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The following message was posted to: PharmPK
"HUTMACHER, MATTHEW [Non-Pharmacia/1820] (by way of David Bourne)"
>Does anyone have any advice on how to group adverse events (AEs) for a
>that titrates the patient's dose to a specified range of
concentrations? Usually this is done by dose group, but that no longer
makes sense. My first instinct is to just stick to grouping AEs by
>medication since these are the most probable factors that determined
the need to titrate anyway.
If this is a randomized concentration controlled trial (which it sounds
like except you are not clear about the assignment randomization aspect)
then you can use the randomized concentration group in exactly the same
way you would have used the randomized dose group. Concentration in RCCT
is the exact analogue of dose in a RDoseCT but with less variability due
to PK factors.
Conclusions drawn about the relationship between other covariates
("demographics") will be less reliable than those about concentration
because of the lack of explicit randomization of demographics.
Nick Holford, Divn Pharmacology & Clinical Pharmacology University of
Auckland, 85 Park Rd, Private Bag 92019, Auckland, New Zealand
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