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Emerging Standards for Nanotechnology-Enabled Medical Products



Bryant C. Nelson, Caterina Minelli, Shareen H. Doak, Matthias Roesslein


The development and application of nanotechnology-enabled medicinal products, including drugs, devices and in vitro diagnostics, is rapidly expanding in the global market place. In this review, the focus is on providing the reader an introduction to the landscape of commercially available nanotechnology-enabled medicinal 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 medicinal products. The scientific and measurement challenges involved in the development and application of innovative nano-enabled medicinal products motivates the discussion throughout the review.
Annual Review of Analytical Chemistry


Documentary Standards, Drug Products, In Vitro Diagnostics, Measurement Assurance, Medical Devices, Nano-Enabled Medical Products, Nanomedicine


Nelson, B. , Minelli, C. , Doak, S. and Roesslein, M. (2020), Emerging Standards for Nanotechnology-Enabled Medical Products, Annual Review of Analytical Chemistry, [online], (Accessed May 25, 2024)


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Created February 20, 2020, Updated November 6, 2020