Bioequivalence and Bioavailability Forum

Hello Varsha,

❝ We have conducted one BA BE study where at the time of screening, the volunteers were having normal ESR values but the post study safety reports after the drug administration reveals increase clinically significant ESR values and were considered as adverse event for nearly 18 subjects out of 48 subjects. The physician has documented the AE as not related to the drug as there is not linerature evidence for the same.

Very unusual, it falls outside any ordinary routine, I would say. No idea what the answer really is in the absense of more info about the drug identity.

Let's hear what drug this is. Makes it easier to guesswork a little.
In addition:
Was ESR measured in-house or out?
Did you review the ESR measurements where it took place?
Anything else out of the ordinary in the trial?
Did you see it in true quanta in both T and R?
(If the occurence was mainly in either T or R: measure potency of the drugs from the retention samples, consider a call to your local regulator)

❝ My concern is, is the documentation correct? What may be the reason for increase of ESR values for all these subjects.

Well, sooner or later one could say the staff should become suspicious (meaning kind of: not related could become possibly related if or when a new side effect is discovered). No idea how to define what that point in time comes.
Am eager to hear other opinions...