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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. Among authors: burnham jm. 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.
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ, Sun H, Burnham J, Liu XI, van den Anker J, Temeck J, Yao L, McCune SK, Burckart GJ. Green DJ, et al. Clin Pharmacol Ther. 2019 Mar;105(3):555-557. doi: 10.1002/cpt.1117. Epub 2018 Aug 9. Clin Pharmacol Ther. 2019. PMID: 30094815 Free PMC article. Review.
Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
Liu XI, Dallmann A, Wang YM, Green DJ, Burnham JM, Chiang B, Wu P, Sheng M, Lu K, van den Anker JN, Burckart GJ. Liu XI, et al. Among authors: burnham jm. J Clin Pharmacol. 2019 Aug;59(8):1130-1143. doi: 10.1002/jcph.1406. Epub 2019 Mar 13. J Clin Pharmacol. 2019. PMID: 30865317 Free PMC article.
Zinc Optic Neuropathy.
McAnnis KE, Burnham JM, Alogaidi DA, Davila PA, Laylani NA, Lee AG. McAnnis KE, et al. Among authors: burnham jm. J Neuroophthalmol. 2023 Jul 24. doi: 10.1097/WNO.0000000000001939. Online ahead of print. J Neuroophthalmol. 2023. PMID: 37486936 No abstract available.
116 results