Quality by Design: An Overview of the Basic Concepts

Innate immunity and acetaminophen-induced liver injury: Why so many controversies?

“…These initiatives have led to efforts to evaluate every step of the pharmaceutical processing stream to determine what capabilities can be developed and applied to give better quality and control capabilities. Many of these efforts are largely related to the application of PAT tools to unit operations in the processing stream to understand and monitor the physical and chemical changes occurring during processing 2. Some specific examples of technologies that are gaining wide acceptance in the pharmaceutical industry for solids process monitoring are the use of near‐infrared (NIR) instrumentation for monitoring and controlling moisture content during fluid bed applications and content uniformity end‐point detection during blending 3–13.…”

Development of Quality-By-Design Analytical Methods

“…[1][2][3][4] The overarching goal of QbD is to embed quality into pharmaceutical products to ultimately protect patient safety. Many other regulatory agencies around the world have also adopted similar approaches.…”

Implementation of Quality by Design for the Development and Validation of Pioglitazone Hydrochloride by RP-UPLC with Application to Formulated Forms

“…QbD delivers a better understanding of method capabilities and limitations and ensures a superior chance of successful downstream method validation and transfer. It has become an important paradigm in the pharmaceutical industry since its introduction by the US Food and Drug Administration [3][4][5][6][7]. The QbD concept can be extended to analytical methods [8][9][10][11][12][13][14][15].…”