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Module 2 - Drug Discovery and Early Development

Module Objectives

In recognition that disease and drugs alter natural biochemical and physiological networks, systems pharmacology and bioinformatics are computational platforms that are increasingly network based. This module will provide information on the following topics:
  • Computational tools that are being used to identify new drug targets and biomarkers, as well as for re-purposing older approved drugs.
  • The major sources of attrition in drug development continue to be lack of efficacy and unacceptable adverse drug effects. New cell-based methodologies could provide early reliable indicators of these critical drug properties
  • New cell-based bioassays hold the potential for providing insights into drug properties without the need for animal testing. This lecture will introduce cell and tissue culture systems, as well as the latest advancements in assessing drug properties.
  • Although the theory for physiologically-based modeling of drug disposition (PBPK) is well established, contemporary hardware, software, and bioanalytical tools have brought PBPK to the forefront for streamlining drug development. This systems-based modeling approach represents the best available platform for integrating molecular, cellular, pharmacological, and patho-physiological controls to understand determinants of drug exposure and sources of inter-subject and inter-species variability.
  • Analogous to PBPK modeling, physiological pharmacodynamic modeling seeks to integrate molecular, cellular, and patho-physiological factors that regulate the time-course of pharmacological effects.
Upon completion of this second module, the learner should be able to:
  1. Discuss how predictive network models provide a path for prioritizing targets, stratifying patient populations, and matching patient-specific subtypes to most appropriate therapeutic;
  2. Explain how the potential of stem cell derived tissues will influence basic research;
  3. Predict the systemic and total clearance using a variety of in vitro metabolism systems;
  4. Discuss pharmacokinetics from a physiological perspective
  5. Describe the basic of pharmacodynamic modeling.


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