Bioequivalence and Bioavailability Forum

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.