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The following message was posted to: PharmPK
I would appreciate thoughts on the following drug interaction study
For US (FDA) and EU submissions, is it acceptable to do a single dose
drug interaction study or should we dose to steady-state? My
understanding of the US guidance is that drug interaction studies are
to be done at clinically relevant concentrations. Is a large single
dose that gets into the therapeutic concentration range adequate, or do
we need to use the anticipated clinical dose and get to clinical
relevant concentrations via multiple dosing and accumulation?
Characteristics of the drug are:
1) 3 day half-life.
2) metabolites with some, but minimal, activity on the desired target
3) metabolites are not fully characterized structurally
4) assay for metabolites is not yet available, but single dose vs
steady-state part of the interaction study design needs to be defined
5) a metabolically based (CYP)inhibition of elimination of the
development drug is expected
Thank you for your time in responding.
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