Abstract
The Food and Drug Administration (FDA) and pharmaceutical industry have used standards to assess material biocompatibility, immunotoxicity, purity, and sterility (as well as many other properties) for several decades. Nanoparticle developers and manufacturers leverage well-established methods as much as possible. However, the unique properties of nanomaterials often interfere with standardized protocols, giving false-positive or false-negative results. This chapter provides details of some of the problems which can arise during the characterization of nanoparticle samples. Additionally, we discuss ways to identify, avoid, and resolve such interference, with emphasis on the use of inhibition and enhancement controls.
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References
For the remainder of the chapter we confine the discussion to the IND process for drugs regulated through the FDA’s Center for Drug Evaluation and Research (CDER). A similar process is required in the Investigational Device Exemption (IDE) filing for a device regulated through the FDA’s Center for Devices and Radiological Health (CDRH).
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Acknowledgments
This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under contract N01-CO-12400. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
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McNeil, S.E. (2011). Challenges for Nanoparticle Characterization. In: McNeil, S. (eds) Characterization of Nanoparticles Intended for Drug Delivery. Methods in Molecular Biology, vol 697. Humana Press. https://doi.org/10.1007/978-1-60327-198-1_2
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DOI: https://doi.org/10.1007/978-1-60327-198-1_2
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Publisher Name: Humana Press
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