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New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.
Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ. Huang SM, et al. Among authors: burckart gj. J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. J Clin Pharmacol. 2008. PMID: 18378963 Review.
Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications.
Zhang Y, Zhang L, Abraham S, Apparaju S, Wu TC, Strong JM, Xiao S, Atkinson AJ Jr, Thummel KE, Leeder JS, Lee C, Burckart GJ, Lesko LJ, Huang SM. Zhang Y, et al. Among authors: burckart gj. Clin Pharmacol Ther. 2009 Mar;85(3):305-11. doi: 10.1038/clpt.2008.208. Epub 2008 Nov 19. Clin Pharmacol Ther. 2009. PMID: 19020495
Pediatric dose selection.
Abernethy DR, Burckart GJ. Abernethy DR, et al. Among authors: burckart gj. Clin Pharmacol Ther. 2010 Mar;87(3):270-1. doi: 10.1038/clpt.2009.292. Clin Pharmacol Ther. 2010. PMID: 20160747 Review.
Biomarkers in solid organ transplantation.
Gieser G, Harigaya H, Colangelo PM, Burckart G. Gieser G, et al. Clin Pharmacol Ther. 2011 Aug;90(2):217-20. doi: 10.1038/clpt.2011.75. Clin Pharmacol Ther. 2011. PMID: 21772300
Clinical pharmacology as a cornerstone of orphan drug development.
Bashaw ED, Huang SM, Coté TR, Pariser AR, Garnett CE, Burckart G, Zhang L, Men AY, Le CD, Charlab R, Gobburu JV, Lesko LJ. Bashaw ED, et al. Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595. Nat Rev Drug Discov. 2011. PMID: 22037026
285 results