Keath
☆    

India,
2014-03-24 11:00
(4480 d 21:02 ago)

Posting: # 12693
Views: 4,404
 

 Plasma sample storage duration from USFDA per­spective [Regulatives / Guidelines]

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Dear All,

I have a query about the plasma sample storage duration at the CRO after successful completion of the Pivotal BE study.
  1. Can somebody tell me is there any perticular time duration to which it is mandatory to store the plasma samples as per FDA requirements?

  2. If it is mandatory to store the plasma samples, Is there perticular time period for retenetion of plasma samples after that we can discard irrespective of FDA's approval for that product?

  3. what would be the possibilities that FDA will ask for the physical availability of plasma sample for reanalysis?

Thank you in Advance

Keath
 
Helmut
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Vienna, Austria,
2014-03-24 18:10
(4480 d 13:52 ago)

@ Keath
Posting: # 12695
Views: 3,752
 

 Plasma sample storage duration from USFDA per­spective

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Dear Keath,

please [image] search the forum in the future.
There are no regulatory requirements published by the FDA (and EMA as well). Going beyond the validated long-term storage is of limited value. However, we kept complete samples of one subject for infinite time as some kind of proof that the study was not fabricated. ;-)
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Keath
☆    

India,
2014-03-25 06:05
(4480 d 01:57 ago)

@ Helmut
Posting: # 12697
Views: 3,660
 

 Plasma sample storage duration from USFDA per­spective

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Dear Helmut,

Thank you for your response to my query.

Keath
 
AngusMcLean
★★  

USA,
2014-03-26 21:26
(4478 d 10:37 ago)

@ Keath
Posting: # 12720
Views: 3,634
 

 Plasma sample storage duration from USFDA per­spective

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Keath: One thing that I would recommend is to store spiked samples of known concentration in the range of concentration of your clinical samples together with the clinical samples. You can use these samples to validate the stability of drug in plasma.


Angus
 
Keath
☆    

India,
2014-03-27 06:18
(4478 d 01:44 ago)

@ AngusMcLean
Posting: # 12721
Views: 3,655
 

 Plasma sample storage duration from USFDA per­spective

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Dear Angus

Thank you for sharing your views on this matter.

Just want to confirm that we can store only QC samples for stability purpose right? we dont require to store all the plasma samples of each subjects, is it so?

Keath
 
Ohlbe
★★★

France,
2014-03-27 11:35
(4477 d 20:27 ago)

@ Keath
Posting: # 12724
Views: 3,677
 

 Plasma sample storage duration from USFDA per­spective

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Dear Keath,

❝ Just want to confirm that we can store only QC samples for stability purpose right? we dont require to store all the plasma samples of each subjects, is it so?


No. The idea is that if you decide to keep the study samples, you should also keep QC samples along with them. This way you will be able to extend your stability data, in case you need to reanalyse the study samples.
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Regards
Ohlbe
 
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