Nakissa Sadrieh

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles
    Nakissa Sadrieh
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Toxicol Sci 115:156-66. 2010
  2. doi request reprint The state of nano-sized titanium dioxide (TiO2) may affect sunscreen performance
    K M Tyner
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Int J Cosmet Sci 33:234-44. 2011
  3. doi request reprint Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapes
    Anna M Wokovich
    Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri, USA
    J Biomed Mater Res B Appl Biomater 87:105-13. 2008
  4. doi request reprint Particle size determination of sunscreens formulated with various forms of titanium dioxide
    Anna Wokovich
    Food and Drug Administration, Center for Drug Evaluation and Research, St Louis, MO 63101, USA
    Drug Dev Ind Pharm 35:1180-9. 2009
  5. pmc CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products
    Celia N Cruz
    Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    AAPS J 15:623-8. 2013
  6. ncbi request reprint Nanotechnology and therapeutic delivery: a drug regulation perspective
    Nakissa Sadrieh
    Center for Drug Evaluation and Research, US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    Ther Deliv 1:83-9. 2010
  7. doi request reprint Comparing methods for detecting and characterizing metal oxide nanoparticles in unmodified commercial sunscreens
    Katherine M Tyner
    Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA
    Nanomedicine (Lond) 4:145-59. 2009
  8. pmc Immunolocalization of Kim-1, RPA-1, and RPA-2 in kidney of gentamicin-, mercury-, or chromium-treated rats: relationship to renal distributions of iNOS and nitrotyrosine
    Jun Zhang
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Toxicol Pathol 36:397-409. 2008
  9. pmc Differences in immunolocalization of Kim-1, RPA-1, and RPA-2 in kidneys of gentamicin-, cisplatin-, and valproic acid-treated rats: potential role of iNOS and nitrotyrosine
    Jun Zhang
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 37:629-43. 2009
  10. doi request reprint Development of cardiac safety translational tools for QT prolongation and torsade de pointes
    Luis G Valerio
    Center for Drug Evaluation and Research, Division of Metabolism and Endocrinology Products, Office of New Drugs, U S Food and Drug Administration, Silver Spring, MD 20903, USA
    Expert Opin Drug Metab Toxicol 9:801-15. 2013

Collaborators

Detail Information

Publications20

  1. pmc Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles
    Nakissa Sadrieh
    Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Toxicol Sci 115:156-66. 2010
    ..At most, the few isolated particles represent a tiny fraction of the total amount of applied TiO(2). These findings indicate that there is no significant penetration of TiO(2) nanoparticles through the intact normal epidermis...
  2. doi request reprint The state of nano-sized titanium dioxide (TiO2) may affect sunscreen performance
    K M Tyner
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Int J Cosmet Sci 33:234-44. 2011
    ..This indicates that nanoscale TiO(2) may have better efficacy while lacking toxicity...
  3. doi request reprint Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapes
    Anna M Wokovich
    Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri, USA
    J Biomed Mater Res B Appl Biomater 87:105-13. 2008
    ..No substrate mimics cadaver skin for all five tapes. SS had the best ability to distinguish among the medical tapes. Overall, for quality control purposes (yielding good discrimination and precision), SS would be the optimal substrate...
  4. doi request reprint Particle size determination of sunscreens formulated with various forms of titanium dioxide
    Anna Wokovich
    Food and Drug Administration, Center for Drug Evaluation and Research, St Louis, MO 63101, USA
    Drug Dev Ind Pharm 35:1180-9. 2009
    ..Four sunscreen products were manufactured...
  5. pmc CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products
    Celia N Cruz
    Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    AAPS J 15:623-8. 2013
    ..This publication outlines the risk assessment and management process used by the working group, using nanomaterial API by the oral route of administration as an example. ..
  6. ncbi request reprint Nanotechnology and therapeutic delivery: a drug regulation perspective
    Nakissa Sadrieh
    Center for Drug Evaluation and Research, US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    Ther Deliv 1:83-9. 2010
    ..This regulatory focus highlights some current guidance documents and thinking of the FDA as applied to nanoparticles used for therapeutic delivery...
  7. doi request reprint Comparing methods for detecting and characterizing metal oxide nanoparticles in unmodified commercial sunscreens
    Katherine M Tyner
    Center for Drug Evaluation and Research, FDA, Silver Spring, MD 20993, USA
    Nanomedicine (Lond) 4:145-59. 2009
    ..To determine if commercial sunscreens contain distinct nanoparticles and to evaluate analytical methods for their ability to detect and characterize nanoparticles in unmodified topical products using commercial sunscreens as a model...
  8. pmc Immunolocalization of Kim-1, RPA-1, and RPA-2 in kidney of gentamicin-, mercury-, or chromium-treated rats: relationship to renal distributions of iNOS and nitrotyrosine
    Jun Zhang
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Toxicol Pathol 36:397-409. 2008
    ..It is possible that iNOS activation with nitrotyrosine production in injured nephron segments may be involved in the induction of Kim-1, RPA-1, and RPA-2 following exposure to nephrotoxicants...
  9. pmc Differences in immunolocalization of Kim-1, RPA-1, and RPA-2 in kidneys of gentamicin-, cisplatin-, and valproic acid-treated rats: potential role of iNOS and nitrotyrosine
    Jun Zhang
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Toxicol Pathol 37:629-43. 2009
    ..These findings suggest that peroxynitrite formation may be involved in the pathogenesis of Gen and Cis nephrotoxicity and that Kim-1, RPA-1, and RPA-2 have the potential to serve as site-specific biomarkers for Gen or Cis AKI...
  10. doi request reprint Development of cardiac safety translational tools for QT prolongation and torsade de pointes
    Luis G Valerio
    Center for Drug Evaluation and Research, Division of Metabolism and Endocrinology Products, Office of New Drugs, U S Food and Drug Administration, Silver Spring, MD 20903, USA
    Expert Opin Drug Metab Toxicol 9:801-15. 2013
    ....
  11. doi request reprint Gold nanoparticle trafficking of typically excluded compounds across the cell membrane in JB6 Cl 41-5a cells causes assay interference
    Athena M Keene
    Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Nanotoxicology 5:469-78. 2011
    ..The results support the growing consensus that appropriate controls and assay validation should occur prior to interpretation of results of assays using NP...
  12. doi request reprint Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review
    Katherine Tyner
    Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
    Methods Mol Biol 697:17-31. 2011
    ..This chapter reflects the current thinking and experience of the authors. However, this is not a policy document and should not be used in lieu of regulations, published FDA guidances, or direct discussions with the agency...
  13. doi request reprint Quantitative determination of thallium binding to ferric hexacyanoferrate: Prussian blue
    Yongsheng Yang
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Division of Product Quality Research, Silver Spring, MD 20993, USA
    Int J Pharm 353:187-94. 2008
    ..These findings can be utilized to evaluate and predict drug product quality under certain manufacturing and dry storage conditions...
  14. doi request reprint In silico modeling to predict drug-induced phospholipidosis
    Sydney S Choi
    Science and Research Staff, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
    Toxicol Appl Pharmacol 269:195-204. 2013
    ..These models are intended to be utilized for regulatory toxicology applied science needs in screening new drugs for DIPL...
  15. pmc Nanoparticles and the immune system
    Banu S Zolnik
    Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Endocrinology 151:458-65. 2010
    ....
  16. doi request reprint Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. II. Transdermal drug delivery systems
    Anna M Wokovich
    Center for Drug Evaluation and Research, Food and Drug Administration, St Louis, Missouri, USA
    J Biomed Mater Res B Appl Biomater 88:61-5. 2009
    ..Differences among TDDSs were greater for SS than for HDPE, using the F statistic for testing for differences among TDDSs means as a measure of heterogeneity, thereby indicating greater discrimination by SS...
  17. doi request reprint Quantitative determination of cesium binding to ferric hexacyanoferrate: Prussian blue
    Patrick J Faustino
    Division of Product Quality Research, Office of Testing and Research, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    J Pharm Biomed Anal 47:114-25. 2008
    ..These physiochemical properties can be utilized as quality attributes to monitor and predict drug product quality under certain manufacturing and storage conditions and may be utilized to enhance the clinical efficacy of PB...
  18. ncbi request reprint Quantitative measurement of cyanide released from Prussian Blue
    Yongsheng Yang
    Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research, Silver Spring, Maryland 20993, USA
    Clin Toxicol (Phila) 45:776-81. 2007
    ..The U.S. Food and Drug Administration investigated the issue of cyanide release prior to drug approval to ensure the drug's benefits exceeded risks...
  19. ncbi request reprint Validation of an in vitro method for the determination of cyanide release from ferric-hexacyanoferrate: Prussian blue
    Yongsheng Yang
    Food and Drug Administration, Center for Drug Evaluation and Research, Division of Product Quality Research, Silver Spring, MD 20993, USA
    J Pharm Biomed Anal 43:1358-63. 2007
    ..05 to 0.5 ppm (mg/L). The R(2) ranged from 0.9925 to 0.9998. This validated method was successfully implemented to determine cyanide release from PB under various pH conditions (from 1.0 to 12) at different time-points (from 1 to 24 h)...
  20. doi request reprint Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs
    Banu S Zolnik
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, 10903 New Hampshire Avenue, WO51, HFD 003, Silver Spring, MD 20993, USA
    Adv Drug Deliv Rev 61:422-7. 2009
    ....