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The current process analytical technology (PAT) initiative underway within FDA exemplifies the latest consortium between FDA and the pharmaceutical industry that aims to encourage the concepts of quality by design, use of computerized data gathering and evaluation techniques, and process- and product-monitoring methods through advanced instrumentation and data evaluation. This article discusses the concepts that embody PAT. Emphasis is placed on chemometrics, which is the use of mathematical and statistical models to extract and interpret chemical data. PAT can be defined as the optimal application of process analytical chemistry (PAC) tools, feedback process-control strategies, information management tools, and/or product-process optimization strategies to the manufacture of pharmaceuticals. PAT focuses on the principles of building quality into the product and process as well as continuous process improvement. FDA's PAT initiative is being spearheaded by the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science.