Environmental Engineering Reference
In-Depth Information
2020
2010
2000
1990
1980
1970
Fig. 6.5 FDA-approved nanotechnology-based products in pharma and their launch year (The
Name can be read as: brand name and type of drug delivery system)
effects these small particles can exert are these effects are transient or permanent, to
what extent and what type of cell might be a target for these small particles are the
main safety concern for industry and for FDA.
These effects are route-specific, e.g. for oral increased bioavailability,
subcutaneous-sensitization, dermal penetration/phototoxicity, occcular-intravetreal
retention, inhalation-systemic bioavailability, intravenous-sterility; this informa-
tion can give alter on safety. Currently, CDER/FDA
s guidelines on safety require-
ments are rigorous. However, if required the demands from research in academia
and industry might result in additional regulation on toxicological testing. It is
equally important to educate public on use of nanoparticle specification at which
concentration or at which particle size they might cause adverse effects.
'
Conclusion and Perspective
Nanotechnology in health care system is growing rapidly and needs attention
from scientists in finding suitable toxicological assays and analysis methods.
To date, used techniques and assays are well established, however sophisti-
cated assays combined with new techniques might provide more advance data
and understanding of toxicity behavior. Toxicogenomics endeavors to under-
stand the biological effects of cellular products controlled by the genomes
such as RNA, proteins, and metabolites. Compared with a conventional assay,
new combinations such as assay-electrochemical analysis, assay-cell ROS
generation, assay-visualization techniques might be useful to get more insight
in toxicology. Altogether, nanotoxicity research needs multidisciplinary col-
laboration and debate on needs. The role of regulatory bodies is very crucial
in getting inputs for new assays.
