NONMEM Users Network Archive

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Covariate hierarchy

From: Joachim.Grevel
Date: Tue, 15 Jul 2008 08:51:36 +0200

Dear Stephen and all other NMusers,

Stephen Duffull wrote yesterday:
Perhaps a slightly more generic framework is to consider that covariates
naturally align to a
hierarchical framework,...

Now, when we consider size (e.g. lean body mass) a universal covariate for
pharmacokinetics, shouldn't we write Phase I (dose escalation) protocols
for just about all new drugs (not only anticancer drugs) with doses based
on the size of the volunteers (patients)? What do my colleagues from
industry and the regulatory agencies think?


Joachim GREVEL, Ph.D.
MERCK SERONO International S.A.
Exploratory Medicine
1202 Geneva
Tel: +41.22.414.4751
Fax: +41.22.414.3059
Email: joachim.grevel

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Received on Tue Jul 15 2008 - 02:51:36 EDT

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