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The following message was posted to: PharmPK
As you may know, there seems to be a history of some sort of competition on
which scientific fields should necessarily be involved in pharmacometric
modeling, e.g., in
PK/PD (including scaling issues, inter-species etc.)
Clinical Trial Simulation (ususally with PK/PD in ClinPharm as a
One reason for that was (is) that those disciplines having a very interest in
the results (e.g., ClinPharm) took over a driving role, sometimes supported by
Biostatistics, but sometimes for that reason or another, only very hesitantly.
Although, one should also not forget about the fact, that the foundations in
terms of modeling methodology even for population PK were layed out also by
statisticicans. It seems that some companies taking into account the rather
complex algorithms, new statistical methods and interpretation issues (see for
example the "significance" of covariates in PK/PD, the model selection process
etc.) have now established global modeling groups (Novartis, Glaxo) that may be
in charge of modeling and data mining. Accordingly, it would be great to have
some exchange on how these activities are organised in the various companies.
Which companies have established or are about to establish modeling groups?
Which disciplines are represented (ClinPharm, Biostatistics, ...)?
Which discipline are the modeling groups reporting in?
Does modeling also involve bioinformatics and data mining or are those
activities allocated to other groups (although the technique (data mining,
search for relationships regardless if they might be considered to be
qualitative or quantitative) is quite similiar across the various
Provided that starting from this trial enough information can be collected
(Christmas wish), I would volunteer to compile it and make it accessible to the
Thanks a lot for your cooperation.
Merry Christmas to ALL and a Happy New Year!
Dr. Harry Mager
Head Biometry & Pharmacometry
PH-PD-GCP Biometry & Pharmacometry
D-42096 Wuppertal / Bldg. 470
Telefon: +49 (0) 202-36-8891
Telefax: +49 (0) 202-36-4788
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