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[資源]
Pharmaceutical and Medical Applicationsof Near-Infrared Spectroscopy
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近紅外在制藥學和中藥學中的應(yīng)用第二版，希望大家喜歡 Preface to the Second Edition Since the completion of the first edition of this book, some major developments have shaped the field of near-infrared spectroscopy in the pharmaceutical industry. In 2002, the U.S. Food and Drug Administration (FDA) announced a new initiative to modernize its regulations of pharmaceutical manufacturing and drug quality [1]. The goals of the initiative were to incorporate risk management and quality systems concepts, and ensure that the latest scientific advances in pharmaceutical manufacturing and technology were adopted. Released in 2004, the FDA’s guidance for industry titled PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance was intended to describe a regulatory framework that encourages the implementation and application of innovative techniques to pharmaceutical development and manufacturing [2]. Goals of process analytical technology (PAT) include enhanced understanding of the products and enhanced control of the manufacturing process. In parallel, the European Medicines Agency released notes and guidelines in 2003, 2008, 2012, and 2014 for the use of near-infrared spectroscopy for new submissions and variations [3–6]. These regulatory documents, along with the International Conference on Harmonization documents ICH Q8(R2), Pharmaceutical Development, ICH Q9, Quality Risk Management, and ICH Q10, Pharmaceutical Quality System, helped position near-infrared spectroscopy as a highly relevant tool for achieving control when built-in quality is preferred over quality by testing [7–9]. Consequently, a lot more interest has been given to near-infrared spectroscopy, which has been translated into myriad novel applications for the development, monitoring, and control of pharmaceutical processes. This edition takes full advantage of these developments and brings to readers an up-to-date summary of how the analytical tool, discovered by Sir William F. Herschel in 1800 and developed by Karl Norris in the 1950s and 1960s, is being applied to pharmaceutical manufacturing. In addition, advancements in the field of functional near-infrared spectroscopy (or near-infrared spectroscopy for medicinal applications)have been summarized. Since 2001, a significant amount of work has been done in the medical field, where it is used for what it is best: noninvasive, nondestructive measurements. 1.png 2.png 3.png 4.png 5.png 6.png 7.png 8.png |
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