Bioequivalence and Bioavailability Forum

Hi Noha,

❝ Is it okay to enroll volunteers with slightly high or slightly low platelet count in a bioequivalence study?

Your protocol may not explicitly state that platelet count has to be within xx - yy. In that case the PI or other MD who has been delegated the task may judge that the count is not clinically significant and the volunteer is therefore still healthy and normal and qualifying for enrollment. This should be per SOP; if you don't have a SOP for this then I'd play it safe and not enroll such subjects.

Dear Noha,

All the hematology values needs to be corelated clinically with the subject. A physician can determine if the values are clinically significant or nil significant. If the values are clinically nil significant you can enroll the subject for the study.

Regards
P.S.Srinivas