Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-05-27 19:24 CEST (UTC+2h)
 
vivekb2
Junior

India,
2017-02-20 11:12

Posting: # 17087
Views: 628
 

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

Please suggest for Retention period of (HUMAN) clinical biosamples / blank matrices.
Regards
Vivek
Ohlbe
Hero

France,
2017-02-20 11:51

@ vivekb2
Posting: # 17090
Views: 534
 

 Retention of clinical biosamples / blank matrices

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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
16,926 Posts in 3,627 Threads, 1,029 registered users;
18 users online (0 registered, 18 guests).

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.    Stephen Senn

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed