Statistical design of experiments (DoE; also termed factorial experimental design or FED) is a powerful tool for developing processes efficiently. DoE has been used in many phases of API development, ranging from initial process optimization to design space studies in validation to assay development. In the time spanning 2003 – 2013 there were over 100 manuscripts in Organic Process Research & Development that described using DoE for various stages of API optimization. The recent review below summarizes selected publications from that group of manuscripts to show how DoE findings have been applied for process scale-up and other aspects of API development.
Weissman, S. A.; Anderson, N. G. “Design of Experiments (DoE) and Process Optimization. A Review of Recent Publications” Org. Process Res. Dev. XXXX, XX, XXXX; DOI: 10.1021/op500169m
