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Adv Drug Deliv Rev. 2019 Jun 19. pii: S0169-409X(19)30066-3. doi: 10.1016/j.addr.2019.06.003. [Epub ahead of print]

Nanomedicines - Tiny particles and big challenges.

Author information

United States Pharmacopeia, Rockville, USA.
Health Sciences Authority (HSA), Health Products Regulation Group, Singapore.
Fraunhofer-Institute for Molecular Biology and Applied Ecology, Frankfurt, Germany.
Agência Nacional de Vigilância Sanitária (ANVISA), Coordination of Therapeutic Equivalence, Brasília, Brazil.
Joint Research Centre, European Commission, Ispra, Italy.
National University of Singapore, Faculty of Science, Department of Pharmacy, Singapore. Electronic address:


After decades of research, nanotechnology has been used in a broad array of biomedical products including medical devices, drug products, drug substances, and pharmaceutical-grade excipients. But like many great achievements in science, there is a fine balance between the risks and opportunities of this new technology. Some materials and surface structures in the nanosize range can exert unexpected toxicities and merit a more detailed safety assessment. Regulatory agencies such as the United States Food and Drug Administration or the European Medicines Agency have started dealing with the potential risks posed by nanomaterials. Considering that a thorough characterization is one of the key aspects of controlling such risks this review presents the regulatory background of nanosafety assessment and provides some practical advice on how to characterize nanomaterials and drug formulations. Further, the challenges of how to maintain and monitor pharmaceutical quality through a highly complex production processes will be discussed.


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