 | Nick, I might start with a piece of work that got a drug approved for a disease that, at the time was without any treatment, you may be familiar with this. http://www.pnas.org/cgi/reprint/89/23/11466.pdfand move on the the current end of phase IIa process, which is mostly focused around using modeling to select dosing regimens, and finish with a purely regulatory and marketing piece of work that I'm familiar with: http://www.aesnet.org/Visitors/AnnualMeeting/A!
bstracts/dsp_Abstract.cfm?id=2578(this got published as a real article, but I can't find a link to the paper). Mark Sale MD
Next Level Solutions, LLC
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-------- Original Message --------
Subject: Re: [NMusers] Reporting Modeling Results
From: Nick Holford <n.holford@auckland.ac.nz>
Date: Fri, October 26, 2007 6:09 pm
To: "'nmusers'" <nmusers@globomaxnm.com>
Mark,
> I don't mean - at all - to suggest the pk work done in academics (post-marketing, without
> industry or regulatory support), but I had to take exception with the assertion:
> >Regulatory and marketing are minor shadows in the big picture of using medicines to improve
> >health.
> IMHO, there are a lot of very talented people in pharm companies and regulatory agencies,
> working very hard to figure out the best way to use drugs. I think that their contributions are not
> minor shadows in figuring out how to use medicine. They are the front line in doing this, not just
> box ticking exercises.
I agree with you that there are talented PKPD people in drug companies and even at some regulatory agencies. But it is hard to discern any evidence of benefit on outcome that can be attributed to regulatory agencies and marketing activities. That is why I said regulatory and marketing are minor shadows in the big picture. If you can point to such evidence in the published literature I am willing to be educated.
Nick
--
Nick Holford, Dept Pharmacology & Clinical Pharmacology
University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New Zealand
n.holford@auckland.ac.nz tel:+64(9)373-7599x86730 fax:+64(9)373-7090
www.health.auckland.ac.nz/pharmacology/staff/nholford
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