Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through November 5, 2015.
Broadcast time: 1 hour 5 minutes

Series Overview

These core lectures will focus on the essentials of clinical pharmacology in drug development. They will outline basic pharmacological and therapeutic principles that show how drugs get into the body, how they produce their effects, what happens to them in the body, and how evidence of their therapeutic effect as well as unwanted effects are assessed. The information is vital to an understanding of how drugs are to be used safely and effectively. The principles will be illustrated by practical applications offered by examples from real experience.

Five lectures will cover the following topics:

• Pharmacokinetics
• Pharmacodynamics
• Principles of Modeling and Simulation
• Determining the Safe First Human Dose
• Assessment of QT Prolongation

Part 3: Principles of Modeling and Simulation

Clinical scientists are increasingly relying on modeling and simulation (M&S) approaches as a way to understand the underlying biology and sources of variability driving drug response, to describe the relationship between drug exposure and biomarkers or drug effects, and to predict the outcome of potential trial designs.  M&S facilitates the integration of data, knowledge and assumptions over the lifespan of a drug, and allows pharmaceutical scientists to make rational, quantitatively-based decisions throughout a drug’s development.

This session will focus on the following topics:

• What is modeling? What is simulation?
• How can M&S help quantify and understand disease biology and drug mechanism of action
• How is M&S used to understand the sources of between-subject variability in disease, exposure, andclinical response?
• How can M&S be used to design a more efficient and effective, and less costly, clinical trial?