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RegisterStorage Temperature for Plasma Samples [Bioanalytics]
Dear Group Members,
Why do we need to store plasma samples of bioequivalence studies below -70 degrees? Is the storage temperature stated in any of the guidelines?
Besides the stability of the drug & deactivation of enzymes in plasma, is there any other specific reason for storage below -70 degrees?
Which is the optimum temperature to be used for storage of plasma samples -60 or -70 or -80 degrees?
Some CRO's are storing samples even at -20 degrees, based on literature survey. Is this acceptable from regulatory point of view?
Thanks & regards,
Dr. Harish L. Rao
Why do we need to store plasma samples of bioequivalence studies below -70 degrees? Is the storage temperature stated in any of the guidelines?
Besides the stability of the drug & deactivation of enzymes in plasma, is there any other specific reason for storage below -70 degrees?
Which is the optimum temperature to be used for storage of plasma samples -60 or -70 or -80 degrees?
Some CRO's are storing samples even at -20 degrees, based on literature survey. Is this acceptable from regulatory point of view?
Thanks & regards,
Dr. Harish L. Rao
Complete thread:
- Storage Temperature for Plasma SamplesDr. Harish L. Rao 2007-10-12 09:32
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Storage Temperature for Plasma Samples Rajdeep 2007-10-13 08:15
- Storage Temperature for Plasma Samples Helmut 2007-10-13 15:40
Ing. Helmut Schütz