Bioequivalence and Bioavailability Forum

Hello,

The Revised EMA Bioequivalence Guideline, Questions & Answers, Summary of the discussions held at the 3^rd EGA Symposium on Bioequivalence, June 2010, London, Session 3 under question 12 states as follows:

In studies with a sampling period of 72 h, and where the concentration at 72 h is quantifiable, AUC_(0-∞) and residual area do not need to be reported; it is sufficient to report AUC truncated at 72h, AUC_(0-72h). A mixture of AUC_t and AUC₇₂ is acceptable as long as the sampling period allows for an adequate characterisation of AUC_t. Of course, in the event samples were absent because of protocol violations on a mass scale then this would affect the acceptability of the study.

If there are around 25% of subjects missed this interval, then this will raise the acceptance of study.

Regards.

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Edit: Document linked. [Helmut]