Norah
★    

Tunisia,
2018-01-16 12:57
(2339 d 23:31 ago)

Posting: # 18178
Views: 4,838
 

 Conflict of interest [GxP / QC / QA]

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]
Helmut
★★★
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Vienna, Austria,
2018-01-16 13:45
(2339 d 22:43 ago)

@ Norah
Posting: # 18180
Views: 4,170
 

 Conflict of interest

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…

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Norah
★    

Tunisia,
2018-01-16 14:53
(2339 d 21:34 ago)

@ Helmut
Posting: # 18182
Views: 4,149
 

 Conflict of interest

Exactly
is there any measures to be taken to avoid to influence the results?
thanks again
Norah
★    

Tunisia,
2018-01-18 11:04
(2338 d 01:24 ago)

@ Norah
Posting: # 18202
Views: 4,181
 

 Conflict of interest

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
Ohlbe
★★★

France,
2018-01-18 11:27
(2338 d 01:00 ago)

@ Norah
Posting: # 18204
Views: 4,164
 

 Fraud

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
Norah
★    

Tunisia,
2018-01-18 11:41
(2338 d 00:46 ago)

@ Ohlbe
Posting: # 18206
Views: 4,049
 

 Fraud

Thanks Ohlbe!!
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