Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 4: Determining the Safe First Human Dose
Continuing Education Credits are not available for the archived offering.
This archive may be purchased through November 5, 2015.
Archive duration: 1 hour 28 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 4: Determining the Safe First Human Dose
Dosing a compound for the first time to humans is a significant step in the R&D process.
This session will focus on the following topics:
- How to use non-clinical data in determining a safe starting dose (including determining the minimum anticipated biological effect level [MABEL])
- Risk assessment and risk mitigation (including consideration of healthy vs patient volunteers)
- Defining an appropriate dose range that maximizes understanding of pharmacokinetics, pharmacodynamics, and safety/tolerability at reasonable levels of risk
- Dose escalation decisions (including consideration of an exposure cap)
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 risk assessment and risk mitigation
- Explain dose escalation decisions
Ways to register
Series Discount Available*
Buy 2 webinars in this series and save 10%
Buy 3 or 4 webinars in this series and save 15%
Buy the whole series and get one webinar free
*Order must be placed in one transaction for savings to be applied.
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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.