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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: liu xi. 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. Among authors: liu xi. 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.
Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Liu XI, Momper JD, Rakhmanina NY, Green DJ, Burckart GJ, Cressey TR, Mirochnick M, Best BM, van den Anker JN, Dallmann A. Liu XI, et al. Clin Pharmacokinet. 2021 Jun;60(6):795-809. doi: 10.1007/s40262-020-00977-w. Epub 2021 Feb 2. Clin Pharmacokinet. 2021. PMID: 33527213 Free PMC article.
1,737 results