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manojkarwa ☆  New Delhi, 2009-02-10 07:35 (6348 d 09:01 ago) Posting: # 3216 Views: 3,237 |
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What is the guidelines for discarding plasma samples after completion of BA/BE study and how it should be documented — Manoj Karwa, Project Manager, Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi-110015 Phone 011-45072314 |
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Helmut ★★★  Vienna, Austria, 2009-02-10 12:24 (6348 d 04:12 ago) @ manojkarwa Posting: # 3218 Views: 2,648 |
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Dear Manoj, first of all: 1, 2, and 3 - where 1 is mandatory and the order of 2 and 3 may be changed.  — 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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manojkarwa ☆ New Delhi, 2009-02-14 05:44 (6344 d 10:52 ago) (edited on 2009-02-14 11:27) @ Helmut Posting: # 3236 Views: 2,508 |
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Dear Helmut, I am really sorry that i have not followed the forum etiquette but that was not my intention. I apologize for the same and assure you that this will not be repeated from my side. Now i request the forum member to guide me on procedure of discarding of plasma samples after completion of any BA/BE study. Regards Manoj Karwa -- Edit: Full quote removed. Please see this post! [Jaime] — Manoj Karwa, Project Manager, Auriga Research Limited, 3/15, Kirti Nagar Industrial Area, New Delhi-110015 Phone 011-45072314 |
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Ohlbe ★★★ France, 2009-02-14 17:32 (6343 d 23:04 ago) @ manojkarwa Posting: # 3241 Views: 2,458 |
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Dear Manoj, No guideline in this field. No use keeping plasma samples for an extended period of time if you have no long-term stability data... The usual practice is to keep the samples at least until the final report is accepted by the sponsor. After that... it depends on what you have in the contract with the sponsor. Some sponsors ask for the samples to be kept until the study is approved by whichever Agency they have submitted it to. What I quite often see is that samples are kept for 6 months after the end of the trial, then destroyed. If the sponsor wants the samples to be kept for a longer period of time, they get charged for it, or they have them shipped to them. But once again this is not covered by any guideline, at least in EU or US. Regards Ohlbe |
Ing. Helmut Schütz