Bioequivalence and Bioavailability Forum

Dear All,

Here with I am requesting you to clarify my doubt on the BE study retention sample.

As per USFDA, “The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application.”

Here the question is five times of the release test means, quantity required for COA or total analytical requirement?

Total analytical requirement means physical evaluation, analytical testing, disso testing, stability requirement, F2 disso profile & analytical testing for COA.

As per EMA, “ the reference sample should be of sufficient size to permit the carrying out, on, at least, two occasions, of the full analytical controls on the batch in accordance with the IMP dossier submitted for authorization to conduct the clinical trial”.

Here the same question is two occasions of the full analytical controls means, quantity required for COA or total analytical requirement?