Re: [NMusers] Reporting Modeling Results

Mark,

Your examples illustrate PKPD to aid drug development and the rational use of medicines. I don't disagree with this.

But you keep missing my point that the actions of regulators and drug marketers do not discover how to use medicines. Many groups in industry, academia and clinical medicine contribute to this knowledge by designing, performing, analysing and reporting clinical trials -- it is not the role of regulators and marketers to do these things. This is why I said "Regulatory and marketing are minor shadows in the big picture of using medicines to improve health."

Nick


> 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

--
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 Sat Oct 27 2007 - 14:49:39 EDT