Park K - Search Results

1

Obesity Considerations in Pediatric Drug Development, 2016-2021.

Samuels S, Bhatt-Mehta V, Park K, Burckart GJ. Samuels S, et al. Among authors: park k. J Clin Pharmacol. 2023 Nov;63 Suppl 2:S18-S24. doi: 10.1002/jcph.2305. J Clin Pharmacol. 2023. PMID: 37942908 Review.

2

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.

Tanaudommongkon I, John Miyagi S, Green DJ, Burnham JM, van den Anker JN, Park K, Wu J, McCune SK, Yao L, Burckart GJ. Tanaudommongkon I, et al. Among authors: park k. Clin Pharmacol Ther. 2020 Nov;108(5):1018-1025. doi: 10.1002/cpt.1886. Epub 2020 Jun 22. Clin Pharmacol Ther. 2020. PMID: 32394430 Free PMC article.

3

Dosing Recommendations for Pediatric Patients With Renal Impairment.

Al-Khouja A, Park K, Anderson DJC, Young C, Wang J, Huang SM, Khurana M, Burckart GJ. Al-Khouja A, et al. Among authors: park k. J Clin Pharmacol. 2020 Dec;60(12):1551-1560. doi: 10.1002/jcph.1676. Epub 2020 Jun 15. J Clin Pharmacol. 2020. PMID: 32542790 Free PMC article.

4

Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives.

Momper JD, Green DJ, Park K, Burckart GJ, Snyder DL. Momper JD, et al. Among authors: park k. Ther Innov Regul Sci. 2021 Mar;55(2):282-303. doi: 10.1007/s43441-020-00214-3. Epub 2020 Sep 8. Ther Innov Regul Sci. 2021. PMID: 32901443

5

Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.

Park K, Virparia R, Green DJ, Epps C, Wharton GT, McCune SK, Burckart GJ. Park K, et al. Clin Pharmacol Ther. 2021 Oct;110(4):997-1003. doi: 10.1002/cpt.2306. Epub 2021 Jun 14. Clin Pharmacol Ther. 2021. PMID: 34028811 Free PMC article.

6

Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012-2020.

Green FG, Park K, Burckart GJ. Green FG, et al. Among authors: park k. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S28-S35. doi: 10.1002/jcph.1853. J Clin Pharmacol. 2021. PMID: 34185898

7

Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration.

Kim C, Park K, McMahon AW, Green FG, Green DJ, Burckart GJ. Kim C, et al. Among authors: park k. J Clin Pharmacol. 2021 Jun;61 Suppl 1:S133-S140. doi: 10.1002/jcph.1864. J Clin Pharmacol. 2021. PMID: 34185899 Review.

8

Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007 and 2020.

Park K, Vishnevetskaya K, Vaidyanathan J, Burckart GJ, Green DJ. Park K, et al. J Clin Pharmacol. 2022 Mar;62(3):397-408. doi: 10.1002/jcph.1973. Epub 2021 Oct 19. J Clin Pharmacol. 2022. PMID: 34562277 Review.

9

Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020.

Park K, Tran NK, Momper JD, Green DJ, Burckart GJ. Park K, et al. J Clin Pharmacol. 2022 Aug;62(8):970-982. doi: 10.1002/jcph.2035. Epub 2022 Mar 11. J Clin Pharmacol. 2022. PMID: 35118684

10

Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.

Samuels S, Park K, Bhatt-Mehta V, Sun H, Mulugeta Y, Yao L, Green DJ, Burckart GJ. Samuels S, et al. Among authors: park k. J Clin Pharmacol. 2023 Mar;63(3):307-313. doi: 10.1002/jcph.2160. Epub 2022 Oct 19. J Clin Pharmacol. 2023. PMID: 36150423 Review.

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