Bioequivalence and Bioavailability Forum

Dear Shuja
I also made the experience that auditors asked to have separate aliquots for backup purpose. They want to be on the safe side but they are wrong: Once the study report is finalized you do not need the samples anymore. If the study passed everything is fine, if the study failed you would not be allowed to do re-analysis. If the study is subject of an inspection and you still have the samples what would be the advantage? At that time the stability would have been exceeded. So my suggestion is to keep the aliquots in two different places (freezers) but under the same conditions in the clinic and later in the lab. Send the first aliquot to the lab and after it arrived safely you send the second. Keep in mind that the second aliquot is usually regarded as a back up in case of damage to the first.
Hope this helps
Dan