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]

Dear Kiran,

before the PK analysis there is lot to do. first investigation has to be carried out for the possible cause both in clinic and bio analytical stage.
as the subject cant be removed form the PK analysis with out the proper justification for the with drawl from analysis.

when come to inclusion of the subject in to PK with one concentration point, i don't think it worth full.

one more thing if it is in the test formulation then it will be serious issue, as per my knowledge.

please correct me if i am wrong.

Dear all
If the measured concentration occurs at tmax the drug might have a large inter-subject variability. In this case your bioanalytical method might not be sensitiv enough.
Kind regards
Dan