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This review aims to trace the evolution of design of experiments in pharmaceutical processes and its incorporation into quality by design frameworks.

August 1, 2026Open Access

ADVANCEMENTS AND APPLICATIONS OF DESIGN OF EXPERIMENTS (DOE) IN PHARMACEUTICAL PROCESS OPTIMIZATION: A QUALITY BY DESIGN (QbD) PARADIGM

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Review outlines advancements in design of experiments for optimizing pharmaceutical processes, highlighting implications for quality by design.

This review aims to trace the evolution of design of experiments in pharmaceutical processes and its incorporation into quality by design frameworks.
Reviewed historical transitions from one-factor-at-a-time to DoE methodologies.
Explored integration of DoE with ICH guidelines and its application in various unit operations.
Analyzed modern technological integrations such as AI and machine learning in DoE frameworks.
Outlined the shift to proactive, structured methodologies improving pharmaceutical manufacturing.
Identified key applications of DoE in formulation, chromatography, and advanced bioprocessing.
Demonstrated the enhanced robustness and yield of processes through real-time monitoring and AI integration.

Amarnath et al. (2026) studied this question.

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Review outlines advancements in design of experiments for optimizing pharmaceutical processes, highlighting implications for quality by design.