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bkrao ☆ India, 2015-08-10 09:24 (3971 d 10:34 ago) Posting: # 15200 Views: 6,847 |
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Hi, Is there is any restriction that the bioanalytical department should not be accessable to randomization schedule? If so, please let me know the source guidelines. My exact intention is whether the person who knows the randomization schedule can be able to perform the bioanalytical activities also? Is there any regulatory violation.?Kindly clarify. If so, then let me know the respective guidance with respect to the same provison. I hope randomization shcdule must be blinded to the bioanalytical department before bio analysis to avoid the bias. I egarly awaited for your valubale suggestions. Thanks & Regards, Balaga Koteswara Rao. Cadila Pharmaceuticals Ltd. |
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BE-proff ● 2015-08-10 10:38 (3971 d 09:20 ago) @ bkrao Posting: # 15201 Views: 5,899 |
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Hi,Balaga I have seen a lot of reports done by European laboratories. All of them contain PK and concentration data along with randomization codes  All these labs have been audited and inspected so that they hardy violate anything. |
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bkrao ☆ India, 2015-08-10 10:51 (3971 d 09:07 ago) @ BE-proff Posting: # 15204 Views: 5,958 |
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Thanks you dear. My question is whether the treatment randomization is accessable to the bioanalytical persons before the intioation of the bioanalytial phase. Thanks & Regards, Balaga Koteswara Rao, Cadila Pharmaceutical Ltd. |
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BE-proff ● 2015-08-10 11:41 (3971 d 08:17 ago) @ bkrao Posting: # 15207 Views: 5,893 |
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Hi again, I think yes but anyway ask a laboratory if randomization info is to be sent before analytical phase (possible compliance with lab SOPs) |
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ElMaestro ★★★ Denmark, 2015-08-10 11:51 (3971 d 08:07 ago) @ bkrao Posting: # 15208 Views: 5,881 |
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Hi bkrao, ❝ My question is whether the treatment randomization is accessable to the bioanalytical persons before the intioation of the bioanalytial phase. Usually, BE studies are open-label and control of the rand. code is thus not extremely crucial, but it is a good habit in the industry to keep the rand. code away from bioanalysts. Most companies I know of state that bioanalysts are actually kept blind, both in protocols and SOPs. I think this is a very healthy principle but it is not specifically regulated by a guideline. — Pass or fail! ElMaestro |
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bkrao ☆ India, 2015-08-10 12:18 (3971 d 07:39 ago) @ ElMaestro Posting: # 15209 Views: 5,912 |
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Thanks you. I required few more suggestions in this regard. If analyst knows the treatment received by the subject, then the analysis bias is open thing know? Then the study will be a result oriented, analyst driven study, we can call. but its should not be actual outcome required by the regulatory i hope, kindly suggest. Thanks you & Regards, Balaga Koteswara Rao, Cadila Pharmaceuticals Ltd. |
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ElMaestro ★★★ Denmark, 2015-08-10 12:53 (3971 d 07:05 ago) @ bkrao Posting: # 15210 Views: 5,834 |
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Hi Mr. Rao, now you sound like a banker or a LEAN consultant  I don't know how those terms fit into the realm of regulated BE. Why would a bioanalyst have access to the rand. code after all? I think there should be a reason; preferably a better reason than just convenience. Of course, from a regulatory side there might arise a bit of fear that knowledge pf the rand. code could be used inappropriately somehow: As far as I can tell a bioanalyst knowing the rand. code can use that knowledge inappropriately during the analysis phase (without going into detail, mind you), and coversely I don't see how the knowledge can be used in a good fashion. If you ever find yourself in a situation where people question the integrity of a study then you are better off if you can demonstrate that the QMS is mature and that the rand. code is not accessible or accessed until the day of stats. — Pass or fail! ElMaestro |
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bkrao ☆ India, 2015-08-10 15:22 (3971 d 04:36 ago) @ ElMaestro Posting: # 15213 Views: 5,854 |
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Please respond any one, Whether the the person who involved in the clinical phase of the study is able to involve in the bioanalytical phase also? If so, then what about the compliance to the treatment blinding condition? |
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Helmut ★★★   Vienna, Austria, 2015-08-10 20:33 (3970 d 23:25 ago) @ bkrao Posting: # 15214 Views: 5,760 |
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Hi Balaga, ❝ Please respond any one, Such an “ASAP” attitude sends me into a deep slumber. We are posting in our free time here… ❝ Whether the the person who involved in the clinical phase of the study is able to involve in the bioanalytical phase also? If so, then what about the compliance to the treatment blinding condition? Can you give an example? A study nurse doing liquid-liquid extraction? One of my stories. We had to deal with a very sensitive drug and stabilization was a tricky procedure. We decided not to leave it on the shoulders of the clinical staff but opted for one of our bioanalysts. To avoid troubles with breaking the blind, we also decided that this analyst was not part of the team working in the analytical phase later on. But: You never can proof to an inspector that this guy is not an idiot savant who easily memorizes a three page random list and tell it to his colleagues later. — 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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bkrao ☆ India, 2015-08-11 07:44 (3970 d 12:14 ago) @ Helmut Posting: # 15221 Views: 5,743 |
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Really Sorry dear Helmut for the term "ASAP".... i understood your busy schedule. Thanks a lot for your valuable suggestion. |
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Ohlbe ★★★ France, 2015-08-17 20:14 (3963 d 23:44 ago) @ bkrao Posting: # 15287 Views: 5,548 |
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Dear Balaga, ❝ Is there is any restriction that the bioanalytical department should not be accessable to randomization schedule? If so, please let me know the source guidelines. EMA BE guideline, § 4.1.7, last line: Analysis of samples should be conducted without information on treatment. — Regards Ohlbe |
Ing. Helmut Schütz