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Ohlbe ★★★ France, 2015-10-11 13:35 (3514 d 06:26 ago) Posting: # 15549 Views: 7,064 |
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Dear all, Health Canada have published a clarification on the stability experiments in matrix. Basically: the results should be generated from independent aliquots, not from replicate measurements of a single aliquot. — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2015-10-12 00:08 (3513 d 19:53 ago) @ Ohlbe Posting: # 15552 Views: 5,907 |
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Hi Ohlbe, thanks. 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? — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2015-10-12 00:34 (3513 d 19:27 ago) @ ElMaestro Posting: # 15553 Views: 5,920 |
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Dear ElMaestro, ❝ 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 |
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nobody nothing 2015-10-13 13:56 (3512 d 06:05 ago) @ Ohlbe Posting: # 15554 Views: 5,812 |
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@Ohlbe, makes perfectly sense to me, to store the samples in separate aliquots (as the clinical samples), but prepared from one stock sample (simple spike), so no additional source of variation is added. — Kindest regards, nobody |
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Helmut ★★★   Vienna, Austria, 2015-10-13 17:18 (3512 d 02:42 ago) @ nobody Posting: # 15555 Views: 5,780 |
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Hi nobody, ❝ @Ohlbe, makes perfectly sense to me, to store the samples in separate aliquots (as the clinical samples), but prepared from one stock sample (simple spike), so no additional source of variation is added. Exactly. To name some good reasons:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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