Bioequivalence and Bioavailability Forum

Hi

Does anyone know whether a change in a preservative system for an oral liquid suspension during development necessitates a repeat BE study.

So for example, if we develop an oral suspension (test) which is shown to be beioequivalent to a tablet (reference), however we decide to change the preservative in the formulation (e.g. sorbic acid to parabens) for the formulation to be marketed, will we need to repeat the BE study?

If you can point me to some regulatory FDA/EMEA guidances too, I would be very grateful.

best wishes

Hussain