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Melkor ☆ Greece, 2013-10-31 12:33 (4618 d 19:18 ago) Posting: # 11837 Views: 5,211 |
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Dear all, Could anyone inform me if there is a specific time frame that blood samples have to be stored after the completion of a BE study?  Is this refered to ICH GCP? Thank you. |
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Helmut ★★★   Vienna, Austria, 2013-10-31 16:30 (4618 d 15:22 ago) @ Melkor Posting: # 11843 Views: 4,320 |
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Hi Melkor, ❝ Could anyone inform me if there is a specific time frame that blood samples have to be stored after the completion of a BE study? Not that I recall. ❝ Is this refered to ICH GCP? No (did you read it?). CROs have different policies about storage periods:
— 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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Melkor ☆ Greece, 2013-10-31 16:51 (4618 d 15:01 ago) @ Helmut Posting: # 11844 Views: 4,255 |
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Thanks for the reply.  That's what i expected since i did read the ICH GCP but there was no clear statement for sample storage period. Nevertheless, i guess that there is no serious need to store the blood samples more than the free-of-charge period of each CRO. Possibilities for demand of re-analysis are minimized by the recent ISR except from specific occasions... Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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jalgorta ☆ Spain, 2015-08-03 19:53 (3977 d 12:59 ago) @ Melkor Posting: # 15181 Views: 3,290 |
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Dear Melkor, I have exactly the same question. Two years later, do you have new information on the need of plasma samples storage? To my personal understanding, is lack of sense mainly considering the short stability in plasma of some drugs, even at -70º. Thanks, Jaime |
Ing. Helmut Schütz