“FUTURE CONSIDERATIONS FOR PK/PD RESEARCH”

7/31/00

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Table of Contents

“FUTURE CONSIDERATIONS FOR PK/PD RESEARCH”

Issue for discussion:

“PK/PD Modeling”

Pharmacokinetics (PK) describes the time course of drug concentrations in plasma (and sometimes in other fluids and tissues) resulting from a particular dosing regimen

This simple model links adherence, pharmacokinetics, and viral pharmacodynamics to treatment outcome in a patient population.

Pharmacokinetic Modeling: The PK model accounts for dose-dependent bioavailability, competitive inhibition, and exposure-dependent enzyme induction.

Pharmacodynamic ModelingThe model was previously published.# This simple PD model includes two viral strains (wild type and a pre-existing mutant), long-lived infected and actively infected cells, and different sites of action by PIs and NRTIs.

Abbott used this approach to compare various combinations PI dosing regimens which included low and moderate dose ritonavir and were able to predict:

Building and Evaluating PK/PD Models

This simple model links adherence, pharmacokinetics, and viral pharmacodynamics to treatment outcome in a patient population.

Building and Evaluating PK/PD Models

This simple model links adherence, pharmacokinetics, and viral pharmacodynamics to treatment outcome in a patient population.

Building and Evaluating PK/PD Models

This simple model links adherence, pharmacokinetics, and viral pharmacodynamics to treatment outcome in a patient population.

A simple PK/PD relationship to help understand the potential consequences of changes in dose regimens or formulations

PK/PD modeling for AIDS: Where do we stand today?

General PK/PD modeling: Where do we stand today?

PK/PD modeling: Where do we go from here?

PK/PD modeling: Where do we go from here?

PK/PD modeling: Where do we go from here?

Author: Blaschke