Retention of clinical biosamples / blank matrices [Regulatives / Guidelines]

posted by Ohlbe – France, 2017-02-20 11:51  – Posting: # 17090
Views: 1,920

Dear Vivek,

I am not aware of any retention period mentioned in any of the main BE guidelines. It is a matter of agreement between the sponsor and the CRO.

Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months.

In any case it makes little sense to store the samples beyond their demonstrated stability period. If they are stored for a longer duration: I would recommend to store QC samples along with them. If the samples need to be re-analysed, you can then demonstrate stability (or instability).

Regards
Ohlbe

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,514 posts in 4,141 threads, 1,336 registered users;
online 10 (0 registered, 10 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 20:55 CEST

I have not failed 700 times. I have not failed once.
I have succeeded in proving
that those 700 ways will not work.    Thomas Alva Edison

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5