Objectives:
This certificate program offers a practical and comprehensive introduction to bioequivalence (BE) analysis in drug development. Designed for professionals and students in pharmaceutical sciences, clinical research, and biostatistics, the course provides hands-on experience with real-world tools and methods essential for modern bioequivalence studies.
Participants will learn to:
- Design, analyze, and interpret bioequivalence studies using statistical methods
- Select appropriate study designs tailored to both regulatory and developmental scenarios
- Make informed decisions based on accurate interpretation of BE data
- Reason about the suitability and assumptions of statistical approaches to bioequivalence.
- Use state of the art software tools including Pumas and PumasCP, in view of classical SAS procedures that are sometimes specified in guidelines.