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Norah ★ Tunisia, 2018-01-16 12:57 (3074 d 00:28 ago) Posting: # 18178 Views: 8,006 |
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Hello dears I have another question please In the case that a pharmaceutical company has it own BE center (like Apotex), how is it possible to avoid COI when performing BE studies for it's own drugs? thanks a lot Edit: Category changed; see also this post #1. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2018-01-16 13:45 (3073 d 23:39 ago) @ Norah Posting: # 18180 Views: 6,796 |
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Hi Norah, ❝ In the case that a pharmaceutical company has it own BE center (like Apotex), how is it possible to avoid COI when performing BE studies for it's own drugs? You certainly have a point! In such a case the pressure to deliver “favorable” results might be even larger than usual… — 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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Norah ★ Tunisia, 2018-01-16 14:53 (3073 d 22:31 ago) @ Helmut Posting: # 18182 Views: 6,797 |
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Exactly is there any measures to be taken to avoid to influence the results? thanks again |
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Norah ★ Tunisia, 2018-01-18 11:04 (3072 d 02:21 ago) @ Norah Posting: # 18202 Views: 6,813 |
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I know that my question is weird, but to avoid COI in a bioequivalence study conducted in a center belonging to a pharmaceutical company, I need to establish the cases of fraud (possible frauds to influence the results in favor of the pharmaceutical lab) in order to prevent them ( implement preventive actions ), can you please help me to find what are the possibilities of fraud? thank you |
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Ohlbe ★★★ France, 2018-01-18 11:27 (3072 d 01:57 ago) @ Norah Posting: # 18204 Views: 6,755 |
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Dear Norah, ❝ I need to establish the cases of fraud (possible frauds to influence the results in favor of the pharmaceutical lab) in order to prevent them ( implement preventive actions ), can you please help me to find what are the possibilities of fraud? OMG, there are so many possibilities... Have a look at some of the Untitled Letters on the FDA web site, WHO's Notices of Concern and EMA CHMP referrals, and you'll get some public examples. Google will also help you find some relevant examples, including some oldies (e.g. the generic drug scandal in the USA in the early eighties). I won't list all possibilities that I'm aware of, as I wouldn't like to give bad ideas to some people. Meanwhile, please note that most of the cases published so far involved CROs, not the sponsor's own facilities. I see your point that there is an added risk if the sponsor do their own trials, but the risk exists anyway. — Regards Ohlbe |
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Norah ★ Tunisia, 2018-01-18 11:41 (3072 d 01:43 ago) @ Ohlbe Posting: # 18206 Views: 6,664 |
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Thanks Ohlbe!! |
Ing. Helmut Schütz