Bioequivalence and Bioavailability Forum

Hello Varsha,

I think your finding is quite out of the ordinary and interesting, and not necessarily alarming.
I assume and hope all AEs have resolved.

I would definitely look into this. Visit the lab, be physically present, open books, check data, instruments/calibrations and whodunnit. Look into your own records to check if you have subjects in other trials analysed for ESR in the same timeframe, and review their ESR's as well. And ask if other trials recently have been associated with weird ESR issues (which they might not be willing to share with you).