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RegisterPlasma sample storage duration from USFDA perspective [Regulatives / Guidelines]
Dear All,
I have a query about the plasma sample storage duration at the CRO after successful completion of the Pivotal BE study.
Thank you in Advance
Keath
I have a query about the plasma sample storage duration at the CRO after successful completion of the Pivotal BE study.
- Can somebody tell me is there any perticular time duration to which it is mandatory to store the plasma samples as per FDA requirements?
- 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?
- what would be the possibilities that FDA will ask for the physical availability of plasma sample for reanalysis?
Thank you in Advance
Keath
Complete thread:
- Plasma sample storage duration from USFDA perspectiveKeath 2014-03-24 10:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Plasma sample storage duration from USFDA perspective Helmut 2014-03-24 17:10
- Plasma sample storage duration from USFDA perspective Keath 2014-03-25 05:05
- Plasma sample storage duration from USFDA perspective AngusMcLean 2014-03-26 20:26
- Plasma sample storage duration from USFDA perspective Keath 2014-03-27 05:18
- Plasma sample storage duration from USFDA perspective Ohlbe 2014-03-27 10:35
- Plasma sample storage duration from USFDA perspective Keath 2014-03-27 05:18
- Plasma sample storage duration from USFDA perspective Helmut 2014-03-24 17:10
Ing. Helmut Schütz