Journal article
Emerging Standards and Analytical Science for Nanoenabled Medical Products.
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Nelson BC
National Institute of Standards and Technology (NIST), Biosystems and Biomaterials Division, Gaithersburg, Maryland 20899, USA; email: bryant.nelson@nist.gov.
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Minelli C
National Physical Laboratory, Chemical and Biological Science Department, Teddington TW11 0LW, United Kingdom.
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Doak SH
Swansea University Medical School, Institute of Life Sciences, Swansea SA2 8PP, Wales, United Kingdom.
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Roesslein M
Swiss Federal Laboratories for Materials Science and Technology (EMPA), Materials Meet Life Department, CH-9014 St. Gallen, Switzerland.
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Published in:
- Annual review of analytical chemistry (Palo Alto, Calif.). - 2020
English
Development and application of nanotechnology-enabled medical products, including drugs, devices, and in vitro diagnostics, are rapidly expanding in the global marketplace. In this review, the focus is on providing the reader with an introduction to the landscape of commercially available nanotechnology-enabled medical products as well as an overview of the international documentary standards and reference materials that support and facilitate efficient regulatory evaluation and reliable manufacturing of this diverse group of medical products. We describe the materials, test methods, and standards development needs for emerging medical products. Scientific and measurement challenges involved in the development and application of innovative nanoenabled medical products motivate discussion throughout this review.
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Language
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Open access status
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closed
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Identifiers
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Persistent URL
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https://sonar.ch/global/documents/41023
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