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Novel bioequivalence approach for narrow therapeutic index drugs.
Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762
Advancing Product Quality: a Summary of the Second FDA/PQRI Conference.
Yu LX, Akseli I, Allen B, Amidon G, Bizjak TG, Boam A, Caulk M, Doleski D, Famulare J, Fisher AC, Furness S, Hasselbalch B, Havel H, Hoag SW, Iser R, Johnson BD, Ju R, Katz P, Lacana E, Lee SL, Lostritto R, McNally G, Mehta M, Mohan G, Nasr M, Nosal R, Oates M, O'Connor T, Polli J, Raju GK, Ramanadham M, Randazzo G, Rosencrance S, Schwendeman A, Selen A, Seo P, Shah V, Sood R, Thien MP, Tong T, Trout BL, Tyner K, Vaithiyalingam S, VanTrieste M, Walsh F, Wesdyk R, Woodcock J, Wu G, Wu L, Yu L, Zezza D. Yu LX, et al. Among authors: yu l. AAPS J. 2016 Mar;18(2):528-43. doi: 10.1208/s12248-016-9874-5. Epub 2016 Feb 9. AAPS J. 2016. PMID: 26860627 Free PMC article. No abstract available.
368 results