Seo S - Search Results

1

Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox.

Chan-Tack KM, Harrington PR, Choi SY, Myers L, O'Rear J, Seo S, McMillan D, Ghantous H, Birnkrant D, Sherwat AI. Chan-Tack KM, et al. Among authors: seo s. Lancet Infect Dis. 2019 Jun;19(6):e221-e224. doi: 10.1016/S1473-3099(18)30788-6. Epub 2019 Mar 7. Lancet Infect Dis. 2019. PMID: 30853252 Review.

2

Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects.

Liu J, Jadhav PR, Amur S, Fleischer R, Hammerstrom T, Lewis L, Naeger L, O'Rear J, Pacanowski M, Robertson S, Seo S, Soon G, Birnkrant D. Liu J, et al. Among authors: seo s. Hepatology. 2013 Mar;57(3):897-902. doi: 10.1002/hep.25764. Epub 2012 Dec 28. Hepatology. 2013. PMID: 22487907

3

Why did the FDA approve efavirenz 800 mg when co-administered with rifampin?

Liu J, Chan-Tack KM, Jadhav P, Seo S, Robertson SM, Kraft J, Singer ME, Struble KA, Arya V. Liu J, et al. Among authors: seo s. Int J Clin Pharmacol Ther. 2014 Jun;52(6):446-53. doi: 10.5414/CP202079. Int J Clin Pharmacol Ther. 2014. PMID: 24755134

4

Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

Bergman KL, Krudys K, Seo SK, Florian J. Bergman KL, et al. Among authors: seo sk. J Pharmacokinet Pharmacodyn. 2017 Apr;44(2):153-160. doi: 10.1007/s10928-017-9516-2. Epub 2017 Mar 15. J Pharmacokinet Pharmacodyn. 2017. PMID: 28299529

5

Effects of Sorbitol on the Pharmacokinetics of Lamivudine Solution and the FDA's Decision to Increase the Dose of Lamivudine Solution for Pediatric Patients.

Choi SY, Viswanathan P, Sherwat A, Seo SK. Choi SY, et al. Clin Pharmacol Ther. 2018 Nov;104(5):785-787. doi: 10.1002/cpt.1147. Epub 2018 Aug 6. Clin Pharmacol Ther. 2018. PMID: 30084119

6

Antimicrobial Dose Selection under the Animal Rule.

Wu K, Choi SY, Bergman K, Seo S. Wu K, et al. Among authors: seo s. Clin Pharmacol Ther. 2021 Apr;109(4):971-976. doi: 10.1002/cpt.2201. Epub 2021 Mar 6. Clin Pharmacol Ther. 2021. PMID: 33565088 Review.

7

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.

Mulugeta Y, Barrett JS, Nelson R, Eshete AT, Mushtaq A, Yao L, Glasgow N, Mulberg AE, Gonzalez D, Green D, Florian J, Krudys K, Seo S, Kim I, Chilukuri D, Burckart GJ. Mulugeta Y, et al. Among authors: seo s. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.

8

Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective.

Bi Y, Liu J, Wang J, Epps RE, Kettl D, Marcus K, Seo S, Zhu H, Wang Y. Bi Y, et al. Among authors: seo s. AAPS J. 2019 Jul 19;21(5):91. doi: 10.1208/s12248-019-0363-5. AAPS J. 2019. PMID: 31325056

9

A Survey of Neonatal Pharmacokinetic and Pharmacodynamic Studies in Pediatric Drug Development.

Wang J, Avant D, Green D, Seo S, Fisher J, Mulberg AE, McCune SK, Burckart GJ. Wang J, et al. Among authors: seo s. Clin Pharmacol Ther. 2015 Sep;98(3):328-35. doi: 10.1002/cpt.149. Clin Pharmacol Ther. 2015. PMID: 25975723 Review.

10

Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs.

Momper JD, Chang Y, Jackson M, Schuette P, Seo S, Younis I, Abernethy DR, Yao L, Capparelli EV, Burckart GJ. Momper JD, et al. Among authors: seo s. Ther Innov Regul Sci. 2015 Mar;49(2):302-309. doi: 10.1177/2168479014565471. Ther Innov Regul Sci. 2015. PMID: 30222418

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