Menu Back toFive-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 4: Determining the Safe First Human Dose

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

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 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.

Learning objectives

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

  • Discuss risk assessment and risk mitigation
  • Explain dose escalation decisions

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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.

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