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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
The value meal: effect of food on lapatinib bioavailability.
Rahman A, Pazdur R, Wang Y, Huang SM, Lesko L. Rahman A, et al. Among authors: huang sm. J Clin Oncol. 2007 Nov 20;25(33):5333-4; author reply 5334-5. doi: 10.1200/JCO.2007.14.6381. J Clin Oncol. 2007. PMID: 18024885 No abstract available.
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. J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. J Clin Pharmacol. 2008. PMID: 18378963 Review.
Predicting drug-drug interactions: an FDA perspective.
Zhang L, Zhang YD, Zhao P, Huang SM. Zhang L, et al. Among authors: huang sm. AAPS J. 2009 Jun;11(2):300-6. doi: 10.1208/s12248-009-9106-3. Epub 2009 May 6. AAPS J. 2009. PMID: 19418230 Free PMC article. Review.
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. Among authors: huang sm. Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595. Nat Rev Drug Discov. 2011. PMID: 22037026
1,239 results