Princípios do planejamento de experimentos (doe) no contexto de analytical quality by design

Abstract

The pharmaceutical industry has increasingly prioritized quality in product development, not only at the time of launch but throughout the entire drug lifecycle, with a greater focus on treatment efficacy and patient safety. To meet the growing and urgent demands of society, it is necessary to implement a system that enables agile improvements with minimal obstacles. Quality by Design (QbD), addressed in this work, is a tool that allows the pharmaceutical industry to respond effectively to evolving healthcare needs. With the emergence and the reformulation of products, an effective model for both manufacturing and analytical development is essential to ensure greater reliability during regulatory approval. Design of Experiments (DoE) has shown high viability as a statistical tool to optimize processes and enable robust and efficient industrial production. Given the wide range of QbD applications, specific subcategories have emerged, with AQbD (Analytical Quality by Design) being the approach focused on applying this framework to analytical development. This work aims to present the application of DoE within the QbD framework, highlighting its applications and approaches in drug development in order to maintain high quality standards, while increasing efficiency and reducing resource consumption.