Bioequivalence and Bioavailability Forum

Hi Kaushik089,

❝ We are planning to conduct a pharmacoscintigraphy study in mesalamine 1.2gm tab were technetium Tc99m for radiolabelling .Our ethics committee raising concerns on percentage of radiation given to trial subjects. As per our radiologist opinion we are planning to give 500±200 microcurie which is a very less radiation limit, but our IEC asking to produce a literature behind radiation limits to humans so i want to know is there any guidelines for radiology for conducting pharmacoscintigraphy studies? i have Googled but couldn't find any?

If I am not mistaking 500 microcurie amounts to 18.5 MBq. You did not really specify many details about how the labeling is being done, but try and have a look at the website of the American College of Radiology, in particular their best practice paper on GI imaging. Depending on your setup 18.5 MBq might not appear that frightening as long as children are not involved.