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Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.

Tyner K, Sadrieh N. Tyner K, et al. Among authors: sadrieh n. Methods Mol Biol. 2011;697:17-31. doi: 10.1007/978-1-60327-198-1_3. Methods Mol Biol. 2011. PMID: 21116951

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Skin sensitization testing needs and data uses by US regulatory and research agencies.

Strickland J, Daniel AB, Allen D, Aguila C, Ahir S, Bancos S, Craig E, Germolec D, Ghosh C, Hudson NL, Jacobs A, Lehmann DM, Matheson J, Reinke EN, Sadrieh N, Vukmanovic S, Kleinstreuer N. Strickland J, et al. Among authors: sadrieh n. Arch Toxicol. 2019 Feb;93(2):273-291. doi: 10.1007/s00204-018-2341-6. Epub 2018 Oct 30. Arch Toxicol. 2019. PMID: 30377734 Free PMC article. Review.

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CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products.

Cruz CN, Tyner KM, Velazquez L, Hyams KC, Jacobs A, Shaw AB, Jiang W, Lionberger R, Hinderling P, Kong Y, Brown PC, Ghosh T, Strasinger C, Suarez-Sharp S, Henry D, Van Uitert M, Sadrieh N, Morefield E. Cruz CN, et al. Among authors: sadrieh n. AAPS J. 2013 Jul;15(3):623-8. doi: 10.1208/s12248-013-9466-6. Epub 2013 Mar 20. AAPS J. 2013. PMID: 23512727 Free PMC article.

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Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs.

Zolnik BS, Sadrieh N. Zolnik BS, et al. Among authors: sadrieh n. Adv Drug Deliv Rev. 2009 Jun 21;61(6):422-7. doi: 10.1016/j.addr.2009.03.006. Epub 2009 Apr 20. Adv Drug Deliv Rev. 2009. PMID: 19389437 Review.

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Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles.

Sadrieh N, Wokovich AM, Gopee NV, Zheng J, Haines D, Parmiter D, Siitonen PH, Cozart CR, Patri AK, McNeil SE, Howard PC, Doub WH, Buhse LF. Sadrieh N, et al. Toxicol Sci. 2010 May;115(1):156-66. doi: 10.1093/toxsci/kfq041. Epub 2010 Feb 15. Toxicol Sci. 2010. PMID: 20156837 Free PMC article.

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Ethinyl estradiol and other human pharmaceutical estrogens in the aquatic environment: a review of recent risk assessment data.

Laurenson JP, Bloom RA, Page S, Sadrieh N. Laurenson JP, et al. Among authors: sadrieh n. AAPS J. 2014 Mar;16(2):299-310. doi: 10.1208/s12248-014-9561-3. Epub 2014 Jan 28. AAPS J. 2014. PMID: 24470211 Free PMC article. Review.

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In silico modeling to predict drug-induced phospholipidosis.

Choi SS, Kim JS, Valerio LG Jr, Sadrieh N. Choi SS, et al. Among authors: sadrieh n. Toxicol Appl Pharmacol. 2013 Jun 1;269(2):195-204. doi: 10.1016/j.taap.2013.03.010. Epub 2013 Mar 27. Toxicol Appl Pharmacol. 2013. PMID: 23541745

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Nanotechnology and therapeutic delivery: a drug regulation perspective.

Sadrieh N, Tyner KM. Sadrieh N, et al. Ther Deliv. 2010 Jul;1(1):83-9. doi: 10.4155/tde.10.6. Ther Deliv. 2010. PMID: 22816122

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Particle size determination of sunscreens formulated with various forms of titanium dioxide.

Wokovich A, Tyner K, Doub W, Sadrieh N, Buhse LF. Wokovich A, et al. Among authors: sadrieh n. Drug Dev Ind Pharm. 2009 Oct;35(10):1180-9. doi: 10.1080/03639040902838043. Drug Dev Ind Pharm. 2009. PMID: 19555241

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Nanoparticles and the immune system.

Zolnik BS, González-Fernández A, Sadrieh N, Dobrovolskaia MA. Zolnik BS, et al. Among authors: sadrieh n. Endocrinology. 2010 Feb;151(2):458-65. doi: 10.1210/en.2009-1082. Epub 2009 Dec 16. Endocrinology. 2010. PMID: 20016026 Free PMC article. Review.

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