Abstract

The pharmaceutical industry faces increasing pressure to develop safe, effective, and cost-efficient medications in a timely manner. To meet these demands, researchers and manufacturers rely on robust methodologies such as Design of Experiments (DoE) to optimize formulation, manufacturing processes, and analytical methods. This abstract provides an overview of the role of DoE in pharmaceutical development, highlighting its applications and benefits. By systematically varying multiple factors simultaneously, DoE enables researchers to efficiently explore the design space, identify critical factors, and optimize conditions to achieve desired outcomes. From formulation development to quality by design implementation and analytical method optimization, DoE serves as a cornerstone of pharmaceutical innovation, enhancing product quality, consistency, and regulatory compliance. As the industry continues to evolve, the adoption of DoE principles will be crucial for accelerating drug development timelines, reducing costs, and improving patient outcomes.