Bioequivalence and Bioavailability Forum

Dear Vajra,
Thank you for the response.

I was actually looking at a situation where in analyte and metabolite/s OR 2 or more than 2 analytes are quantified simultaneously. (Difference in Tmax may or may not be less than an hour)

In such instances how will the samples be selected for each analyte/metabolite/s?

Also as per the white paper, samples need to be selected for each analyte.

If the samples are picked for each analyte, then do we look at the data for the other analyte (analyte 2) from this set also OR do we stick to ISR results from the samples actually picked for Analyte 2?

E.g: Simultaneous analysis of Stavudine and Lamivudine

Samples picked for Stavudine. ISR passes. Lamivudine results from this set of samples also to be looked into? What if it fails?

Samples picked for lamivudine. ISR passes. Stavudine results from this set of data also to be looked into? What if it fails?

Request comments on the same

Regards,
Shastri