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The following message was posted to: PharmPK
Dear all,
I'm planning to analyze the steady state at multiple-dosing study.
What technique is general to analyze the attainment of steady state
statistically? Is it a general technique though the analysis method
by the ANOVA using Helmert contrasts was found in some documents? It
would be greatly appreciated if some advice could be gotten moreover.
Best regards,
Kazuoki
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The following message was posted to: PharmPK
There are no firm guidelines here. Some people simply do graphical
examination of trough concentrations. A more rigorous method is the
ANOVA with Helmert contrasts methods. I have also seen some people fit
a model Ctrough = Ctrough,ss*(1 - exp(-k*time)) where k is the rate
constant for approach to steady-state; this can be done using nonlinear
mixed effects models.
I tend to think that rigorous statistical analysis is often overkill.
You can pretty much tell when steady-state or at least approximate
steady-state is reached just by looking at the mean data graphically.
Does it really matter if you say that steady-state is reached by 4 days
or 5 days?
Good luck,
Peter L. Bonate, PhD
Genzyme Corporation
Senior Director, Pharmacokinetics
4545 Horizon Hill Blvd
San Antonio, TX 78229 USA
peter.bonate.-a-.genzyme.com
phone: 210-949-8662
fax: 210-949-8219
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