017-08-17 23:50  - Posting: # 17707
Views: 1,677

Hi Helmut,

» It is an open question what a “long half-life drug” is. An numerous conferences both the FDA and the EMA refused to give a definition. Only the Canadian HPFB formerly stated t½ ≥24 hours.

So far no problems for me w FDA. I've ran 6 - 10 of these with t1/2=24 and up (okay, 3 drugs w mean 24 hrs.)

John

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