EMA: AUC72 for all IR products [General Sta­tis­tics]

posted by pmohite – India, 2020-06-24 12:08  – Posting: # 21573
Views: 668


The Revised EMA Bioequivalence Guideline, Questions & Answers, Summary of the discussions held at the 3rd 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 AUCt and AUC72 is acceptable as long as the sampling period allows for an adequate characterisation of AUCt. 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.


Edit: Document linked. [Helmut]

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