Description
This work describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process, including preformulation, formulation, process study and optimization, scale-up, robust processes and formulation development. The authors show how to overcome pharmaceutical, technological and economic constraints on experiment design.Table of Contents: 1. Overview 2. Screening 3. Factor Influence Studies 4. Statistical and Mathematical Tools 5. Response Surface Methodology 6. Optimization 7. Variability and Quality 8. Exchange Algorithms 9. Mixtures 10. Mixtures in a Constrained Region of Interest
