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RegisterBlood stability testing during method validation [Bioanalytics]
Dear All,
It is recommended/required to perform the sample collection-process stability (Blood stability testing) during method validation.
The FDA Method Validation guidance states that drug stability should be proven during sample collection and handling, where the drug is still in blood form. Though EMEA draft guideline for validation has also hinted "Sufficient attention should be paid to the stability of the analyte in sampled matrix directly after blood sampling of subjects and further preparation before storage"
So what are your views on this.
Regards,
Shuja
Edit: Category changed. [Helmut]
It is recommended/required to perform the sample collection-process stability (Blood stability testing) during method validation.
The FDA Method Validation guidance states that drug stability should be proven during sample collection and handling, where the drug is still in blood form. Though EMEA draft guideline for validation has also hinted "Sufficient attention should be paid to the stability of the analyte in sampled matrix directly after blood sampling of subjects and further preparation before storage"
So what are your views on this.
Regards,
Shuja
Edit: Category changed. [Helmut]
Complete thread:
- Blood stability testing during method validationshujak1 2010-06-10 14:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IMHO an open issue Helmut 2010-06-10 15:18
- IMHO an open issue shujak1 2010-06-11 06:07
- IMHO an open issue Helmut 2010-06-11 13:50
- IMHO an open issue BPA 2010-06-11 10:21
- IMHO an open issue Ohlbe 2010-06-11 10:44
- IMHO an open issue BPA 2010-06-11 11:42
- IMHO an open issue Helmut 2010-06-11 13:41
- IMHO an open issue BPA 2010-06-11 11:42
- IMHO an open issue Ohlbe 2010-06-11 10:44
- IMHO an open issue shujak1 2010-06-11 06:07
- IMHO an open issue Helmut 2010-06-10 15:18
Ing. Helmut Schütz