Introduction
The cost of research and development in the pharmaceutical industry has risen sharply in recent decades, partly due to high statutory safety and quality requirements. Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes product and process understanding and process control, based on sound science and quality risk management. The QbD approach should enhance product manufacturability. Identifying potential critical quality attributes (CQAs) of the drug product, so that those product characteristics having an impact on product quality can be studied and controlled. It is also important to recognize that quality cannot be tested into products; it should be built in by design.
Intelligent automation offers the opportunity to improve both aspects of the drug development process. The goal of this work is to demonstrate the potential of a completely automated pharmaceutical development of a dosage form from powder to granules to finished tablet.
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Intelligent automation offers the opportunity to improve both aspects of the drug development process. The goal of this work is to demonstrate the potential of a completely automated pharmaceutical development of a dosage form from powder to granules to finished tablet.
Download full article