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RegisterBMV: Health Canada clarification on stabs [Bioanalytics]
Dear ElMaestro,
I would say no. They say that
[...] it provides limited (i.e., N = 1) information regarding the effects of the storage conditions on accuracy and no information on the effects of the conditions on the variability of the drug concentration.
Having n preparations from n spiking solutions would only add the variability of the preparation, not information on the effects of the storage condition.
They also later say regarding insufficient data that
In these cases, an amendment to the validation report will be requested that includes stability experiments conducted using sets of low and high QC samples aliquoted prior to the stability experiment and all samples subjected to the given stability conditions independently prior to processing.
My understanding is 1 aliquot from each of n tubes from the same bulk spiking (but not n aliquots taken from a single tube after thawing the stability sample).
❝ Am I right in thinking the implication is that n indepently prepared spiking (parent) solutions need to be produced if we want n replicates of the experiment?
I would say no. They say that
[...] it provides limited (i.e., N = 1) information regarding the effects of the storage conditions on accuracy and no information on the effects of the conditions on the variability of the drug concentration.
Having n preparations from n spiking solutions would only add the variability of the preparation, not information on the effects of the storage condition.
They also later say regarding insufficient data that
In these cases, an amendment to the validation report will be requested that includes stability experiments conducted using sets of low and high QC samples aliquoted prior to the stability experiment and all samples subjected to the given stability conditions independently prior to processing.
My understanding is 1 aliquot from each of n tubes from the same bulk spiking (but not n aliquots taken from a single tube after thawing the stability sample).
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BMV: Health Canada clarification on stabs Ohlbe 2015-10-11 11:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BMV: Health Canada clarification on stabs ElMaestro 2015-10-11 22:08
- BMV: Health Canada clarification on stabsOhlbe 2015-10-11 22:34
- BMV: Health Canada clarification on stabs nobody 2015-10-13 11:56
- BMV: Health Canada clarification on stabs Helmut 2015-10-13 15:18
- BMV: Health Canada clarification on stabs nobody 2015-10-13 11:56
- BMV: Health Canada clarification on stabsOhlbe 2015-10-11 22:34
- BMV: Health Canada clarification on stabs ElMaestro 2015-10-11 22:08
Ing. Helmut Schütz