This course will provide an introduction to pharmaceutical analysis and discuss the importance of assuring the pharmaceutical quality of medicinal products with an emphasis on establishment of quality control assays and specifications, bioequivalence testing of generic drugs, special considerations for biopharmaceutical products, and the regulatory process in Canada. In addition, the course will discuss the application of analytic techniques in clinical laboratory medicine with a focus on commonly used tests to monitor patient health and the therapeutic use of drugs, including tests for personalized drug therapy. The course includes a laboratory component which will present drug formulation and related quality control issues.