Bioequivalence and Bioavailability Forum

Dear VM
usually you perform a clinical study in order to make a statement about the efficacy, the safety, the bioavailability etc. of the tested product. For this you definitely need to know the quality of the product. In your case you just need plasma samples in order to develop a bioanalytical method and there is no gain in knowledge about the drug. That's why I think that a CoA is not of that importance. Nevertheless it is always better to proof the assay content of the drug and if you use the data to describe the pharmacokinetics of the reference product in order to plan a BE study it would be better to have a CoA.
I hope this helps.
Kind regards
Dan