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drsatishmc ☆ 2010-11-20 10:44 (5698 d 22:17 ago) Posting: # 6180 Views: 7,713 |
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Dear all Please let me know the maximum acceptable blood volume collection in a BE study - regulatory view If possible give references thanks |
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Helmut ★★★   Vienna, Austria, 2010-11-20 15:20 (5698 d 17:40 ago) @ drsatishmc Posting: # 6181 Views: 6,291 |
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Dear Satish! ❝ Please let me know the maximum acceptable blood volume collection in a BE study - regulatory view I don’t know of any regulatory requirements – the maximum blood loss is judged by the ethics committee. See also these threads: — 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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manan ☆ Ahmedabad, 2010-11-25 11:47 (5693 d 21:14 ago) @ drsatishmc Posting: # 6221 Views: 6,161 |
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Dear Satish The blood volume is usually a concern of ethics committee. 500 ml of blood is acceptable. However, it depends on the wash out between two periods as well. If the wash out is high then higher blood volume is acceptable. |
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patilatu ☆ 2010-12-17 13:17 (5671 d 19:44 ago) @ drsatishmc Posting: # 6314 Views: 6,069 |
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Dear Dr. Satish, permitted blood loss in Indian volunteers could be different. As you are aware that for a normal blood donation the Red Cross has permitted max of 350mL. In BA/BE set up around 500 mL is acceptable which includes the reserve volume of blood for evaluating safety post study (here post study is apart from the safety sample), if needed. Thanks. Patilatu. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2010-12-17 14:52 (5671 d 18:09 ago) @ patilatu Posting: # 6315 Views: 6,156 |
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Dear Patilatu! ❝ As you are aware that for a normal blood donation the Red Cross has permitted max of 350mL. Where did you get this number from? Jaime already stated in this post the volume of blood donation by the American Red Cross. See also ARC’s FAQs: Donation Process > How does the blood donation process work? > Borrowing from Jaime:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz