RE: Reporting Modeling Results

Nick, Tacrine, My understanding (correct me if I'm wrong), was that the traditional analysis was unconvincing wrt efficacy and the model you developed ultimately helped justify approval. Presumably, some patients had an improved outcome from the use of the drug. My experience with end of phase IIa meetings is that they are quite helpful in dose selection (often supporting the position that clin pharm took within the company). WRT the lamictal example, while the analysis was not accepted as sufficient support for label change, the dosing algorithm that was developed was used in a trial ! that led to label change. There are lots of example within companies, or analyses that led to rational dose decisions, that didn't end up published. This is what you've been preaching for 20 years or so - are you refusing to acknowledge your success? Mark Mark Sale MD Next Level Solutions, LLC www.NextLevelSolns.com 919-846-9185 > -------- Original Message -------- Subject: Re: [NMusers] Reporting Modeling Results From: Nick Holford <[EMAIL PROTECTED]> Date: Fri, October 26, 2007 7:26 pm To: "'nmusers'" < > > [email protected] > > > 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 @auckland.ac.nz > > tel:+64(9)373-7599x86730 fax:+64(9)373-7090 > > www.health.auckland.ac.nz/pharmacology/staff/nholford