Quality by Design Integration of Design of Experiments for Tablet Formulation Optimization and Process Validation
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J Suksaeree, C Monton, P Maneewattanapinyo
AAPS PharmSciTech, 2026
Springer
Quality by design (QbD) and design of experiments (DoE) have become central to modern pharmaceutical development, yet most guidance and reviews treat formulation development, process optimization, and process validation as largely separate activities. This narrative review focuses specifically on oral tablet products and traces how formulation-level DoE can be used to systematically define, refine, and confirm design space across the full lifecycle of tablet development. Published case studies are organized along a formulation-to-validation …
