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Issue 10, 2010
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Trends in process analytical technology

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Since the promotion of Process Analytical Technology (PAT) by the U.S. Food and Drug Administration (FDA), there has been a flurry of activities happening across related fields. This excitement permeates regulatory agencies, professional societies, academia and industry worldwide. This review surveys the PAT related developments that have taken place in the period 2004–2009. It serves as an introduction to PAT, with highlights on the parallel advances and convergence points across various fields and applications. From this review, five common threads are identified from the underlying trends of the recent global PAT endeavor, namely, organisational objectives, enabling sciences, economic outlook, collaborative efforts and emerging trends. There are also six potential gaps that require further efforts to bridge. The overall PAT venture is promising for delivering an integrated systems approach for quality design, process analyses, understanding and control, continuous improvement, knowledge and risk-based management within the FDA 21st century pharmaceuticalcGMP initiative.

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The article was received on 20 Apr 2010, accepted on 12 Jul 2010 and first published on 16 Sep 2010

Article type: Critical Review
DOI: 10.1039/C0AY00257G
Anal. Methods, 2010,2, 1412-1438

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    Trends in process analytical technology

    W. Chew and P. Sharratt, Anal. Methods, 2010, 2, 1412
    DOI: 10.1039/C0AY00257G

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