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Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.
Grillo JA, Zhao P, Bullock J, Booth BP, Lu M, Robie-Suh K, Berglund EG, Pang KS, Rahman A, Zhang L, Lesko LJ, Huang SM. Grillo JA, et al. Among authors: huang sm. Biopharm Drug Dispos. 2012 Mar;33(2):99-110. doi: 10.1002/bdd.1771. Epub 2012 Mar 4. Biopharm Drug Dispos. 2012. PMID: 22270945
Population pharmacokinetics. A regulatory perspective.
Sun H, Fadiran EO, Jones CD, Lesko L, Huang SM, Higgins K, Hu C, Machado S, Maldonado S, Williams R, Hossain M, Ette EI. Sun H, et al. Among authors: huang sm. Clin Pharmacokinet. 1999 Jul;37(1):41-58. doi: 10.2165/00003088-199937010-00003. Clin Pharmacokinet. 1999. PMID: 10451782 Review.
Bioavailability and bioequivalence: an FDA regulatory overview.
Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R. Chen ML, et al. Among authors: huang sm. Pharm Res. 2001 Dec;18(12):1645-50. doi: 10.1023/a:1013319408893. Pharm Res. 2001. PMID: 11785681 Review.
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.
Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A. Lesko LJ, et al. Among authors: huang sm. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455
1,271 results