Nagao L[au] - Search Results

Year	Number of Results
2004	1
2007	3
2008	1
2009	1
2013	1
2014	3
2015	5
2016	2
2018	1
2019	1
2020	2
2021	2
2022	3
2023	2
2024	2

1

Framework for sensitization assessment of extractables and leachables in pharmaceuticals.

Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Graham J, Johann E, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Tien E, Cruz M, Nagao L. Parris P, et al. Among authors: nagao l. Crit Rev Toxicol. 2022 Feb;52(2):125-138. doi: 10.1080/10408444.2022.2065966. Epub 2022 Jun 15. Crit Rev Toxicol. 2022. PMID: 35703156 Review.

2

Spray Pattern and Plume Geometry Testing and Methodology: An IPAC-RS Working Group Overview.

Baxter S, Myatt B, Stein S, Parkinson A, Chambers F, Doub B, Grmas J, Suman J, Miller K, Sinha B, Liao L, Carter I, Farina D, Sarrailh S, Fischer M, Walsh D, Nagao L. Baxter S, et al. Among authors: nagao l. AAPS PharmSciTech. 2022 May 18;23(5):145. doi: 10.1208/s12249-022-02278-w. AAPS PharmSciTech. 2022. PMID: 35585210 Review.

3

An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to Other Dosage Forms.

Khan HS, Despres-Gnis F, Stults CLM, Mullis J, Nugara N, Sen A, Nagao L. Khan HS, et al. Among authors: nagao l. AAPS PharmSciTech. 2023 Jan 18;24(1):37. doi: 10.1208/s12249-022-02491-7. AAPS PharmSciTech. 2023. PMID: 36653673 Review.

4

Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.

Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: nagao l. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.

5

Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products.

Stults CL, Reckzuegel G, Bailey A, Petersen J, Dick L, Feinberg T, Feilden A, Miller S, Connors J, Nagao LM. Stults CL, et al. Among authors: nagao lm. Pharm Res. 2016 Jan;33(1):1-17. doi: 10.1007/s11095-015-1770-7. Epub 2015 Sep 3. Pharm Res. 2016. PMID: 26334501 Review. No abstract available.

6

Collaborations between Clinical Pharmacologists in Japan and in the United States - Report from the IQ CPLG and JPMA CPTF Meeting in Tokyo, Japan.

Zhu T, Kayama M, Girish S, Sinha V, Bello A, Kawaguchi A, Czerniak R, Nagao L. Zhu T, et al. Among authors: nagao l. Clin Transl Sci. 2021 Jan;14(1):102-105. doi: 10.1111/cts.12853. Epub 2020 Sep 24. Clin Transl Sci. 2021. PMID: 32969589 Free PMC article. Review.

7

Foreign particles testing in orally inhaled and nasal drug products.

Blanchard J, Coleman J, Hayling CD, Ghaderi R, Haeberlin B, Hart J, Jensen S, Malcolmson R, Mittelman S, Nagao LM, Sekulic S, Snodgrass-Pilla C, Sundahl M, Thompson G, Wolff R; International Pharmaceutical Aerosol Consortium on Regulation; Science Foreign Particles Working Group. Blanchard J, et al. Among authors: nagao lm. Pharm Res. 2004 Dec;21(12):2137-47. doi: 10.1007/s11095-004-7665-7. Pharm Res. 2004. PMID: 15648243 Review.

8

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

Broschard TH, Glowienke S, Bruen US, Nagao LM, Teasdale A, Stults CL, Li KL, Iciek LA, Erexson G, Martin EA, Ball DJ. Broschard TH, et al. Among authors: nagao lm. Regul Toxicol Pharmacol. 2016 Nov;81:201-211. doi: 10.1016/j.yrtph.2016.08.011. Epub 2016 Aug 26. Regul Toxicol Pharmacol. 2016. PMID: 27569203 Review.

9

Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation.

Ball D, Blanchard J, Jacobson-Kram D, McClellan RO, McGovern T, Norwood DL, Vogel W, Wolff R, Nagao L. Ball D, et al. Among authors: nagao l. Toxicol Sci. 2007 Jun;97(2):226-36. doi: 10.1093/toxsci/kfm058. Epub 2007 Mar 16. Toxicol Sci. 2007. PMID: 17369604 Review.

10

Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis.

Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Chilton ML, Graham J, Johann E, Johnson C, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Cruz MT, Nagao L. Parris P, et al. Among authors: nagao l. PDA J Pharm Sci Technol. 2023 Sep 15:pdajpst.2022.012811. doi: 10.5731/pdajpst.2022.012811. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37714567

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