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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. 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.
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