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Drug Development and Drug
Interactions: Publications
2008
- Huang S-M, Temple R. Is this the drug or dose for you? – impact of ethnic factors in global drug development, regulatory review and clinical practice. Clin Pharmacol Ther. 2008; Sept; 84 (3): 287-294. To read more articles on pharmacoethnicity from the September 2008 issue of Clinical Pharmacology & Therapeutics, visit http://www.nature.com/clpt/journal/v84/n3/index.html or http://www.nature.com/clpt
- Huang, S-M, Strong J, Zhang L, Reynolds, K, Nallani S, Temple R, Abraham S, Al-Habet S, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Rahman NA, Sobel S, Stifano T, Thummel K, Wei X, Yasuda S, Zheng JH, Zhao H, Lesko LJ. New Era in Drug Interaction Evaluation: US FDA Update on CYP Enzymes, Transporters and the Guidance Process, J Clin Pharmacol. 2008 Jun;48(6):662-70. Epub 2008 Mar 31. Available from: http://jcp.sagepub.com/cgi/content/abstract/48/6/662
- Zhang L, Zhang YD, Strong JM, Reynolds KS, Huang S-M. A regulatory view point on transporters, a special edition on “Structure, Function and Regulation of Transporters“, Xenobiotica. 2008 Jul;38 (7):709-24. Available from: http://www.informaworld.com/smpp/content~content=a795430934~db=all~order=page
- Amur S, Frueh F, Lesko LJ, Huang, S-M. Integration and Use of Biomarkers in Drug Development, Regulation and Clinical Practice - A U.S. Regulatory Perspective Biomarkers in Clinical Pharmacology Review, Biomarkers in Medicine. June 2008, Vol. 2, No. 3, Pages 305-311 (doi:10.2217/17520363.2.3.305)
- Yasuda S, Zhang L, Huang S-M. The Role of Ethnicity in Variability in Response to Drugs- focusing on clinical pharmacology studies, Clin Pharmacol Ther; 2008, Sept; 84 (3): 417-423;
Epub: Jul 9; 18615002. Available from: http://www.nature.com/clpt/journal/v84/n3/abs/clpt2008141a.html
2007
- Buckman, S, Huang, S-M, Murphy, S. Medical Product Development and Regulatory Science for the 21st Century: The Critical Path Vision and Its Impact on Health Care, Clin Pharmacol Ther 2007; Feb; 81(2): 141-144. Available from: http://www.nature.com/clpt/journal/v81/n2/abs/6100085a.html
- Huang S-M, Temple R, Throckmorton DC, Lesko L. Drug -drug interactions: study design, data analysis and implications for dosing recommendations, Clin Pharmacol Ther 2007; Feb; 81(2): 298-304. To read more articles on the FDA Critical Path Initiative from the February 2007 issue of Clinical Pharmacology & Therapeutics, visit http://www.nature.com/clpt/journal/v81/n2/index.html or http://www.nature.com/clpt.
2006
- Lei Zhang, John M. Strong, Wei Qiu, Lawrence J. Lesko, and Shiew-Mei Huang. Scientific Perspectives on Drug Transporters and Their Role in Drug Interactions [PDF] [external link] Mol Pharm. 2006; 3(1), 62-69, Epub
Jan 4 2006.
2005
- Andersson, T, Flockhart, DA, Goldstein, DB, Huang, S-M, Kroetz, D, Milos, P, Ratain, M, Thummel, K. Drug metabolizing enzymes- clinical utility of pharmacogenomic test.
Clin Pharmacol Ther. 2005 Dec;78(6):559-81.
[PDF]
- Paine, MF, Ludington, SS, Chen, ML, Stewart, PW, Huang, S-M, Watkins, PB.
Does sex influence proximal small intestinal or p-gp expression? Drug Metab Dispos. 2005 Mar;33(3):426-33. Epub 2004 Dec 17.
2004
- Meadows, M. Preventing serious drug interactions
[HTML] FDA Consumer, July-August 2004
- Huang, S-M, Hall, SD, Watkins, P, Love, LA, Serabjit-Singh, C, Betz, JM,
Hoffman, FA, Honig, P, Coates, PM, Bull, J, Chen, ST, Kearns, GL, Murray, MD. Drug interactions with herbal products & grapefruit
juice: a conference report.
Clin Pharmacol Ther. 2004, 75:1-12.
- Huang S-M, Lesko, LJ. Drug-drug, drug-dietary supplement, and drug-citrus fruit
and other food interactions — what have we learned? J Clin Pharmacol. 2004; 44:559-569.
[PDF]
- Gorski JC, Huang S-M, Pinto A, Hamman MA, Hilligoss JK, Zaheer NA, Desai M,
Miller M, Hall, SD. The effect of echinacea on cytochrome p450 activity in vivo. Clin Pharmacol Ther. 2004 Jan;75(1):89-100.
2003
- Advisory Committee for Pharmaceutical Science Clinical Pharmacology Section meeting minutes. April 20-21, 2003 (CYP3A classification and P-gp), Nov 17-18, 2003 (CYP2B6 and CYP2C8) [HTML], November 3, 2004 (Drug interaction concept paper)
[PDF]
- Hall SD, Wang Z, Huang, S-M, Hamman MA, Vasavada N, Adigun AQ,
Hilligoss J, Miller M, Gorski, JC. The interaction between St John’s wort and an oral contraceptive. Clin Pharmacol Ther. 2003 Dec;74(6):525-35.
2002
- Yuan R, Madani S, Wei X, Reynolds K, and Huang S-M. Evaluation of P450 probe substrates commonly used by the pharmaceutical industry to study in vitro drug interactions.” Drug Metab Dispos. 2002, Dec;30(12):1311-9. [PDF]
- Wang Z, Hamman MA, Huang S-M, Lesko, LJ, Hall SD. Effect of St John's wort on the pharmacokinetics of fexofenadine. Clin Pharmacol Ther. 2002 Jun;71(6):414-20.
2001
- Tucker G, Houston JB, and Huang S-M. Optimizing drug development: strategies to assess drug
metabolism/transporter interaction potential — toward a consensus. Clin Pharmacol Ther. 2001 Aug;70(2):103-14; Br J Clin Pharmacol. 2001 Jul;52(1):107-17; Eur J Pharm Sci. 2001 Jul;13(4):417-28; Pharm Res. 2001, Aug;18(8):1071-80.
- Wang Z, Gorski JC, Brater C, Huang S-M, Lesko, LJ, and Hall SD. The effects of St. John’s wort on human cytochrome P450 activity. Clin Pharmacol Ther. 2001 Oct;70(4):317-26.
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Date created: May 1, 2006; Updated: October 2, 2008 |
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