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U.S. Department of Health and Human Services

Drugs

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Drug Development and Drug Interactions: Publications


2012

  • Morrissey KM, Wen CC, Johns SJ, Zhang L, Huang SM, Giacomini KM. Commentaries: The UCSF-FDA TransPortal: A Public Drug Transporter Database. Clin Pharmacol Ther. 2012 Nov,92 (5):545-6. doi: 10.1038/clpt.2012.44.
    http://www.ncbi.nlm.nih.gov/pubmed?term=morrissey%20km%2C%20the%20ucsf-fda%20transportal 
  • Zhao P, Rowland M, and Huang S-M, Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther, 2012, Jul;92(1):17-20. doi: 10.1038/clpt.2012.68.
    http://www.ncbi.nlm.nih.gov/pubmed?term=22713733
  • Leong R, Vieira ML, Zhao P, Mulugeta Y, Lee CS, Huang SM, and Burckart GJ. Regulatory Experience with Physiologically-Based Pharmacokinetic Modeling for Pediatric Drug Trials, Clin Pharmacol Ther, 2012, May;91(5):926-31. http://www.ncbi.nlm.nih.gov/pubmed?term=22472993
  • Park EJ, Pai MP, Dong T, Zhang J, Ko CW, Lawrence J, Crentsil V, Zhang L, Xu NN. The Influence of Body Size Descriptors on the Estimation of Kidney Function in Normal Weight, Overweight, Obese, and Morbidly Obese Adults.  Ann Pharmacother 2012 Mar;46(3):317-28. Epub 2012 Mar 6. http://www.ncbi.nlm.nih.gov/pubmed/22395245
  • Vieira M, Zhao P, Berglund EG, Reynolds KS, Zhang L, Lesko LJ, Huang SM. Predicting Drug Interaction Potential With a Physiologically Based Pharmacokinetic Model: A Case Study of Telithromycin, a Time-Dependent CYP3A Inhibitor. Clin Pharmacol Ther. 2012 Mar 7. doi: 10.1038/clpt.2011.305. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/22398966
  • Huang SM.  Invited commentary: PBPK as a tool in regulatory review.  Biopharm Drug Dispos. 2012 Feb 20. doi: 10.1002/bdd.1777. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/22351604
  • Huang SM and Rowland M. The role of physiologically based pharmacokinetic modeling in regulatory review. Clin Pharmacol Ther. 2012 Mar;91(3):542-9. doi: 10.1038/clpt.2011.320. Epub 2012 Feb 8.  http://www.ncbi.nlm.nih.gov/pubmed/22318616
  • Agarwal S, Arya V, Zhang L. Review of P-gp Inhibition Data in Recently Approved New Drug Applications: Utility of the Proposed [I1]/IC50 and [I2]/IC50 Criteria in the P-gp Decision Tree. J Clin Pharmacol. 2012 Feb 7. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/22319057
  • 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.  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. Biopharm Drug Dispos. 2012 Jan 23. doi: 10.1002/bdd.1771. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/22270945
  • Zhao P, Vieira Mde L, Grillo JA, Song P, Wu TC, Zheng JH, Arya V, Berglund EG, Atkinson AJ Jr, Sugiyama Y, Pang KS, Reynolds KS, Abernethy DR, Zhang L, Lesko LJ, Huang SM. Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation. J Clin Pharmacol. 2012 Jan;52(1 Suppl):91S-108S.  http://www.ncbi.nlm.nih.gov/pubmed/22232759
  • Zhang L, Xu N, Xiao S, Arya V, Zhao P, Lesko LJ, Huang SM. Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease. J Clin Pharmacol. 2012 Jan;52(1 Suppl):79S-90S. http://www.ncbi.nlm.nih.gov/pubmed/22232757
     

2011

  • Zineh I and Huang SM. Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine.  Biomark Med 2011 Dec;5(6):705-13. http://www.ncbi.nlm.nih.gov/pubmed/22103607 
  • Bashaw ED, Huang SM, Coté TR, Pariser AR, Garnett CE, Burckart G, Zhang L, Men AY, Le CD, Charlab R, Gobburu JV, Lesko LJ. Clinical pharmacology as a cornerstone of orphan drug development. Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595. http://www.ncbi.nlm.nih.gov/pubmed/22037026
  • Zhang L, Huang SM, Lesko LJ.  Transporter-mediated drug-drug interactions. Clin Pharmacol Ther. 2011 Apr;89(4):481-4.  http://www.ncbi.nlm.nih.gov/pubmed/21423238
  • Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM.  Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.  Clin Pharmacol Ther. 2011 Feb;89(2):259-67. Epub 2010 Dec 29. http://www.ncbi.nlm.nih.gov/pubmed/21191381
     

2010

2009

2008

  • Clark P. Avoiding Drug Interactions. FDA Consumer Health Information. 2008 Nov 28.
  • 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 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.