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Pharmacoepidemiology Methods

2nd term
3 credits
Academic Year:
2021 - 2022
Instruction Method:
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructors:
Jodi Segal

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses. 340.601 or 340.751 or 340.721


Introduces the key elements of pharmacoepidemiology. Explores the utilization and effects of drugs in large numbers of people. Discusses the application of epidemiological methods to pharmacological issues. Focuses heavily on questions of drug safety and effectiveness, concentrating on clinical patient outcomes and on evaluating the use of therapies. Applies the research methods of clinical epidemiology (e.g., randomized trials, cohort studies, case-control studies, use of secondary data, attention to biases and confounding) to the content area of pharmacology (e.g., determinants of beneficial and adverse drug effects, effects of patient heterogeneity on drug effect, effects of non-adherence, active and passive surveillance for adverse events).

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Describe the development of the drug regulation processes in the United States
  2. Recognize the role of industry in drug development
  3. Appraise pharmacovigilance systems
  4. Access different data sources for pharmacoepidemiology studies and their strengths and limitations
  5. Apply epidemiological techniques to questions about drug effectiveness or drug safety
  6. Recognize the role of industry in drug development
  7. Explain the drug approval process in the US
Methods of Assessment:

Class participation/exercises/LiveTalk 30%, performance on a midterm exam (multiple choice and essay) 30%, and final exam (multiple choice and essay) 40%.

Enrollment Restriction:

graduate students only

Instructor Consent:

No consent required