Authors: Dr. Arunachalam Venkatesan
Abstract: In the pharmaceutical industry, ensuring the quality of drug formulations is paramount to their efficacy, safety, and market success. Quality by Design (QbD) principles provide a systematic approach to formulation development that emphasizes understanding the product and process variability and systematically controlling them to achieve desired quality attributes. This paper explores the application of QbD principles in optimizing drug formulations, discussing key elements such as risk assessment, design of experiments (DoE), and the establishment of a design space. Case studies and examples illustrate how QbD facilitates the development of robust drug formulations that meet regulatory requirements and patient needs efficiently.
Keywords: Quality by Design (QbD), drug formulation, design of experiments (DoE), risk assessment, design space, pharmaceutical development.
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