Bioequivalence and Bioavailability Forum

Dear Rajeep,
If you perform a confirmatory BE study you have to take samples from a production scale batch. So the sponsor should be able to provide enough retention samples. If the sponsor did not provide enough samples he has to take the consequences.....
If the sponsor fails to provide information about the in-vitro release test data you should be alerted. Does the sponsor intent to test quick and dirty a formulation without having any data? What about CoA? How do you get a positive ethics vote and/or approval from your competent regulatory authority?
The retention samples have to be stored under the same conditions as the study medication at the CRO. For an exploratory pilot study you do not have to store retention samples (I guell this is the case, right?)
I hope this helps
Kind regards
Dan