Bioequivalence and Bioavailability Forum

Hi valivetiananth,

❝ We are planning a Nicotine Lozenges BE study. In that study is there any necessary to measure carbon monoxide levels?

In my opinion CO isn't necessary. CO is a potential safety marker for innovators when the formulations are new. In case of BE -and if this BE study is not for a line extension- the need for CO measurement as endpoint isn't that clear.
Of course, should a volunteer experience an SAE and turn red during the trial it might very well be a good idea to have access to a CO assay (as well as a good lawyer).