Nagao L - Search Results

1

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.

2

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.

3

European Regulatory Developments for Orally Inhaled and Nasal Drug Products.

Santos C, Marco G, Nagao LM, Castro E, Chesworth T. Santos C, et al. AAPS PharmSciTech. 2018 Oct;19(7):3134-3140. doi: 10.1208/s12249-018-1154-5. Epub 2018 Aug 20. AAPS PharmSciTech. 2018. PMID: 30128799

4

Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and Other Drug--Device Combination Products.

Stults CLM, Lanning CL, Nagao LM, Conners J. Stults CLM, et al. Among authors: nagao lm. PDA J Pharm Sci Technol. 2024 Feb 20;78(1):125-139. doi: 10.5731/pdajpst.2023.012852. PDA J Pharm Sci Technol. 2024. PMID: 37973193

5

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.

6

Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study.

Teasdale A, Jahn M, Bailey S, Feilden A, Taylor G, Corcoran ML, Malick R, Jenke D, Stults CL, Nagao LM. Teasdale A, et al. Among authors: nagao lm. AAPS PharmSciTech. 2015 Jun;16(3):664-74. doi: 10.1208/s12249-014-0249-x. Epub 2014 Dec 16. AAPS PharmSciTech. 2015. PMID: 25511807 Free PMC article.

7

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.

8

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products.

Silva MC, Costa HS, Valadares BN, Grecchi L, Nagao L, Santos GML. Silva MC, et al. Among authors: nagao l. AAPS PharmSciTech. 2019 Jun 24;20(6):235. doi: 10.1208/s12249-019-1415-y. AAPS PharmSciTech. 2019. PMID: 31236849

9

Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.

Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Among authors: nagao lm. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429

10

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.

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