Re: [NMusers] Reporting Modeling Results

Mark,

I can't see how these examples show any influence of regulatory agencies or marketing on outcome. Can you explain in each case why you think this is so?

Nick


I wrote:
>
> 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.

You replied:
> 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.pdf
>
> and 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).

--
Nick Holford, Dept Pharmacology & Clinical Pharmacology
University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New Zealand
n.holford_at_auckland.ac.nz tel:+64(9)373-7599x86730 fax:+64(9)373-7090
www.health.auckland.ac.nz/pharmacology/staff/nholford
Received on Fri Oct 26 2007 - 19:26:48 EDT