Bioequivalence and Bioavailability Forum

Dear Tina
First of all a placebo is a drug without active ingredient intended to be administered to humans. Therefore you need to ensure, that (like a drug with active ingredient) the excipients are safe (TSE/BSE certificates) and do not alter within the time intended for the clinical conduct. For studies to be conducted in the EU you consequently need an IMPD also for the placebo. However, dissolution or disintegration tests will not be required.
In a second step you have to think about:
- is the study open, single-blinded or blinded?
- is it a parallel or cross-over design?
in order to evaluate if you really need a placebo that exactly matches (shape, weight, colour) the comparitor or if you could use a commercially available placebo which would make the preparation of the IMPD much easier.
I hope this helps.
Kind regards
Dan