10-07-2010, 04:57 PM
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#19 (permalink)
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Quote:
Originally Posted by Wes Mantooth
Yeah I don't really know the inner workings of the pharmaceutical industry very well, I think I got that from some documentary I saw years ago talking about how it wasn't uncommon for large pharmaceutical companies to "bypass" the system to keep the market flooded and keep profits up...although it may have just been a very biased misrepresentation. I do wonder why it seems like so many prescription drugs seem to be getting recalled due to bad side effects though, there might be something to it I suppose lazy testing could account for that.
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continuing OT.....
this should give you a pretty good idea of what is involved
http://www.jabfm.org/cgi/reprint/14/5/362.pdf
Quote:
Drug Development
Drug development can generally be divided into
phases. The first is the preclinical phase, which
usually takes 3 to 4 years to complete. If successful,
this phase is followed by an application to the FDA
as an investigational newdrug (IND). After an
IND is approved, the next steps are clinical phases
1, 2, and 3, which require approximately 1, 2, and 3
years, respectively, for completion (Table 1). Importantly,
throughout this process the FDA and
investigators leading the trials communicate with
each other so that such issues as safety are monitored.
The manufacturer then files a newdrug
application (NDA) with the FDA for approval.
This application can either be approved or rejected,
or the FDA might request further study before
making a decision. Following acceptance, the FDA
can also request that the manufacturer conduct
additional postmarketing studies. Overall, this entire
process, on average, takes between 8 to 12
years.2 Figure 1 summarizes the drug approval process.
It is not surprising that from conception to market
most compounds face an uphill battle to become
an approved drug. For approximately every
5,000 to 10,000 compounds that enter preclinical
testing, only one is approved for marketing.8 A
1993 report by the Congressional Office of Technology
Assessment estimated the cost of developing
a newdrug to be $359 million.9 Newer figures
place the cost at more than $500 million.10
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Done with that, now who has one for me to light up?  |
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