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A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.
- Published in:
- Annals of the New York Academy of Sciences, 2021, v. 1502, n. 1, p. 5, doi. 10.1111/nyas.14662
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- Publication type:
- Article
Repetitive Application of Sunscreen Containing Titanium Dioxide Nanoparticles on Human Skin.
- Published in:
- 2016
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- Publication type:
- journal article
Analysis of fullerene-based nanomaterial in serum matrix by CE.
- Published in:
- Electrophoresis, 2007, v. 28, n. 10, p. 1518, doi. 10.1002/elps.200600724
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- Article
The Utility of TEM and AFM Techniques in the Preclinical Assessment of Nanomaterials.
- Published in:
- 2010
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- Publication type:
- Abstract
Nanomedicines: addressing the scientific and regulatory gap.
- Published in:
- Annals of the New York Academy of Sciences, 2014, v. 1313, p. 35, doi. 10.1111/nyas.12403
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- Publication type:
- Article
Nanomedicines: addressing the scientific and regulatory gap.
- Published in:
- Annals of the New York Academy of Sciences, 2014, v. 1313, n. 1, p. 35, doi. 10.1111/nyas.12403
- By:
- Publication type:
- Article
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".
- Published in:
- AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0329-7
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- Publication type:
- Article
Induction of Autophagy in Porcine Kidney Cells by Quantum Dots: A Common Cellular Response to Nanomaterials?
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- Toxicological Sciences, 2008, v. 106, n. 1, p. 140, doi. 10.1093/toxsci/kfn137
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- Publication type:
- Article
Nanotechnology Safety Concerns Revisited.
- Published in:
- Toxicological Sciences, 2008, v. 101, n. 1, p. 4, doi. 10.1093/toxsci/kfm169
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- Publication type:
- Article
Common pitfalls in nanotechnology: lessons learned from NCI's Nanotechnology Characterization Laboratory.
- Published in:
- Integrative Biology, 2013, v. 5, n. 1, p. 66, doi. 10.1039/c2ib20117h
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- Publication type:
- Article
Nanomaterial standards for efficacy and toxicity assessment.
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- WIREs: Nanomedicine & Nanobiotechnology, 2010, v. 2, n. 1, p. 99, doi. 10.1002/wnan.66
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- Publication type:
- Article
Nanoparticle therapeutics: a personal perspective.
- Published in:
- WIREs: Nanomedicine & Nanobiotechnology, 2009, v. 1, n. 3, p. 264, doi. 10.1002/wnan.6
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- Publication type:
- Article
Anticoagulants Influence the Performance of In Vitro Assays Intended for Characterization of Nanotechnology-Based Formulations.
- Published in:
- Molecules, 2018, v. 23, n. 1, p. 12, doi. 10.3390/molecules23010012
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- Publication type:
- Article
Longitudinal Imaging of Cancer Cell Metastases in Two Preclinical Models: A Correlation of Noninvasive Imaging to Histopathology.
- Published in:
- International Journal of Molecular Imaging, 2014, p. 1, doi. 10.1155/2014/102702
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- Publication type:
- Article
Immunological properties of engineered nanomaterials.
- Published in:
- Nature Nanotechnology, 2007, v. 2, n. 8, p. 469, doi. 10.1038/nnano.2007.223
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- Publication type:
- Article
Lack of Significant Dermal Penetration of Titanium Dioxide from Sunscreen Formulations Containing Nano- and Submicron-Size TiO2 Particles.
- Published in:
- Toxicological Sciences, 2010, v. 115, n. 1, p. 156, doi. 10.1093/toxsci/kfq041
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- Publication type:
- Article