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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.
Failed Pediatric Drug Development Trials.
Momper JD, Mulugeta Y, Burckart GJ. Momper JD, et al. Among authors: burckart gj. Clin Pharmacol Ther. 2015 Sep;98(3):245-51. doi: 10.1002/cpt.142. Epub 2015 Jun 26. Clin Pharmacol Ther. 2015. PMID: 25963725
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. Among authors: burckart gj. J Clin Pharmacol. 2016 Nov;56(11):1326-1334. doi: 10.1002/jcph.744. J Clin Pharmacol. 2016. PMID: 27040726 Free PMC article. Review.
253 results