This page contains links to the presentation slides of the Applied Biostatistics in the Pharmaceutical Industry course I gave at Tel Aviv University in 2011. All the slides are in English.
The presentations are available for personal use and learning. In case you want to share the presentations, please share the link to this page.
- Review of new drug development process
- The regulatory environment and the role of the statistician
- Statistical analysis of biological assays
- Qualification and validation of analytical and bioanalytical methods
- Stability and shelf life estimation
- Quality by Design
- Design of Experiments. The data for cell assay example are available (CSV file)
- Pharmacokinetics and Pharmacodynamics
- Topics in Clinical Trials