Log in
Register|
alagu ☆ India, 2013-08-20 15:00 (4690 d 17:23 ago) Posting: # 11316 Views: 4,151 |
|
|
After finishing bio-analysis for Pivotal BE study Aliquot 2 storage time period required for USA & EUROPE market? |
|
Ohlbe ★★★ France, 2013-08-20 15:51 (4690 d 16:32 ago) @ alagu Posting: # 11319 Views: 3,613 |
|
|
Dear Alagu, First please read the Forum policy, particularly under 'search' and 'be polite'. ❝ After finishing bio-analysis for Pivotal BE study Aliquot 2 storage time period required for USA & EUROPE market? Europe: nothing mentioned in any guideline. There is no requirement to keep the samples for any period of time after the end of the trial. It would make no sense to keep the samples if you don't have long-term stability data to support their use anyway. US: AFAIK, no requirement either. Some sponsors require the lab to keep the samples until the product gets approved, in case they get a query from regulatory agencies e.g. to analyse a metabolite in addition to the parent, etc. — Regards Ohlbe |
|
jag009 ★★★ NJ, 2013-08-20 20:10 (4690 d 12:12 ago) @ Ohlbe Posting: # 11324 Views: 3,585 |
|
|
Hi Ohlbe, Also depending on the long term stability, no? John |
|
Ohlbe ★★★ France, 2013-08-20 21:16 (4690 d 11:07 ago) @ jag009 Posting: # 11328 Views: 3,598 |
|
|
Hi John, Yes, that's what I wrote in my post: it makes little sense to keep the samples if you don't have the long-term stability data to back this up. A solution could be to also keep QC samples along with the study samples, to be able to check the long-term stability in case you need some re-analysis. But this won't help if you have to re-analyse the samples for another analyte such as a metabolite. Most CROs charge for sample storage after 3 to 6 months, which usually makes sponsors reconsider their "just-in-case" attitude  — Regards Ohlbe |
|
jag009 ★★★ NJ, 2013-08-20 21:51 (4690 d 10:32 ago) @ Ohlbe Posting: # 11329 Views: 3,607 |
|
|
Thanks Ohlbe, ❝ A solution could be to also keep QC samples along with the study samples, to be able to check the long-term stability in case you need some re-analysis. But this won't help if you have to re-analyse the samples for another analyte such as a metabolite. I have a question. If somewhere down the road someone wants to analyze the samples beyond long term stability, is it possible? For research purposes, not regulatory. It is doable to extend the long term stability right? Thanks John |
|
Ohlbe ★★★ France, 2013-08-21 12:07 (4689 d 20:15 ago) @ jag009 Posting: # 11331 Views: 3,522 |
|
|
Hi John, ❝ I have a question. If somewhere down the road someone wants to analyze the samples beyond long term stability, is it possible? For research purposes, not regulatory. It is doable to extend the long term stability right? Sure, it is. It just takes time, that's all If you still have old QC samples, that's quite easy. If you don't: well, you'll have to prepare stability samples, analyse your study samples, and wait for your stability samples to become old enough... If you still aim for the same analyte, and if it's only for research purposes, you can also just compare the new results to the old ones. If you still find the same result, the samples were (probably) stable. If the result is systematically lower, either the analyte was not stable, or you screwed up somewhere. If the result is systematically higher, either an unstable metabolite got back-converted, or you screwed up somewhere If you go for a new analyte (metabolite, etc.), first check what information was given to the subjects in the informed consent form. You may have to re-consent them first ! — Regards Ohlbe |
Ing. Helmut Schütz