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Why It Matters
Pharmaceutical process characterization is central to Quality by Design because it defines how variations in process parameters affect the ability to meet product quality specifications, thereby supporting proven acceptable ranges and robust manufacturing.
Provenance
Discovered via ArXiv and published by ArXiv.
Key Claims
Original description
Pharmaceutical process characterization is central to Quality by Design because it defines how variations in process parameters affect the ability to meet product quality specifications, thereby supporting proven acceptable ranges and robust manufacturing. In practice, however, characterization still relies largely on factorial design of experiments (DOE) approaches, which are inefficient for resolving multivariate pass/fail boundaries in higher-dimensional spaces. While Bayesian optimization has transformed process optimization, adaptive methods for multi-objective process characterization re...
Discovered via ArXiv
Research papers and preprints from arXiv.
Publisher: arxiv.org
ID: http://arxiv.org/abs/2609.24954v1 · Indexed about 1 hour ago