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Module 3 - First in Human and Early Clinical Trials

Module Objectives

This module will provide information on the following topics:
  • The challenges faced when taking a new chemical entity into humans for the first time and how translational sciences can be used to better design and analyze first in human trials.
  • The essential domains and considerations in developing and qualifying biomarkers, along with strategies for their effective implementation in drug discovery and development.
  • Case studies of specific translational platforms for predicting and understanding QTc prolongation and cardiovascular toxicity, nephro- and hepatotoxicity, and harmful drug-drug interactions.
  • A range of techniques that are improving the ability to predict human exposure response relationships from in vitro and preclinical data, including: microdialysis, inter-species scaling, and inter-species PBPK/PD modeling.
Upon completion of this third module, the learner should be able to:
  1. Describe basic pharmacokinetic scaling methods used to translate exposure-response to dose-response;
  2. List considerations associated with dose selection;
  3. Discuss the value of integrating translational PKPD in early development; and
  4. Describe a Clinical Trial Simulation (CTS), its benefits/risks, assumptions, best practices, and process.

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