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Back to the forum  Query: 2018-02-22 04:08 CET (UTC+1h)

How to calculate this assumption...if AUCt is at least 80% of AUC∞... [Design Issues]

posted by javier - Spain, 2017-03-28 23:21  - Posting: # 17196
Views: 1,503

Dear All

First and foremost, I have been looking for a while in older post regarding this question, but although i have found some ideas, i dont have the main picture, so i kindly ask you to ilustrate all the beginners like me that we look here for enlightment

Regarding Bioequivalence studies on drugs with long half life, for example monoclonal antibodies or filgastrim,etc.... guidelines EMA and FDA says "AUCt will be ok if it is at least 80% of AUC∞."

the big question is how to calculate the amount of time to reach this conclussion about AUCt is at least 80% if you only have the information of the SmPC? (with so many important PK information omited ;-))

on another way: how to forecast the number of days that you will need to takes blood samples to cover the magic number of 80%?

in other post i have read that 2-4 times Tmax will be enought as a thumb rule, but if we are talking about intravenous infusion and long half life 's drugs i dont know if this rule will be applicable in this case or not

Thanks in advance for your time and if you ask me for the existence of this forum. I think a bebac book with all the information contained in the forum would be top list in amazon for a while..

Best regards


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