Tyner KM - Search Results

1

The evolving landscape of drug products containing nanomaterials in the United States.

D'Mello SR, Cruz CN, Chen ML, Kapoor M, Lee SL, Tyner KM. D'Mello SR, et al. Among authors: tyner km. Nat Nanotechnol. 2017 Jul;12(6):523-529. doi: 10.1038/nnano.2017.67. Epub 2017 Apr 24. Nat Nanotechnol. 2017. PMID: 28436961 Review.

2

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: tyner km. 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.

3

Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

Kapoor M, Lee SL, Tyner KM. Kapoor M, et al. Among authors: tyner km. AAPS J. 2017 May;19(3):632-641. doi: 10.1208/s12248-017-0049-9. Epub 2017 Feb 3. AAPS J. 2017. PMID: 28160164 Review.

4

Development Considerations for Nanocrystal Drug Products.

Chen ML, John M, Lee SL, Tyner KM. Chen ML, et al. Among authors: tyner km. AAPS J. 2017 May;19(3):642-651. doi: 10.1208/s12248-017-0064-x. Epub 2017 Mar 9. AAPS J. 2017. PMID: 28281194 Review.

5

Product quality for nanomaterials: current U.S. experience and perspective.

Tyner KM, Zou P, Yang X, Zhang H, Cruz CN, Lee SL. Tyner KM, et al. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2015 Sep-Oct;7(5):640-54. doi: 10.1002/wnan.1338. Epub 2015 Jan 30. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2015. PMID: 25641690 Review.

6

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

Tyner KM, Zheng N, Choi S, Xu X, Zou P, Jiang W, Guo C, Cruz CN. Tyner KM, et al. AAPS J. 2017 Jul;19(4):1071-1083. doi: 10.1208/s12248-017-0084-6. Epub 2017 Apr 18. AAPS J. 2017. PMID: 28421428 Review.

7

Physiologically Based Pharmacokinetic (PBPK) Modeling of Pharmaceutical Nanoparticles.

Li M, Zou P, Tyner K, Lee S. Li M, et al. AAPS J. 2017 Jan;19(1):26-42. doi: 10.1208/s12248-016-0010-3. Epub 2016 Nov 10. AAPS J. 2017. PMID: 27834047 Review.

8

Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products.

Zou P, Tyner K, Raw A, Lee S. Zou P, et al. AAPS J. 2017 Sep;19(5):1359-1376. doi: 10.1208/s12248-017-0126-0. Epub 2017 Jul 31. AAPS J. 2017. PMID: 28762128 Review.

9

Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future.

Arden NS, Fisher AC, Tyner K, Yu LX, Lee SL, Kopcha M. Arden NS, et al. Int J Pharm. 2021 Jun 1;602:120554. doi: 10.1016/j.ijpharm.2021.120554. Epub 2021 Mar 29. Int J Pharm. 2021. PMID: 33794326 Free article. Review.

10

Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

Bartlett JA, Brewster M, Brown P, Cabral-Lilly D, Cruz CN, David R, Eickhoff WM, Haubenreisser S, Jacobs A, Malinoski F, Morefield E, Nalubola R, Prud'homme RK, Sadrieh N, Sayes CM, Shahbazian H, Subbarao N, Tamarkin L, Tyner K, Uppoor R, Whittaker-Caulk M, Zamboni W. Bartlett JA, et al. AAPS J. 2015 Jan;17(1):44-64. doi: 10.1208/s12248-014-9701-9. Epub 2014 Nov 25. AAPS J. 2015. PMID: 25421459 Free PMC article.

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