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 5: Assessment of QT Prolongation

Assessment of arrhythmogenic potential of a new drug entity via assessment of the impact on the QT interval of the ECG has become a standard feature of drug development since ICH E14 guidance was issued in 2005.

This session will focus on the following topics:

• Brief overview of the ICH E14 and the Thorough QT Study (TQTS);
• A discussion on the timing of TQTS in drug development and impact of TQTS in subsequent drug development
• What type of QT assessment and analysis is recommended in Phase 1 and Phase 2 (early drug development)
• A discussion on recent developments in QT assessment whereby a combination of non-clinical and early clinical QT assessment with concentration response modeling could potentially obviate the need for TQTS