Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Nanotechnology Programs at FDA

Nanotechnology Programs at FDA

                        Nanotechnology Guidance Documents
          Nanotechnology Task Force Home
          Science & Research
          Science and Research Special Topics
          Nanotechnology Programs at FDA
          Selected FDA Publications Related to the Application, Characterization, Effects, and Evaluation of NanotechnologyNanotechnology Programs at FDA Selected FDA Publications Related to the Application, Characterization, Effects, and Evaluation of Nanotechnology
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe FDA regulatory science program is completing work to foster the responsible development of FDA-regulated products that may contain nanomaterials or otherwise involve the application of nanotechnology. The program establishes the tools, methods, and data to assist in regulatory decision-making, while also providing in-house scientific expertise and capacity that is responsive to nanotechnology-related FDA-regulated products. The publications listed here reflect the scope of work being conducted in FDA laboratories and in collaboration with United States Government Agencies and academia.

Expand All
Application
Agrawal, A.; Pfefer, T. J.; Gilani, N.; Drezek, R. Three-dimensional characterization of optical coherence tomography point spread functions with a nanoparticle-embedded phantom. *Opt. Lett* **2010,** *35* (13), 2269-2271.
Biris, A. R.; Mahmood, M.; Lazar, M. D.; Dervishi, E.; Watanabe, F.; Mustafa, T.; Baciut, G.; Baciut, M.; Bran, S.; Ali, S.; Biris, A. S. Novel Multicomponent and Biocompatible Nanocomposite Materials Based on Few-Layer Graphenes Synthesized on a Gold/Hydroxyapatite Catalytic System with Applications in Bone Regeneration. *J. Phys. Chem. C* **2011,** *115* (39), 18967-18976.
Dong, J. L.; Song, L. N.; Yin, J. J.; He, W. W.; Wu, Y. H.; Gu, N.; Zhang, Y. Co3O4 Nanoparticles with Multi-Enzyme Activities and Their Application in Immunohistochemical Assay. *Acs Applied Materials & Interfaces* **2014,** *6* (3), 1959-1970.
Duncan, T. V. Applications of nanotechnology in food packaging and food safety: barrier materials, antimicrobials and sensors. *J Colloid. Interface. Sci* **2011,** *363* (1), 1-24.
Fan, J.; Yin, J. J.; Ning, B.; Wu, X.; Hu, Y.; Ferrari, M.; Anderson, G. J.; Wei, J.; Zhao, Y.; Nie, G. Direct evidence for catalase and peroxidase activities of ferritin-platinum nanoparticles. *Biomaterials.* **2011,** *32* (6), 1611-1618.
Fan, Z.; Fu, P. P.; Yu, H.; Ray, P. C. Theranostic nanomedicine for cancer detection and treatment. *Journal of Food and Drug Analysis* **2014,** *22* (1), 3-17.
Fu, P. P. Introduction to the Special Issue: Nanomaterials Toxicology and medical applications. *Journal of Food and Drug Analysis* **2014,** *22* (1), 1-2.
He, W. W.; Liu, Y.; Yuan, J. S.; Yin, J. J.; Wu, X. C.; Hu, X. N.; Zhang, K.; Liu, J. B.; Chen, C. Y.; Ji, Y. L.; Guo, Y. T. Au@Pt nanostructures as oxidase and peroxidase mimetics for use in immunoassays. *Biomaterials* **2011,** *32* (4), 1139-1147.
He, W.; Kim, H. K.; Wamer, W. G.; Melka, D.; Callahan, J. H.; Yin, J. J. Photogenerated Charge Carriers and Reactive Oxygen Species in ZnO/Au Hybrid Nanostructures with Enhanced Photocatalytic and Antibacterial Activity. *J. Am. Chem. Soc.* **2013,** *136* (2), 750-757.
Hong, J. S.; Stavis, S. M.; DePaoli Lacerda, S. H.; Locascio, L. E.; Raghavan, S. R.; Gaitan, M. Microfluidic directed self-assembly of liposome-hydrogel hybrid nanoparticles. *Langmuir* **2010,** *26* (13), 11581-11588.
Jennings, T. L.; Becker-Catania, S. G.; Triulzi, R. C.; Tao, G.; Scott, B.; Sapsford, K. E.; Spindel, S.; Oh, E.; Jain, V.; Delehanty, J. B.; Prasuhn, D. E.; Boeneman, K.; Algar, W. R.; Medintz, I. L. Reactive semiconductor nanocrystals for chemoselective biolabeling and multiplexed analysis. *ACS. Nano* **2011,** *5* (7), 5579-5593.
Kamikawa, T. L.; Mikolajczyk, M. G.; Kennedy, M.; Zhang, P.; Wang, W.; Scott, D. E.; Alocilja, E. C. Nanoparticle-based biosensor for the detection of emerging pandemic influenza strains. *Biosens. Bioelectron.* **2010,** *26* (4), 1346-1352.
Kamikawa, T. L.; Mikolajczyk, M. G.; Kennedy, M.; Lilin, Z.; Pei, Z.; Setterington, E. B.; Scott, D. E.; Alocilja, E. C. Pandemic Influenza Detection by Electrically Active Magnetic Nanoparticles and Surface Plasmon Resonance. *Nanotechnology, IEEE Transactions on* **2012,** *11* (1), 88-96.
Karanian, J. W.; Peregoy, J. A.; Chiesa, O. A.; Murray, T. L.; Ahn, C.; Pritchard, W. F. Efficiency of drug delivery to the coronary arteries in swine is dependent on the route of administration: assessment of luminal, intimal, and adventitial coronary artery and venous delivery methods. *J Vasc. Interv. Radiol.* **2010,** *21* (10), 1555-1564.
Karmakar, A.; Iancu, C.; Bartos, D. M.; Mahmood, M. W.; Ghosh, A.; Xu, Y.; Dervishi, E.; Collom, S. L.; Khodakovskaya, M.; Mustafa, T.; Watanabe, F.; Biris, A. R.; Zhang, Y.; Ali, S. F.; Casciano, D.; Hassen, S.; Nima, Z.; Biris, A. S. Raman spectroscopy as a detection and analysis tool for in vitro specific targeting of pancreatic cancer cells by EGF-conjugated, single-walled carbon nanotubes. *J Appl. Toxicol* **2012,** *32* (5), 365-375.
Liang, X. J.; Meng, H.; Wang, Y.; He, H.; Meng, J.; Lu, J.; Wang, P. C.; Zhao, Y.; Gao, X.; Sun, B.; Chen, C.; Xing, G.; Shen, D.; Gottesman, M. M.; Wu, Y.; Yin, J. J.; Jia, L. Metallofullerene nanoparticles circumvent tumor resistance to cisplatin by reactivating endocytosis. *Proc. Natl. Acad. Sci U. S. A.* **2010,** *107* (16), 7449-7454.
Liu, J. B.; Hu, X. N.; Hou, S.; Wen, T.; Liu, W. Q.; Zhu, X.; Yin, J. J.; Wu, X. C. Au@Pt core/shell nanorods with peroxidase- and ascorbate oxidase-like activities for improved detection of glucose. *Sensors and Actuators B-Chemical* **2012,** *166*, 708-714.
Mahmood, M.; Xu, Y.; Dantuluri, V.; Mustafa, T.; Zhang, Y.; Karmakar, A.; Casciano, D.; Ali, S.; Biris, A. Carbon nanotubes enhance the internalization of drugs by cancer cells and decrease their chemoresistance to cytostatics. *Nanotechnology.* **2013,** *24* (4), 045102.
Mossoba, M. M.; Al-Khaldi, S. F.; Schoen, B.; Yakes, B. J. Nanoparticle probes and mid-infrared chemical imaging for DNA microarray detection. *Appl. Spectrosc.* **2010,** *64* (11), 1191-1198.
Mossoba, M. M.; Chizhikov, V.; Volokhov, D. V.; Martinez-Diaz, M. K.; Schoen, B.; Al-Khaldi, S. F. Identification of Mycoplasmas using a fluorophore-free microarray and infrared chemical imaging (IRCI). *J Microbiol. Methods* **2011,** *86* (3), 383-386.
Narayan, R.; Goering, P. Laser micro- and nanofabrication of biomaterials. *MRS Bulletin* **2011,** *36* (12), 973-982.
Ray, P. C.; Yu, H.; Fu, P. P. Nanogold-based sensing of environmental toxins: excitement and challenges. *J Environ Sci Health C. Environ Carcinog. Ecotoxicol. Rev.* **2011,** *29* (1), 52-89.
Sapsford, K. E.; Spindel, S.; Jennings, T.; Tao, G.; Triulzi, R. C.; Algar, W. R.; Medintz, I. L. Optimizing two-color semiconductor nanocrystal immunoassays in single well microtiter plate formats. *Sensors. (Basel. )* **2011,** *11* (8), 7879-7891.
Sharma, H. S.; Ali, S. F.; Dong, W.; Tian, Z. R.; Patnaik, R.; Patnaik, S.; Sharma, A.; Boman, A.; Lek, P.; Seifert, E.; Lundstedt, T. Drug delivery to the spinal cord tagged with nanowire enhances neuroprotective efficacy and functional recovery following trauma to the rat spinal cord. *Ann. N. Y. Acad. Sci* **2007,** *1122* , 197-218.
Sharma, H. S.; Ali, S. F.; Tian, Z. R.; Patnaik, R.; Patnaik, S.; Sharma, A.; Boman, A.; Lek, P.; Seifert, E.; Lundstedt, T. Nanowired-drug delivery enhances neuroprotective efficacy of compounds and reduces spinal cord edema formation and improves functional outcome following spinal cord injury in the rat. *Acta Neurochir. Suppl.* **2010,** *106*, 343-350.
Sun, S.; Yang, M.; Kostov, Y.; Rasooly, A. ELISA-LOC: lab-on-a-chip for enzyme-linked immunodetection. *Lab. Chip.* **2010,** *10* (16), 2093-2100.
Tang, S.; Zhao, J.; Storhoff, J. J.; Norris, P. J.; Little, R. F.; Yarchoan, R.; Stramer, S. L.; Patno, T.; Domanus, M.; Dhar, A.; Mirkin, C. A.; Hewlett, I. K. Nanoparticle-Based biobarcode amplification assay (BCA) for sensitive and early detection of human immunodeficiency type 1 capsid (p24) antigen. *J Acquir. Immune. Defic. Syndr.* **2007,** *46* (2), 231-237.
Tang, S.; Zhao, J.; Wang, A.; Viswanath, R.; Harma, H.; Little, R. F.; Yarchoan, R.; Stramer, S. L.; Nyambi, P. N.; Lee, S.; Wood, O.; Wong, E. Y.; Wang, X.; Hewlett, I. K. Characterization of immune responses to capsid protein p24 of human immunodeficiency virus type 1 and implications for detection. *Clin. Vaccine. Immunol.* **2010,** *17* (8), 1244-1251.
Tang, S.; Hewlett, I. Nanoparticle-based immunoassays for sensitive and early detection of HIV-1 capsid (p24) antigen. *J Infect. Dis* **2010,** *201 Suppl 1*, S59-S64.
Teeparuksapun, K.; Hedstrom, M.; Wong, E. Y.; Tang, S.; Hewlett, I. K.; Mattiasson, B. Ultrasensitive detection of HIV-1 p24 antigen using nanofunctionalized surfaces in a capacitive immunosensor. *Anal. Chem*  **2010,** *82* (20), 8406-8411.
Trickler, W. J.; Munt, D. J.; Jain, N.; Joshi, S. S.; Dash, A. K. Antitumor efficacy, tumor distribution and blood pharmacokinetics of chitosan/glyceryl-monooleate nanostructures containing paclitaxel. *Nanomedicine. (Lond. )* **2011,** *6* (3), 437-448.
Xu, Y.; Karmakar, A.; Heberlein, W. E.; Mustafa, T.; Biris, A. R.; Biris, A. S. Multifunctional magnetic nanoparticles for synergistic enhancement of cancer treatment by combinatorial radio frequency thermolysis and drug delivery. *Adv. Healthc. Mater.* **2012,** *1* (4), 493-501.
Xu, Y.; Karmakar, A.; Wang, D.; Mahmood, M. W.; Watanabe, F.; Zhang, Y.; Fejleh, A.; Fejleh, P.; Li, Z.; Kannarpady, G.; Ali, S.; Biris, A. R.; Biris, A. S. Multifunctional Fe3O4 Cored Magnetic-Quantum Dot Fluorescent Nanocomposites for RF Nanohyperthermia of Cancer Cells. *J. Phys. Chem. C* **2010,** *114* (11), 5020-5026.
Yang, M.; Kostov, Y.; Bruck, H. A.; Rasooly, A. Carbon nanotubes with enhanced chemiluminescence immunoassay for CCD-based detection of Staphylococcal enterotoxin B in food. *Anal. Chem* **2008,** *80* (22), 8532-8537.
Yang, M.; Kostov, Y.; Bruck, H. A.; Rasooly, A. Gold nanoparticle-based enhanced chemiluminescence immunosensor for detection of Staphylococcal Enterotoxin B (SEB) in food. *Int J Food Microbiol.* **2009,** *133* (3), 265-271.
Yang, M.; Bruck, H. A.; Kostov, Y.; Rasooly, A. Biological semiconductor based on electrical percolation. *Anal. Chem* **2010,** *82* (9), 3567-3572.
Yang, M.; Sun, S.; Bruck, H. A.; Kostov, Y.; Rasooly, A. Electrical percolation-based biosensor for real-time direct detection of staphylococcal enterotoxin B (SEB). *Biosens. Bioelectron.* **2010,** *25* (12), 2573-2578.
Yang, M.; Sun, S.; Kostov, Y.; Rasooly, A. Lab-On-a-Chip for carbon nanotubes based immunoassay detection of Staphylococcal Enterotoxin B (SEB). *Lab Chip* **2010,** *10* (8), 1011-1017.
Yang, M.; Sun, S.; Bruck, H. A.; Kostov, Y.; Rasooly, A. Lab-on-a-chip for label free biological semiconductor analysis of staphylococcal enterotoxin B. *Lab Chip* **2010,** *10* (19), 2534-2540.
Yang, M.; Sun, S.; Kostov, Y.; Rasooly, A. A simple 96 well microfluidic chip combined with visual and densitometry detection for resource-poor point of care testing. *Sens. Actuators. B Chem* **2011,** *153* (1), 176-181.
Yin, J. J.; Lao, F.; Meng, J.; Fu, P. P.; Zhao, Y.; Xing, G.; Gao, X.; Sun, B.; Wang, P. C.; Chen, C.; Liang, X. J. Inhibition of tumor growth by endohedral metallofullerenol nanoparticles optimized as reactive oxygen species scavenger. *Mol Pharmacol* **2008,** *74* (4), 1132-1140.
Yin, J. J.; Lao, F.; Fu, P. P.; Wamer, W. G.; Zhao, Y.; Wang, P. C.; Qiu, Y.; Sun, B.; Xing, G.; Dong, J.; Liang, X. J.; Chen, C. The scavenging of reactive oxygen species and the potential for cell protection by functionalized fullerene materials. *Biomaterials.* **2009,** *30* (4), 611-621.
Zhang, K.; Hu, X.; Liu, J.; Yin, J. J.; Hou, S.; Wen, T.; He, W.; Ji, Y.; Guo, Y.; Wang, Q.; Wu, X. Formation of PdPt alloy nanodots on gold nanorods: tuning oxidase-like activities via composition. *Langmuir*  **2011,** *27* (6), 2796-2803.
Zhao, B.; Yin, J. J.; Bilski, P. J.; Chignell, C. F.; Roberts, J. E.; He, Y. Y. Enhanced photodynamic efficacy towards melanoma cells by encapsulation of Pc4 in silica nanoparticles. *Toxicol Appl. Pharmacol* **2009,** *241* (2), 163-172.
Zhao, J.; Tang, S.; Storhoff, J.; Marla, S.; Bao, Y. P.; Wang, X.; Wong, E. Y.; Ragupathy, V.; Ye, Z.; Hewlett, I. K. Multiplexed, rapid detection of H5N1 using a PCR-free nanoparticle-based genomic microarray assay. *BMC Biotechnol.* **2010,** *10*, 74.
Zhao, K.; Zhang, L.; Wang, J.; Li, Q.; He, W.; Yin, J. J. Surface Structure-Dependent Molecular Oxygen Activation of BiOCl Single-Crystalline Nanosheets. *J. Am. Chem. Soc.* **2013,** *135* (42), 15750-15753.
Zidan, A. S.; Sammour, O. A.; Hammad, M. A.; Megrab, N. A.; Hussain, M. D.; Khan, M. A.; Habib, M. J. Formulation of anastrozole microparticles as biodegradable anticancer drug carriers. *AAPS PharmSciTech* **2006,** *7* (3), 61.
Characterization
Dair BJ; Tyner KM; Sapsford KE Techniques for the characterization of nanoparticle-bioconjugates. In *Methods in Bioengineering: Nanoscale Bioengineering and Nanomedicine*, Rege, K., Medintz, I. L., Eds.; Artech House: Norwood, MA, **2009**.
Guha, S.; Pease, L. F., III; Brorson, K. A.; Tarlov, M. J.; Zachariah, M. R. Evaluation of electrospray differential mobility analysis for virus particle analysis: Potential applications for biomanufacturing. *J Virol. Methods* **2011,** *178* (1-2), 201-208.
He, W. W.; Liu, Y. T.; Wamer, W. G.; Yin, J. J. Electron spin resonance spectroscopy for the study of nanomaterial-mediated generation of reactive oxygen species. *Journal of Food and Drug Analysis* **2014,** *22* (1), 49-63.
Jun-Jie, Y.; Baozhong, Z.; Qingsu, X.; Peter, P. F. Electron Spin Resonance Spectroscopy for Studying the Generation and Scavenging of Reactive Oxygen Species by Nanomaterials. In *Nanopharmaceutics*, WORLD SCIENTIFIC: **2012**; pp 375-400.
Keene, A.; Tyner, K. Analytical characterization of gold nanoparticle primary particles, aggregates, agglomerates, and agglomerated aggregates. *J Nanopart Res* **2011,** *13* (8), 3465-3481.
Rahman, Z.; Zidan, A. S.; Khan, M. A. Non-destructive methods of characterization of risperidone solid lipid nanoparticles. *Eur. J Pharm Biopharm.* **2010,** *76* (1), 127-137.
Sanchez-Pomales, G.; Mudalige, T. K.; Lim, J. H.; Linder, S. W. Rapid Determination of Silver in Nanobased Liquid Dietary Supplements Using a Portable X-ray Fluorescence Analyzer. *J. Agric. Food Chem.* **2013,** *61* (30), 7250-7257.
Shah, R. B.; Yang, Y.; Khan, M. A.; Faustino, P. J. Molecular weight determination for colloidal iron by Taguchi optimized validated gel permeation chromatography. *Int J Pharm* **2008,** *353* (1-2), 21-27.
Shah, R. B.; Yang, Y.; Khan, M. A.; Raw, A.; Yu, L. X.; Faustino, P. J. Pharmaceutical characterization and thermodynamic stability assessment of a colloidal iron drug product: iron sucrose. *Int J Pharm* **2014,** *464* (1-2), 46-52.
Shah, R. B.; Zidan, A. S.; Funck, T.; Tawakkul, M. A.; Nguyenpho, A.; Khan, M. A. Quality by design: characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology. *Int J Pharm* **2007,** *341* (1-2), 189-194.
Tsai, D. H.; Delrio, F. W.; Keene, A. M.; Tyner, K. M.; Maccuspie, R. I.; Cho, T. J.; Zachariah, M. R.; Hackley, V. A. Adsorption and conformation of serum albumin protein on gold nanoparticles investigated using dimensional measurements and in situ spectroscopic methods. *Langmuir.* **2011,** *27* (6), 2464-2477.
Tsai, D. H.; Elzey, S.; Delrio, F. W.; Keene, A. M.; Tyner, K. M.; Clogston, J. D.; Maccuspie, R. I.; Guha, S.; Zachariah, M. R.; Hackley, V. A. Tumor necrosis factor interaction with gold nanoparticles. *Nanoscale.* **2012,** *4* (10), 3208-3217.
Tyner, K. M.; Wokovich, A. M.; Doub, W. H.; Buhse, L. F.; Sung, L. P.; Watson, S. S.; Sadrieh, N. Comparing methods for detecting and characterizing metal oxide nanoparticles in unmodified commercial sunscreens. *Nanomedicine (Lond. )* **2009,** *4* (2), 145-159.
Zidan, A. S.; Rahman, Z.; Habib, M. J.; Khan, M. A. Spectral and spatial characterization of protein loaded PLGA nanoparticles. *J Pharm Sci* **2010,** *99* (3), 1180-1192.
Zook, J. M.; Rastogi, V.; Maccuspie, R. I.; Keene, A. M.; Fagan, J. Measuring agglomerate size distribution and dependence of localized surface plasmon resonance absorbance on gold nanoparticle agglomerate size using analytical ultracentrifugation. *ACS. Nano* **2011,** *5* (10), 8070-8079.
Effects
Austin, C. A.; Umbreit, T. H.; Brown, K. M.; Barber, D. S.; Dair, B. J.; Francke-Carroll, S.; Feswick, A.; Saint-Louis, M. A.; Hikawa, H.; Siebein, K. N.; Goering, P. L. Distribution of silver nanoparticles in pregnant mice and developing embryos. *Nanotoxicology.* **2012,** *6*, 912-922.
Butler, K. S.; Casey, B. J.; Garborcauskas, G. V. M.; Dair, B. J.; Elespuru, R. K. Assessment of titanium dioxide nanoparticle effects in bacteria: Association, uptake, mutagenicity, co-mutagenicity and DNA repair inhibition. *Mutation Research/Genetic Toxicology and Environmental Mutagenesis* **2014,** *768* (0), 14-22.
Chen, T.; Yan, J.; Li, Y. Genotoxicity of titanium dioxide nanoparticles. *Journal of Food and Drug Analysis* **2014,** *22* (1), 95-104.
Chiang, H. M.; Xia, Q.; Zou, X.; Wang, C.; Wang, S.; Miller, B. J.; Howard, P. C.; Yin, J. J.; Beland, F. A.; Yu, H.; Fu, P. P. Nanoscale ZnO induces cytotoxicity and DNA damage in human cell lines and rat primary neuronal cells. *J Nanosci. Nanotechnol.* **2012,** *12* (3), 2126-2135.
Choi, J.; Zhang, Q.; Reipa, V.; Wang, N. S.; Stratmeyer, M. E.; Hitchins, V. M.; Goering, P. L. Comparison of cytotoxic and inflammatory responses of photoluminescent silicon nanoparticles with silicon micron-sized particles in RAW 264.7 macrophages. *J Appl. Toxicol* **2009,** *29* (1), 52-60.
Choi, J.; Reipa, V.; Hitchins, V. M.; Goering, P. L.; Malinauskas, R. A. Physicochemical characterization and in vitro hemolysis evaluation of silver nanoparticles. *Toxicol Sci* **2011,** *123* (1), 133-143.
De Paoli, S. H.; Diduch, L. L.; Tegegn, T. Z.; Orecna, M.; Strader, M. B.; Karnaukhova, E.; Bonevich, J. E.; Holada, K.; Simak, J. The effect of protein corona composition on the interaction of carbon nanotubes with human blood platelets. *Biomaterials* **2014,** *35* (24), 6182-6194.
Dobrovolskaia, M. A.; Patri, A. K.; Simak, J.; Hall, J. B.; Semberova, J.; De Paoli Lacerda, S. H.; Mcneil, S. E. Nanoparticle size and surface charge determine effects of PAMAM dendrimers on human platelets in vitro. *Mol Pharm* **2012,** *9* (3), 382-393.
Fu, P. P.; Xia, Q.; Hwang, H. M.; Ray, P. C.; Yu, H. Mechanisms of nanotoxicity: Generation of reactive oxygen species. *Journal of Food and Drug Analysis* **2014,** *22* (1), 64-75.
Gao, Y.; Gopee, N. V.; Howard, P. C.; Yu, L. R. Proteomic analysis of early response lymph node proteins in mice treated with titanium dioxide nanoparticles. *J Proteomics.* **2011,** *74* (12), 2745-2759.
Ge, C. C.; Li, Y.; Yin, J. J.; Liu, Y.; Wang, L. M.; Zhao, Y. L.; Chen, C. Y. The contributions of metal impurities and tube structure to the toxicity of carbon nanotube materials. *Npg Asia Materials* **2012,** *4*.
Gelderman-Fuhrmann, M. P.; Simakova, O.; Carter, L. B.; Simak, J. Evaluation of immunophenotypes and activities of cell membrane microparticles in apheresis platelets: Impact of seven day storage. *Blood* **2005,** *106* (11), 537A-538A.
Gelderman-Fuhrmann, M. P.; Schiffmann, R.; Simak, J. Elevated counts of circulating endothelial microparticles in pediatric Fabry patients decreased after enzyme replacement therapy. *Blood* **2006,** *108* (11), 515A.
Gelderman, M. P.; Carter, L. B.; Simak, J. High counts of potentially pathogenic cell membrane microparticles in Apheresis platelets. *Blood* **2004,** *104* (11), 988A-989A.
Gelderman, M. P.; Simakova, O.; Clogston, J. D.; Patri, A. K.; Siddiqui, S. F.; Vostal, A. C.; Simak, J. Adverse effects of fullerenes on endothelial cells: fullerenol C60(OH)24 induced tissue factor and ICAM-I membrane expression and apoptosis in vitro. *Int J Nanomedicine.* **2008,** *3* (1), 59-68.
Genter, M. B.; Newman, N. C.; Shertzer, H. G.; Ali, S. F.; Bolon, B. Distribution and systemic effects of intranasally administered 25 nm silver nanoparticles in adult mice. *Toxicol Pathol* **2012,** *40* (7), 1004-1013.
Gonzalez, C.; Salazar-Garcia, S.; Palestino, G.; Martinez-Cuevas, P. P.; Ramirez-Lee, M. A.; Jurado-Manzano, B. B.; Rosas-Hernandez, H.; Gaytan-Pacheco, N.; Martel, G.; Espinosa-Tanguma, R.; Biris, A. S.; Ali, S. F. Effect of 45 nm silver nanoparticles (AgNPs) upon the smooth muscle of rat trachea: role of nitric oxide. *Toxicol Lett.* **2011,** *207* (3), 306-313.
Gopee, N. V.; Roberts, D. W.; Webb, P.; Cozart, C. R.; Siitonen, P. H.; Warbritton, A. R.; Yu, W. W.; Colvin, V. L.; Walker, N. J.; Howard, P. C. Migration of intradermally injected quantum dots to sentinel organs in mice. *Toxicol Sci* **2007,** *98* (1), 249-257.
Gopee, N. V.; Roberts, D. W.; Webb, P.; Cozart, C. R.; Siitonen, P. H.; Latendresse, J. R.; Warbitton, A. R.; Yu, W. W.; Colvin, V. L.; Walker, N. J.; Howard, P. C. Quantitative determination of skin penetration of PEG-coated CdSe quantum dots in dermabraded but not intact SKH-1 hairless mouse skin. *Toxicol Sci* **2009,** *111* (1), 37-48.
He, W.; Zhou, Y. T.; Wamer, W. G.; Hu, X.; Wu, X.; Zheng, Z.; Boudreau, M. D.; Yin, J. J. Intrinsic catalytic activity of Au nanoparticles with respect to hydrogen peroxide decomposition and superoxide scavenging. *Biomaterials.* **2013,** *34* (3), 765-773.
He, W. W.; Zhou, Y. T.; Wamer, W. G.; Boudreau, M. D.; Yin, J. J. Mechanisms of the pH dependent generation of hydroxyl radicals and oxygen induced by Ag nanoparticles. *Biomaterials* **2012,** *33* (30), 7547-7555.
Hunt, P. R.; Marquis, B. J.; Tyner, K. M.; Conklin, S.; Olejnik, N.; Nelson, B. C.; Sprando, R. L. Nanosilver suppresses growth and induces oxidative damage to DNA in Caenorhabditis elegans. *J. Appl. Toxicol.* **2013,** *33* (10), 1131-1142.
Hussain, S. M.; Javorina, A. K.; Schrand, A. M.; Duhart, H. M.; Ali, S. F.; Schlager, J. J. The interaction of manganese nanoparticles with PC-12 cells induces dopamine depletion. *Toxicol Sci* **2006,** *92* (2), 456-463.
Keene, A. M.; Allaway, R. J.; Sadrieh, N.; Tyner, K. M. Gold nanoparticle trafficking of typically excluded compounds across the cell membrane in JB6 Cl 41-5a cells causes assay interference. *Nanotoxicology.*  **2011,** *5* (4), 469-478.
Keene, A. M.; Peters, D.; Rouse, R.; Stewart, S.; Rosen, E. T.; Tyner, K. M. Tissue and cellular distribution of gold nanoparticles varies based on aggregation/agglomeration status. *Nanomedicine. (Lond. )* **2012,** *7* (2), 199-209.
Lacerda, S. H.; Park, J. J.; Meuse, C.; Pristinski, D.; Becker, M. L.; Karim, A.; Douglas, J. F. Interaction of gold nanoparticles with common human blood proteins. *ACS. Nano* **2010,** *4* (1), 365-379.
Lacerda, S. H.; Semberova, J.; Holada, K.; Simakova, O.; Simak, J. Carbon Nanotubes Activate Store Operated Calcium Entry (SOCE) In Human Platelets Manifested by STIM1 Capping. *Blood* **2010,** *116* (21), 1311.
Lacerda, S. H.; Semberova, J.; Holada, K.; Simakova, O.; Hudson, S. D.; Simak, J. Carbon nanotubes activate store-operated calcium entry in human blood platelets. *ACS. Nano* **2011,** *5* (7), 5808-5813.
Li, M.; Yin, J. J.; Wamer, W. G.; Lo, Y. M. Mechanistic characterization of titanium dioxide nanoparticle-induced toxicity using electron spin resonance. *Journal of Food and Drug Analysis* **2014,** *22* (1), 76-85.
Li, Y.; Bhalli, J. A.; Ding, W.; Yan, J.; Pearce, M. G.; Sadiq, R.; Cunningham, C. K.; Jones, M. Y.; Monroe, W. A.; Howard, P. C.; Zhou, T.; Chen, T. Cytotoxicity and genotoxicity assessment of silver nanoparticles in mouse. *Nanotoxicology.* **2014,** *8 Suppl 1*, 36-45.
Li, Y.; Chen, D. H.; Yan, J.; Chen, Y.; Mittelstaedt, R. A.; Zhang, Y.; Biris, A. S.; Heflich, R. H.; Chen, T. Genotoxicity of silver nanoparticles evaluated using the Ames test and in vitro micronucleus assay. *Mutation Research/Genetic Toxicology and Environmental Mutagenesis* **2012,** *745* (1-2), 4-10.
Ma, X. W.; Zhang, L. H.; Wang, L. R.; Xue, X.; Sun, J. H.; Wu, Y.; Zou, G. Z.; Wu, X.; Wang, P. C.; Wamer, W. G.; Yin, J. J.; Zheng, K. Y.; Liang, X. J. Single-Walled Carbon Nanotubes Alter Cytochrome c Electron Transfer and Modulate Mitochondrial Function. *ACS. Nano* **2012,** *6* (12), 10486-10496.
Mahmood, M.; Li, Z.; Casciano, D.; Khodakovskaya, M. V.; Chen, T.; Karmakar, A.; Dervishi, E.; Xu, Y.; Mustafa, T.; Watanabe, F.; Fejleh, A.; Whitlow, M.; Al-Adami, M.; Ghosh, A.; Biris, A. S. Nanostructural materials increase mineralization in bone cells and affect gene expression through miRNA regulation. *J Cell. Mol Med* **2011,** *15* (11), 2297-2306.
Mei, N.; Zhang, Y.; Chen, Y.; Guo, X.; Ding, W.; Ali, S. F.; Biris, A. S.; Rice, P.; Moore, M. M.; Chen, T. Silver nanoparticle-induced mutations and oxidative stress in mouse lymphoma cells. *Environ. Mol. Mutagen.* **2012,** *53* (6), 409-419.
Oh, E.; Delehanty, J. B.; Sapsford, K. E.; Susumu, K.; Goswami, R.; Blanco-Canosa, J. B.; Dawson, P. E.; Granek, J.; Shoff, M.; Zhang, Q.; Goering, P. L.; Huston, A.; Medintz, I. L. Cellular uptake and fate of PEGylated gold nanoparticles is dependent on both cell-penetration peptides and particle size. *ACS. Nano* **2011,** *5* (8), 6434-6448.
Orecna, M.; De Paoli, S. H.; Janouskova, O.; Tegegn, T. Z.; Filipova, M.; Bonevich, J. E.; Holada, K.; Simak, J.  Toxicity of carboxylated carbon nanotubes in endothelial cells is attenuated by stimulation of the autophagic flux with the release of nanomaterial in autophagic vesicles. Nanomedicine : nanotechnology, biology, and medicine. 2-24-**2014**. Ref Type: Abstract
Patri, A.; Umbreit, T.; Zheng, J.; Nagashima, K.; Goering, P.; Francke-Carroll, S.; Gordon, E.; Weaver, J.; Miller, T.; Sadrieh, N.; McNeil, S.; Stratmeyer, M. Energy dispersive X-ray analysis of titanium dioxide nanoparticle distribution after intravenous and subcutaneous injection in mice. *J Appl. Toxicol* **2009,** *29* (8), 662-672.
Prabhu, B. M.; Ali, S. F.; Murdock, R. C.; Hussain, S. M.; Srivatsan, M. Copper nanoparticles exert size and concentration dependent toxicity on somatosensory neurons of rat. *Nanotoxicology.* **2010,** *4* (2), 150-160.
Rahman, M. F.; Wang, J.; Patterson, T. A.; Saini, U. T.; Robinson, B. L.; Newport, G. D.; Murdock, R. C.; Schlager, J. J.; Hussain, S. M.; Ali, S. F. Expression of genes related to oxidative stress in the mouse brain after exposure to silver-25 nanoparticles. *Toxicol Lett.* **2009,** *187* (1), 15-21.
Ray, P. C.; Rosas-Hernandez, H.; Rosas-Hernandez, H. Ã.; Salazar-Garcia, S.; Gutierrez-Hernandez, J. M.; Espinosa-Tanguma, R.; Gonzalez, F. J.; Ali, S. F.; Gonzalez, C. Silver nanoparticles induce anti-proliferative effects on airway smooth muscle cells. Role of nitric oxide and muscarinic receptor signaling pathway. *Toxicology Letters* **2014,** *224* (2), 246-256.
Rosas-Hernandez, H.; Jimenez-Badillo, S.; Martinez-Cuevas, P. P.; Gracia-Espino, E.; Terrones, H.; Terrones, M.; Hussain, S. M.; Ali, S. F.; Gonzalez, C. Effects of 45-nm silver nanoparticles on coronary endothelial cells and isolated rat aortic rings. *Toxicol Lett.* **2009,** *191* (2-3), 305-313.
Sadiq, R.; Bhalli, J. A.; Yan, J.; Woodruff, R. S.; Pearce, M. G.; Li, Y.; Mustafa, T.; Watanabe, F.; Pack, L. M.; Biris, A. S.; Khan, Q. M.; Chen, T. Genotoxicity of TiO(2) anatase nanoparticles in B6C3F1 male mice evaluated using Pig-a and flow cytometric micronucleus assays. *Mutat. Res* **2012,** *745* (1-2), 65-72.
Sadrieh, N.; Wokovich, A. M.; Gopee, N. V.; Zheng, J.; Haines, D.; Parmiter, D.; Siitonen, P. H.; Cozart, C. R.; Patri, A. K.; Mcneil, S. E.; Howard, P. C.; Doub, W. H.; Buhse, L. F. Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles. *Toxicol Sci* **2010,** *115* (1), 156-166.
Sahu, S. C.; Njoroge, J.; Bryce, S. M.; Yourick, J. J.; Sprando, R. L. Comparative genotoxicity of nanosilver in human liver HepG2 and colon Caco2 cells evaluated by a flow cytometric in vitro micronucleus assay. *J. Appl. Toxicol.* **2014,** *34*  (11), 1226-1234.
Sahu, S. C.; Roy, S.; Zheng, J.; Yourick, J. J.; Sprando, R. L. Comparative genotoxicity of nanosilver in human liver HepG2 and colon Caco2 cells evaluated by fluorescent microscopy of cytochalasin B-blocked micronucleus formation. *J. Appl. Toxicol.* **2014,** n/a.
Sahu, S. C.; Zheng, J.; Graham, L.; Chen, L.; Ihrie, J.; Yourick, J. J.; Sprando, R. L. Comparative cytotoxicity of nanosilver in human liver HepG2 and colon Caco2 cells in culture. *J. Appl. Toxicol.* **2014,** n/a.
Semberova, J.; Holada, K.; Simakova, O.; Gelderman-Fuhrmann, M. P.; Simak, J. Carbon Nanotubes Activate Platelets by Facilitating Extracellular Ca2+ Influx. *Blood* **2008,** *112* (11), 365-366.
Semberova, J.; Lacerda, S. H. D. P.; Simakova, O.; Holada, K.; Gelderman, M. P.; Simak, J. Carbon Nanotubes Activate Blood Platelets by Inducing Extracellular Ca2+ Influx Sensitive to Calcium Entry Inhibitors. *Nano Letters* **2009,** *9* (9), 3312-3317.
Sharma, H. S.; Ali, S. F.; Tian, Z. R.; Hussain, S. M.; Schlager, J. J.; Sjoquist, P. O.; Sharma, A.; Muresanu, D. F. Chronic treatment with nanoparticles exacerbate hyperthermia induced blood-brain barrier breakdown, cognitive dysfunction and brain pathology in the rat. Neuroprotective effects of nanowired-antioxidant compound H-290/51. *J Nanosci. Nanotechnol.* **2009,** *9* (8), 5073-5090.
Sharma, H. S.; Ali, S. F.; Hussain, S. M.; Schlager, J. J.; Sharma, A. Influence of engineered nanoparticles from metals on the blood-brain barrier permeability, cerebral blood flow, brain edema and neurotoxicity. An experimental study in the rat and mice using biochemical and morphological approaches. *J Nanosci. Nanotechnol.* **2009,** *9* (8), 5055-5072.
Sharma, H. S.; Hussain, S.; Schlager, J.; Ali, S. F.; Sharma, A. Influence of nanoparticles on blood-brain barrier permeability and brain edema formation in rats. *Acta Neurochir. Suppl.* **2010,** *106*, 359-364.
Simak, J. Nanotoxicity in blood: Effects of engineered nanomaterials on platelets. In ***Nanotoxicity: From In Vivo and In Vitro Models to Health Risks***, Sahu, S. C., Casciano, D. A., Eds.; John Wiley and Sons: 2009.
Simak, J. The Effects of Engineered Nanomaterials on Platelets. In *Handbook of Immunological Properties of Engineered Nanomaterials*, Volume 1 ed.; Dobrovolskaia, M. A., McNeil, S., Eds.; WORLD SCIENTIFIC: **2012**; pp 293-356.
Simak, J. The Effects of Engineered Nanomaterials on the Plasma Coagulation System. In *Handbook of Immunological Properties of Engineered Nanomaterials*, Volume 1 ed.; Dobrovolskaia, M. A., McNeil, S., Eds.; WORLD SCIENTIFIC: **2012**; pp 263-291.
Simak, J. The Effects of Engineered Nanomaterials on Cultured Endothelial Cells. In *Handbook of Immunological Properties of Engineered Nanomaterials*, Volume 1 ed.; Dobrovolskaia, M. A., McNeil, S., Eds.; WORLD SCIENTIFIC: **2012**; pp 207-261.
Trickler, W. J.; Lantz, S. M.; Murdock, R. C.; Schrand, A. M.; Robinson, B. L.; Newport, G. D.; Schlager, J. J.; Oldenburg, S. J.; Paule, M. G.; Slikker, W., Jr.; Hussain, S. M.; Ali, S. F. Silver nanoparticle induced blood-brain barrier inflammation and increased permeability in primary rat brain microvessel endothelial cells. *Toxicol Sci* **2010,** *118* (1), 160-170.
Trickler, W. J.; Lantz, S. M.; Murdock, R. C.; Schrand, A. M.; Robinson, B. L.; Newport, G. D.; Schlager, J. J.; Oldenburg, S. J.; Paule, M. G.; Slikker, W., Jr.; Hussain, S. M.; Ali, S. F. Brain microvessel endothelial cells responses to gold nanoparticles: In vitro pro-inflammatory mediators and permeability. *Nanotoxicology.* **2011,** *5* (4), 479-492.
Trickler, W. J.; Lantz, S. M.; Schrand, A. M.; Robinson, B. L.; Newport, G. D.; Schlager, J. J.; Paule, M. G.; Slikker, W.; Biris, A. S.; Hussain, S. M.; Ali, S. F. Effects of copper nanoparticles on rat cerebral microvessel endothelial cells. *Nanomedicine. (Lond. )* **2012,** *7* (6), 835-846.
Trickler, W. J.; Lantz-McPeak, S. M.; Robinson, B. L.; Paule, M. G.; Slikker, W., Jr.; Biris, A. S.; Schlager, J. J.; Hussain, S. M.; Kanungo, J.; Gonzalez, C.; Ali, S. F. Porcine brain microvessel endothelial cells show pro-inflammatory response to the size and composition of metallic nanoparticles. *Drug Metab. Rev.* **2014,** *46* (2), 224-231.
Umbreit, T. H.; Francke-Carroll, S.; Weaver, J. L.; Miller, T. J.; Goering, P. L.; Sadrieh, N.; Stratmeyer, M. E. Tissue distribution and histopathological effects of titanium dioxide nanoparticles after intravenous or subcutaneous injection in mice. *J Appl. Toxicol* **2012,** *32* (5), 350-357.
Wamer, W. G.; Yin, J. J. Photocytotoxicity in human dermal fibroblasts elicited by permanent makeup inks containing titanium dioxide. *J Cosmet. Sci* **2011,** *62* (6), 535-547.
Wang, B.; Yin, J. J.; Zhou, X. Y.; Kurash, I.; Chai, Z. F.; Zhao, Y. L.; Feng, W. Y. Physicochemical Origin for Free Radical Generation of Iron Oxide Nanoparticles in Biomicroenvironment: Catalytic Activities Mediated by Surface Chemical States. *Journal of Physical Chemistry C* **2013,** *117* (1), 383-392.
Wang, C. C.; Wang, S. G.; Xia, Q. S.; He, W. W.; Yin, J. J.; Fu, P. P.; Li, J. H. Phototoxicity of Zinc Oxide Nanoparticles in HaCaT Keratinocytes-Generation of Oxidative DNA Damage During UVA and Visible Light Irradiation. *J Nanosci. Nanotechnol.* **2013,** *13* (6), 3880-3888.
Wang, J.; Rahman, M. F.; Duhart, H. M.; Newport, G. D.; Patterson, T. A.; Murdock, R. C.; Hussain, S. M.; Schlager, J. J.; Ali, S. F. Expression changes of dopaminergic system-related genes in PC12 cells induced by manganese, silver, or copper nanoparticles. *Neurotoxicology.* **2009,** *30* (6), 926-933.
Woodruff, R. S.; Li, Y.; Yan, J.; Bishop, M.; Jones, M. Y.; Watanabe, F.; Biris, A. S.; Rice, P.; Zhou, T.; Chen, T. Genotoxicity evaluation of titanium dioxide nanoparticles using the Ames test and Comet assay. *J. Appl. Toxicol.* **2012,** *32* (11), 934-943.
Wu, H. H.; Yin, J. J.; Wamer, W. G.; Zeng, M. Y.; Lo, Y. M. Reactive oxygen species-related activities of nano-iron metal and nano-iron oxides. *Journal of Food and Drug Analysis* **2014,** *22* (1), 86-94.
Yang, M.; Kwon, S.; Kostov, Y.; Rasooly, A.; Rao, G.; Ghosh, U. Study of the biouptake of labeled single-walled carbon nanotubes using fluorescence-based method. *Environ Chem Lett* **2011,** *9* (2), 235-241.
Yin, J. J.; Liu, J.; Ehrenshaft, M.; Roberts, J. E.; Fu, P. P.; Mason, R. P.; Zhao, B. Z. Phototoxicity of nano titanium dioxides in HaCaT keratinocytes-Generation of reactive oxygen species and cell damage. *Toxicol Appl. Pharmacol* **2012,** *263* (1), 81-88.
Zhang, Q.; Hitchins, V. M.; Schrand, A. M.; Hussain, S. M.; Goering, P. L. Uptake of gold nanoparticles in murine macrophage cells without cytotoxicity or production of pro-inflammatory mediators. *Nanotoxicology.* **2011,** *5* (3), 284-295.
Zhang, W. D.; Wang, C.; Li, Z. J.; Lu, Z. Z.; Li, Y. Y.; Yin, J. J.; Zhou, Y. T.; Gao, X. F.; Fang, Y.; Nie, G. J.; Zhao, Y. L. Unraveling Stress-Induced Toxicity Properties of Graphene Oxide and the Underlying Mechanism. *Advanced Materials* **2012,** *24* (39), 5391-5397.
Zhang, Y.; Ali, S. F.; Dervishi, E.; Xu, Y.; Li, Z.; Casciano, D.; Biris, A. S. Cytotoxicity effects of graphene and single-wall carbon nanotubes in neural phaeochromocytoma-derived PC12 cells. *ACS. Nano* **2010,** *4* (6), 3181-3186.
Zhang, Y.; Xu, Y.; Li, Z.; Chen, T.; Lantz, S. M.; Howard, P. C.; Paule, M. G.; Slikker, W., Jr.; Watanabe, F.; Mustafa, T.; Biris, A. S.; Ali, S. F. Mechanistic toxicity evaluation of uncoated and PEGylated single-walled carbon nanotubes in neuronal PC12 cells. *ACS. Nano* **2011,** *5* (9), 7020-7033.
Zhang, Y.; Ferguson, S. A.; Watanabe, F.; Jones, Y.; Xu, Y.; Biris, A. S.; Hussain, S.; Ali, S. F. Silver nanoparticles decrease body weight and locomotor activity in adult male rats. *Small.* **2013,** *9* (9-10), 1715-1720.
Zhao, B.; He, Y. Y.; Chignell, C. F.; Yin, J. J.; Andley, U.; Roberts, J. E. Difference in phototoxicity of cyclodextrin complexed fullerene [(gamma-CyD)2/C60] and its aggregated derivatives toward human lens epithelial cells. *Chem Res Toxicol* **2009,** *22* (4), 660-667.
Zhou, Y. T.; He, W. W.; Lo, Y. M.; Hu, X. N.; Wu, X. C.; Yin, J. J. Effect of Silver Nanomaterials on the Activity of Thiol-Containing Antioxidants. *J. Agric. Food Chem.* **2013,** *61* (32), 7855-7862.
Evaluation
Cruz, C. N.; Tyner, K. M.; Velazquez, L.; Hyams, K. C.; Jacobs, A.; Shaw, A. B.; Jiang, W.; Lionberger, R.; Hinderling, P.; Kong, Y.; Brown, P. C.; Ghosh, T.; Strasinger, C.; Suarez-Sharp, S.; Henry, D.; Van, U. M.; Sadrieh, N.; Morefield, E. CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products. *AAPS J* **2013,** *15* (3), 623-628.
Dair, B. J.; Saylor, D. M.; Cargal, T. E.; French, G. R.; Kennedy, K. M.; Casas, R. S.; Guyer, J. E.; Warren, J. A.; Kim, C. S.; Pollack, S. K. The effect of substrate material on silver nanoparticle antimicrobial efficacy. *J Nanosci. Nanotechnol.* **2010,** *10* (12), 8456-8462.
Dobrovolskaia, M. A.; Germolec, D. R.; Weaver, J. L. Evaluation of nanoparticle immunotoxicity. *Nat. Nanotechnol.* **2009,** *4* (7), 411-414.
Duncan, T. V. The communication challenges presented by nanofoods. *Nat. Nanotechnol.* **2011,** *6* (11), 683-688.
Guo, X.; Mei, N. Assessment of the toxic potential of graphene family nanomaterials. *Journal of Food and Drug Analysis* **2014,** *22* (1), 105-115.
Inselman, A. L.; Wang, C.; Liu, F.; Hansen, D. K. Stem Cells in Toxicity Testing. In *Handbook of Nanotoxicology, Nanomedicine and Stem Cell Use in Toxicology*, John Wiley & Sons, Ltd: **2014**; pp 251-266.
Jiang, W.; Lionberger, R.; Yu, L. X. In vitro and in vivo characterizations of PEGylated liposomal doxorubicin. *Bioanalysis.* **2011,** *3* (3), 333-344.
Li, Y.; Chen, T. Genotoxicity of Silver Nanoparticles*. In *Handbook of Nanotoxicology, Nanomedicine and Stem Cell Use in Toxicology*, John Wiley & Sons, Ltd: **2014**; pp 87-98.
Martinez, M. N. Factors influencing the use and interpretation of animal models in the development of parenteral drug delivery systems. *AAPS J* **2011,** *13* (4), 632-649.
Mu, L.; Sprando, R. L. Application of nanotechnology in cosmetics. *Pharm Res* **2010,** *27* (8), 1746-1749.
Pfuhler, S.; Elespuru, R.; Aardema, M. J.; Doak, S. H.; Maria Donner, E.; Honma, M.; Kirsch-Volders, M.; Landsiedel, R.; Manjanatha, M.; Singer, T.; Kim, J. H. Genotoxicity of nanomaterials: Refining strategies and tests for hazard identification. *Environ. Mol. Mutagen.* **2013,** *54* (4), 229-239.
Rahman, Z.; Zidan, A. S.; Habib, M. J.; Khan, M. A. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. *Int J Pharm* **2010,** *389* (1-2), 186-194.
Sadrieh, N.; Tyner, K. M. Nanotechnology and therapeutic delivery: a drug regulation perspective. *Ther. Deliv.* **2010,** *1* (1), 83-89.
Sapsford, K. E.; Tyner, K. M.; Dair, B. J.; Deschamps, J. R.; Medintz, I. L. Analyzing nanomaterial bioconjugates: a review of current and emerging purification and characterization techniques. *Anal. Chem* **2011,** *83* (12), 4453-4488.
Schrand, A. M.; Rahman, M. F.; Hussain, S. M.; Schlager, J. J.; Smith, D. A.; Syed, A. F. Metal-based nanoparticles and their toxicity assessment. *Wiley. Interdiscip. Rev. Nanomed. Nanobiotechnol.* **2010,** *2* (5), 544-568.
Silbergeld, E. K.; Contreras, E. Q.; Hartung, T.; Hirsch, C.; Hogberg, H.; Jachak, A. C.; Jordan, W.; Landsiedel, R.; Morris, J.; Patri, A.; Pounds, J. G.; de Vizcaya, R. A.; Shvedova, A.; Tanguay, R.; Tatarazako, N.; van, V. E.; Walker, N. J.; Wiesner, M.; Wilcox, N.; Zurlo, J. t(4) workshop report. Nanotoxicology: "the end of the beginning" - signs on the roadmap to a strategy for assuring the safe application and use of nanomaterials. *ALTEX.* **2011,** *28* (3), 236-241.
Simona, B.; Katherine, M. T.; James, L. W. Immunotoxicity Testing for Drug: Nanoparticle Conjugates: Regulatory Considerations. In *Handbook of Immunological Properties of Engineered Nanomaterials*, Volume 1 ed.; WORLD SCIENTIFIC: **2012**; pp 671-685.
Stratmeyer, M. E.; Goering, P. L.; Hitchins, V. M.; Umbreit, T. H. What we know and don't know about the bioeffects of nanoparticles: developing experimental approaches for safety assessment. *Biomed. Microdevices.* **2010,** *12* (4), 569-573.
Tyner, K. M.; Wokovich, A. M.; Godar, D. E.; Doub, W. H.; Sadrieh, N. The state of nano-sized titanium dioxide (TiO2) may affect sunscreen performance. *Int J Cosmet. Sci* **2011,** *33* (3), 234-244.
Tyner, K.; Sadrieh, N. Considerations When Submitting Nanotherapeutics to FDA/CDER for Regulatory Review. In *Characterization of Nanoparticles Intended for Drug Delivery*, 697 ed.; McNeil, S. E., Ed.; Humana Press: **2011**; pp 17-31.
Volpe, D. A.; Shaw, A. B.; Chen, X. H.; Zhou, L.; Chen, M. L. Effect of altered temperature storage on the in vitro cellular uptake of liposome drug products. *J Liposome. Res* **2010,** *20* (2), 178-182.
Xu, X.; Khan, M. A.; Burgess, D. J. A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment. *Int J Pharm* **2011,** *419* (1-2), 52-59.
Yang, Y.; Shah, R. B.; Faustino, P. J.; Raw, A.; Yu, L. X.; Khan, M. A. Thermodynamic stability assessment of a colloidal iron drug product: sodium ferric gluconate. *J Pharm Sci* **2010,**  *99* (1), 142-153.
Yin, J. J.; Fu, P. P.; Lutterodt, H.; Zhou, Y. T.; Antholine, W. E.; Wamer, W. Dual Role of Selected Antioxidants Found in Dietary Supplements: Crossover between Anti- and Pro-Oxidant Activities in the Presence of Copper. *J. Agric. Food Chem.* **2012,** *60* (10), 2554-2561.
Zhang, Y.; Petibone, D.; Xu, Y.; Mahmood, M.; Karmakar, A.; Casciano, D.; Ali, S.; Biris, A. S. Toxicity and efficacy of carbon nanotubes and graphene: the utility of carbon-based nanoparticles in nanomedicine. *Drug Metab. Rev.* **2014,** *46* (2), 232-246.
Zidan, A. S.; Sammour, O. A.; Hammad, M. A.; Megrab, N. A.; Habib, M. J.; Khan, M. A. Quality by design: understanding the product variability of a self-nanoemulsified drug delivery system of cyclosporine A. *J Pharm Sci* **2007,** *96* (9), 2409-2423.
Zidan, A. S.; Sammour, O. A.; Hammad, M. A.; Megrab, N. A.; Habib, M. J.; Khan, M. A. Quality by design: understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. *Int J Pharm* **2007,** *332* (1-2), 55-63.
Zolnik, B. S.; Sadrieh, N. Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs. *Adv. Drug Deliv. Rev.* **2009,** *61* (6), 422-427.
Zolnik, B. S.; Gonzalez-Fernandez, A.; Sadrieh, N.; Dobrovolskaia, M. A. Nanoparticles and the immune system. *Endocrinology.* **2010,** *151* (2), 458-465.

                                                                                  Content current as of:
      03/19/2018Nanotechnology Programs at FDA

          
                        Nanotechnology Guidance Documents
          Nanotechnology Task Force
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop