Bioequivalence and Bioavailability Forum

Dear Raghavendra,

Once again it depends on the question...

If the answer is absolutely needed before you can administer the product to the subjects (for instance the expiry date), then telling the sponsor no answer would result in postponing the trial usually helps to get a fast answer.

Whether you can already dispense/package the IMP depends on its primary packaging and on how you do the packaging yourself, I would say. If it is in a large bottle, or if you remove it from its blister: this is usually done on the day before dosing, for stability reasons. So if you're not sure to be able to dose, doing the dispensing/packaging may be a problem. If the IMP remains in its blister, then no problem to do the dispensing/packaging in advance.

Regards
Ohlbe