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Activity Number: 193
Type: Contributed
Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #317203
Title: Simulation of Complex Dosing Regimens with RxODE
Author(s): David A. James* and Wenping Wang and Karen Melissa Hallow
Companies: Novartis and Novartis and University of Georgia
Keywords: PK/PD ; ordinary differential equation ; modeling and simulation

Compounds with complex pharmacokinetics and pharmacodynamics (PKPD) pose greater challenges to drug development when determining a proper posology that optimally balances the new drug's efficacy and safety. Moreover, regulators routinely challenge sponsors to provide evidence supporting the proposed dose and/or dosing regimen in a submission package. Thus, justifying the selected posology is often a very difficult and important drug-development question and a constant theme in submissions and in advisory committee meetings.

In this poster, we describe and illustrate the use of a dosing regimen simulation tool (RxODE) that allows clinical pharmacologists, pharmacometricians, and statisticians to explore the effect of complex dosing regimens on patients' drug exposure and clinical responses. PKPD models may be expressed through sets of ordinary differential equations (ODE) using a simplified language; this set of ODE expressions get translated into C, compiled, and dynamically linked into a running instance of R (www.r-project.org) for fast execution.

We illustrate the use of RxODE in various ophthalmic and monoclonal antibody projects.

Authors who are presenting talks have a * after their name.

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