Bioequivalence and Bioavailability Forum

Dear HS,

Thanks for your reply.

FDA suggests that if half-life is greater than 24 hours study can be truncated for 72 hrs. But in EU there is no cut off value like FDA. It suggests "A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug."

In the current study the half-life is 23 hrs. If we take 5 half-life's to complete sampling schedule it takes up to 120 hrs. But as per the EU longer than 72 is not required for immediate release formulations. Hence Can we consider truncation in this case?

Please suggest me