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RegisterISR of an unstable drug [Bioanalytics]
Dear Xipei,
As you have said, ISR should be performed within the stability period of the drug. This means that the stability period of the drug starts right from the time of first sample collection. For this you have have proven data handy regarding the stability of the sample. As in your case this is only 01 month it would be better if you start early. Even though the stability test is still going on, remember "A bird at hand is worth two in the bush". Imagine the consequence if the stability fails!!!
Now as per your question there is not other option but to perform ISR even though thsi means only 2~4 samples each batch. There is absolutely nothing wrong with this but it is suggested that the ISR of samples be performed on a different day but within the proven stability duration (See EMEA BMV Sec 6:It is therefore recommended to evaluate accuracy of incurred samples by reanalysis of study samples in separate runs at different days).
IMHO adding the ISR samples in the next batch of the unknown ones would not be considered as a good option.
Regards
P.S.Srinivas
As you have said, ISR should be performed within the stability period of the drug. This means that the stability period of the drug starts right from the time of first sample collection. For this you have have proven data handy regarding the stability of the sample. As in your case this is only 01 month it would be better if you start early. Even though the stability test is still going on, remember "A bird at hand is worth two in the bush". Imagine the consequence if the stability fails!!!
Now as per your question there is not other option but to perform ISR even though thsi means only 2~4 samples each batch. There is absolutely nothing wrong with this but it is suggested that the ISR of samples be performed on a different day but within the proven stability duration (See EMEA BMV Sec 6:It is therefore recommended to evaluate accuracy of incurred samples by reanalysis of study samples in separate runs at different days).
IMHO adding the ISR samples in the next batch of the unknown ones would not be considered as a good option.
Regards
P.S.Srinivas
Complete thread:
- ISR of an unstable drug wxp 2013-10-17 15:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ISR of an unstable drugsarada06884 2013-10-18 07:49
- ISR of an unstable drug wxp 2013-10-18 09:02
- ISR of an unstable drug Ohlbe 2013-10-18 14:39
- ISR of an unstable drug wxp 2013-10-21 04:15
- ISR of an unstable drug sarada06884 2013-10-21 11:55
- ISR of an unstable drug Ohlbe 2013-10-21 12:01
- ISR of an unstable drugsarada06884 2013-10-18 07:49
Ing. Helmut Schütz