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Modeling and Simulation in Drug

Development with SimBiology®

Shayoni Dutta and Fulden Buyukozturk

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Modeling Approaches in Drug Development

Discovery Preclinical studies Clinical studies

▪ Assess safety and efficacy

▪ Define target population (popPK/vPop)

▪ Identify drug target ▪ Does the drug reach the target?

▪ Find safe and efficient dose for

first in-human study

Systems Biology (PB)PK / PD

Quantitative Systems Pharmacology (QSP)

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What is SimBiology?

Build a model

by drawing itSimulate a model Estimate parameters Analyze a model

SimBiology® provides Apps and programmatic tools to:

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SimBiology and the MATLAB ecosystem

SimBiology

SimBiology

project

• Programming language

• Rigorously tested, maintained and updated

• App-based and programmatic workflows

• Comprehensive set of built-in analysis tools

• Accelerate simulations by compiling to C-code

• Projects promote continuity and reproducibility of results

• Graphical model representation

MATLAB

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Examples of published user projects

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Generate a deployable App for simulation

modeling group

Model users

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Share your simulation App via an URL in your intranet

Use App Designer to

create MATLAB apps

Use App Designer to

create MATLAB Apps

Author

Use MATLAB Compiler

to package

Package

Domain Expert

Host

Use MATLAB Web App

Server to deploy and

share

IT System Administrator

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Share your simulation App via an URL in your intranet

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SimBiology Community: an online community for users

An online gathering place

▪ for scientists in QSP, PBPK,

PK/PD modeling

▪ to discuss, share code and

models, projects and more

▪ to facilitate growth of modeling

and SimBiology communities

Leading SimBiology users are part of

this community

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Learn More

SimBiology Tutorials for QSP, PBPK, and PK/PD Modeling and Analysis : Video Series

▪ Physiologically-based Modeling of Oral Drug Absorption with SimBiology

▪ Integrating PK/PD and Mechanistic Modeling with SimBiology and MATLAB

▪ Compliance with FDA/CE Regulations and Standards

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for a list of additional trademarks. Other product or brand names may be trademarks or registered trademarks of their respective holders.

Thank you