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Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation

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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

Who Should Attend 

The target audience for these webinars includes physicians, pharmacists, nurses, and scientists, as well as their regulatory and commercial colleagues, from industry, academia, medical centers, and health authorities, who are involved in all phases of drug development and safety evaluations throughout the product lifecycle.

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss the timing of assessment of QT prolongation in drug development
  • Discuss the recent developments in QT assessment

Special Offers 

Series Discount Available*

Buy 2 archives in this series
and save 10%
Buy 3 or 4 archives in this series
and save 15%
Buy the whole series
and get one archive free

*Order must be placed in one transaction for savings to be applied.

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
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Information about Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199

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Registration Fees 

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Registration Information

Printable Registration Form

Series Discount Available*

Save when you purchase two or more archived webinars in this series.
Buy two archives in this series and save 10%
Buy three or four archves in this series and save 15%
Buy all five archives in the series and receive one part for free.

*Order must be placed in one transaction for savings to be applied.

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.

Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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