Bioequivalence and Bioavailability Forum

❝ [...] only one measurable concentration was observed in two subjects. Shall we include the subjects in PK& Statistical Analysis?

Surprised

Is it possible to calculate the AUC with a single conc in a period??

No.

To get an AUC you may require at least three measurable concentrations in a subject per period is required.

You can consider this one as a outlier, but are the Regulatory Authorities are accept outliers???

❝ If no please provide me a guidline reference.

Refer Page 14/27 of EMEA.

Regards
Raghavender.Chenna

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]