This course introduces regulatory, clinical, statistical and logistical considerations in assessing the relative bioavailabilities of formulations. A heavy emphasis is placed on clinical trial design, and biostatistics involved in second entry drug applications to regulatory bodies. Students will learn about the methods, regulations, techniques, pharmacokinetics, and biostatistics involved in creating bioequivalence studies, at an introductory level. The course has a heavy mathematical bias with a component dedicated to mathematical modeling and basic programming in R-project, an open source statistical package. After taking this course, students will understand the steps required to set up single-dose or steady-state pilot and pivotal bioequivalence trials using parallel, crossover and replicate designs. Students will be able to take a data set of plasma concentrations and be able to process and interpret the results of the trial. Students will gain a deeper understanding and context of the regulatory differences involved in generic drug testing between Canada, the United States and Europe.