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What basic protocole would you suggest we use to get a first estimation
of a near-optimal dosing regimen in mice for a new anti-infective agent
on which we have little information? We will use the dosing regimen for
evaluation of efficacy in infected mice.
Thank you,
M. Thomas
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The following message was posted to: PharmPK
"Mario Thomas (by way of David_Bourne)" wrote:
>
> PharmPK - Discussions about Pharmacokinetics
> Pharmacodynamics and related topics
>
> What basic protocole would you suggest we use to get a first estimation
> of a near-optimal dosing regimen in mice for a new anti-infective agent
> on which we have little information? We will use the dosing regimen for
> evaluation of efficacy in infected mice.
Use whatever info you have from in vitro studies of the
anti-infective agent to establish a likely in vivo target conc e.g.
at least the MIC. Try to use the unbound in vitro concentration and
this will then predict a reasonable starting place for an unbound
conc in vivo.
Do some pilot PK studies in the mice to discover the doses needed to
achieve/maintain the target conc.
Then do your effectiveness studies with this regimen. Establishing an
optimal regimen will necessarily involve further experimental studies
in vivo using different regimens.
--
Nick Holford, Divn Pharmacology & Clinical Pharmacology
University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New Zealand
email:n.holford.at.auckland.ac.nz tel:+64(9)373-7599x6730 fax:373-7556
http://www.phm.auckland.ac.nz/Staff/NHolford/nholford.htm
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