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
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:
- 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.
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
Ways to register
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.
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- 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.