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vivekb2 ☆ India, 2017-02-20 12:12 (2851 d 01:02 ago) Posting: # 17087 Views: 5,882 |
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Ohlbe ★★★ France, 2017-02-20 12:51 (2851 d 00:22 ago) @ vivekb2 Posting: # 17090 Views: 4,916 |
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Dear Vivek, I am not aware of any retention period mentioned in any of the main BE guidelines. It is a matter of agreement between the sponsor and the CRO. Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months. In any case it makes little sense to store the samples beyond their demonstrated stability period. If they are stored for a longer duration: I would recommend to store QC samples along with them. If the samples need to be re-analysed, you can then demonstrate stability (or instability). — Regards Ohlbe |
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jag009 ★★★ NJ, 2019-04-23 19:22 (2058 d 18:52 ago) @ Ohlbe Posting: # 20211 Views: 3,363 |
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Hi Ohlbe, ❝ Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months. Do you know why some sponsors want to have their samples kept until application approved? From EMA or FDA, is there a requirement mentioned in any of the guidances? We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date. I asked my folks and their answer was "we can always ask the CRO to extended the stability"  Thanks J |
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ElMaestro ★★★ Denmark, 2019-04-23 20:15 (2058 d 17:58 ago) @ jag009 Posting: # 20212 Views: 3,368 |
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Hi jag, ❝ "we can always ask the CRO to extended the stability" "...if we stored the samples along with appropriate QC's." The thing is regulators throw a curve ball every now and then. Sometimes there is even a degree of rationale behind it. If the study is inspected or someone asks for re-analysis or any other activity of this type then you simply have much better chances of answering if you have the samples and the QCs still frozen. CRO compliance suddenly questioned by an evil inspector? Send the B-set to another CRO, show BE with those samples, and Bob's your uncle! — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2019-04-24 13:54 (2058 d 00:20 ago) @ jag009 Posting: # 20219 Views: 3,298 |
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Hi John, ❝ Do you know why some sponsors want to have their samples kept until application approved? "Because we've always done it", I guess... ❝ From EMA or FDA, is there a requirement mentioned in any of the guidances? EMA: no. FDA: not that I know of. ❝ We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date. I agree with ElMaestro: some sponsors just want to be on the safe side and only repeat the bioanalytical part rather than the whole study if the lab messed up somewhere. There was a time also when guidelines or requirements were not as clear as they can be now and an Agency would unexpectedly ask for the metabolite in addition to the parent, or similar stuff. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2019-04-24 14:22 (2057 d 23:51 ago) @ jag009 Posting: # 20220 Views: 3,302 |
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Hi John, ❝ I asked my folks and their answer was "we can always ask the CRO to extended the stability" I agree with what ElMaestro wrote. See also the end of this post. If you pay for extended storage, why not? — 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 |
Ing. Helmut Schütz