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Preclinical immunological testing of engineered nanoparticles: regulatory and methodological challenges

  • Marina A. Dobrovolskaia (a1) and Scott E. McNeil (a1)



This is a copy of the slides presented at the meeting but not formally written up for the volume.


The potential applications of nanomaterials in medicine are numerous and very promising. Translation of potential to practical value, however, requires demonstration not only of efficacy but also of safety. Assessing nanoparticles? potential toxicity to the immune system is an important step in building nanopartricles? safety profile. Unfortunately, immunotoxicological analysis of new molecular entities is not a straightforward process. There is no universal guide for immunotoxicity in general, as there is no formal guide specific for nanomaterials?. Our presentation will address key points for consideration during early preclinical studies on nanoparticles? effects to the immune system. We will also review methodological challenges in in vitro preclinical immunological testing of nanomaterials developed for biological applications. Funded by NCI Contract N01-CO-12400.




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