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WIREs Nanomed Nanobiotechnol
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Product quality for nanomaterials: current U.S. experience and perspective

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In recent years, there has been an increased focus on developing novel drug delivery systems and targeted therapies through the use of nanotechnology and nanomaterials. Such focus is translating to an increasing number of investigational new drug (IND) applications, new drug applications (NDAs), and abbreviated new drug applications (ANDAs) for drug products containing nanomaterials to the United States Food and Drug Administration (FDA). Although subject to the same rigorous regulatory standards and regulatory pathways as any drug product, unique properties that arise from the small size, large surface area, and polydispersity of nanomaterials may lead to additional scientific considerations when following current FDA guidelines and practices for drug evaluation. This review article will discuss these scientific considerations based on the experience with FDA‐approved drug products containing nanomaterials. WIREs Nanomed Nanobiotechnol 2015, 7:640–654. doi: 10.1002/wnan.1338 This article is categorized under: Biology-Inspired Nanomaterials > Protein and Virus-Based Structures
Nanomaterials may impact sample preparation, processing, dispensing, and administration. (a) Discreet nanoparticles may pass through filters intended to remove non‐dissolved material. (b) Nanoparticles may interact with filter media, causing clogs or loss of material. (c) 10 nm gold nanoparticles interacting with a syringe filter with an average pore size of 220 nm, resulting in significant loss of nanoparticles in the filtered product. Note that the gold nanoparticle solution is pink prior to filtration, and is clear after filtration (arrow), indicating removal of the nanoparticles. (d) 10 nm gold nanoparticles interacting with storage container as observed by the blue film on the top of the container (arrow). (e) Nanomaterials interacted with the plastic syringe surface, resulting in a lower dose being administered (arrow).
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