Green DJ - Search Results

1

Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.

Noel GJ, Nelson RM, Bucci-Rechtweg C, Portman R, Miller T, Green DJ, Snyder D, Moreno C, Hovinga C, Connor E. Noel GJ, et al. Among authors: green dj. Ther Innov Regul Sci. 2021 Jul;55(4):773-778. doi: 10.1007/s43441-021-00283-y. Epub 2021 Apr 2. Ther Innov Regul Sci. 2021. PMID: 33811302 Free PMC article.

2

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. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.

3

Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development.

McMahon AW, Watt K, Wang J, Green D, Tiwari R, Burckart GJ. McMahon AW, et al. Ther Innov Regul Sci. 2016;2016:1-6. doi: 10.1177/2168479016651661. Epub 2016 Jun 2. Ther Innov Regul Sci. 2016. PMID: 27774353 Free PMC article.

4

Pediatric Drug Development: Outlook for Science-Based Innovation.

Green DJ, Zineh I, Burckart GJ. Green DJ, et al. Clin Pharmacol Ther. 2018 Mar;103(3):376-378. doi: 10.1002/cpt.1001. Epub 2018 Jan 31. Clin Pharmacol Ther. 2018. PMID: 29384202

5

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.

Green DJ, Burnham JM, Schuette P, Liu XI, Maas BM, Yao L, McCune SK, Chen J, van den Anker JN, Burckart GJ. Green DJ, et al. J Clin Pharmacol. 2018 Jul;58(7):885-890. doi: 10.1002/jcph.1109. Epub 2018 Apr 17. J Clin Pharmacol. 2018. PMID: 29663424 Free PMC article.

6

Bone Mineral Density to Assess Pediatric Bone Health in Drug Development.

Maas BM, Wang J, Cooner F, Green D, Yuan Y, Yao L, Burckart GJ. Maas BM, et al. Ther Innov Regul Sci. 2017 Nov;51(6):756-760. doi: 10.1177/2168479017709047. Epub 2017 May 11. Ther Innov Regul Sci. 2017. PMID: 30227097

7

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration.

Liu XI, Schuette P, Burckart GJ, Green DJ, La J, Burnham JM, Rakhmanina N, Robb A, Huang SM, van den Anker JN. Liu XI, et al. Among authors: green dj. J Pediatr. 2019 May;208:236-242.e3. doi: 10.1016/j.jpeds.2018.12.033. Epub 2019 Jan 21. J Pediatr. 2019. PMID: 30679050 Free PMC article.

8

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: green dj. 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.

9

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: green dj. 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

10

Hypothalamic-Pituitary-Adrenal Axis Pediatric Safety Studies Submitted to the FDA.

Burnham JM, Green DJ, Ray A, Fang S, Yao L, McCune SK, Burckart GJ. Burnham JM, et al. Among authors: green dj. Ther Innov Regul Sci. 2021 May;55(3):622-630. doi: 10.1007/s43441-021-00259-y. Epub 2021 Feb 5. Ther Innov Regul Sci. 2021. PMID: 33544387 Review.

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