PHAR-840 Systems Concepts and Drug Safety
Spring for 2017-2018
The course introduces students to the broad concepts of quantitative systems biology and the application of these principles to the specific issues of particular interest to the Food and Drug Administration and related national and international regulatory bodies. General topics include:

• Introduction to current problems in drug and biologicals safety including first-in-human serious adverse events (SAEs); clinical trial SAEs; post-marketing surveillance SAEs
• Quantitative foundations of drug safety and the concept of systems pharmacology; chaos theory, network analysis and epidemiological studies in assessing safety of drugs and biologicals
• Case studies of SAEs and systematic approaches to case evaluation and causal inference

Students can be assisted on a limited case-by-case basis for placement at FDA for a post-course summer internship.
Credits: 2
Prerequisites: None
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