Bioequivalence and Bioavailability Forum • IR versus MR

IR versus MR [Design Issues]

posted by gagandeep – 2007-03-29 12:58 (7019 d 04:21 ago) – Posting: # 601
Views: 5,621

Dear

I suggest you perform the study by the following method:

See the Tmax, Cmax and half-lives of the drugs
Dose the subjects with the MR and choose timepoints as per Tmax and half-life – Plot the timepoints accordingly (keep frequent timepoints near Tmax)
With the BD drug, again plan timepoints accordingly and keep them frequent near each Tmax.
Remember that the timepoints and consequently blood collection for the subjects randomized into BD dosing will be more. Hence take care not to exceed the total volume of blood collection more than your SOP’s / procedures / IRB recommendations
In case you are doing fast and fed studies and for example, if food delays Tmax or changes the slope of the graph of conc v/s time, then you may have to re-adjust timepoints of in fed study, or even add / subtract a couple timepoints.
Your statistician should be prepared well for such project.

Good luck!

Dr. Gagandeep Singh
Head – Clinical Research
BioArc (Alembic Pharma)

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