S-M Huang

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Drug interaction studies: study design, data analysis, and implications for dosing and labeling
    S M Huang
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 81:298-304. 2007
  2. doi request reprint The utility of modeling and simulation in drug development and regulatory review
    Shiew Mei Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    J Pharm Sci 102:2912-23. 2013
  3. doi request reprint Is this the dose for you?: the role of modeling
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 93:159-62. 2013
  4. doi request reprint The role of physiologically based pharmacokinetic modeling in regulatory review
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:542-9. 2012
  5. doi request reprint Therapeutic protein-drug interactions and implications for drug development
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 87:497-503. 2010
  6. doi request reprint When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 86:475-9. 2009
  7. ncbi request reprint A regulatory viewpoint on transporter-based drug interactions
    L Zhang
    Offices of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Xenobiotica 38:709-24. 2008
  8. doi request reprint The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies
    S U Yasuda
    Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:417-23. 2008
  9. doi request reprint Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice
    S M Huang
    Clin Pharmacol Ther 84:287-94. 2008
  10. ncbi request reprint Medical product development and regulatory science for the 21st century: the critical path vision and its impact on health care
    S Buckman
    Clin Pharmacol Ther 81:141-4. 2007

Detail Information

Publications12

  1. ncbi request reprint Drug interaction studies: study design, data analysis, and implications for dosing and labeling
    S M Huang
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 81:298-304. 2007
    ..In the past 10 years, clinical pharmacology guidances covering important areas have been issued, including pharmacokinetic data in patients with renal and hepatic impairment, dose-response studies, and drug-drug interactions...
  2. doi request reprint The utility of modeling and simulation in drug development and regulatory review
    Shiew Mei Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    J Pharm Sci 102:2912-23. 2013
    ..Published 2013. This article is a U.S. Government work and is in the public domain in the USA. 102:2912-2923, 2013. ..
  3. doi request reprint Is this the dose for you?: the role of modeling
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 93:159-62. 2013
    ..g., age, race, genetics, organ functions, concomitant medications)...
  4. doi request reprint The role of physiologically based pharmacokinetic modeling in regulatory review
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:542-9. 2012
    ..Physiologically based pharmacokinetic (PBPK) modeling and simulation is one of the tools that can be used to address these critical questions...
  5. doi request reprint Therapeutic protein-drug interactions and implications for drug development
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 87:497-503. 2010
    ..The draft guidance updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme- and transporter-based drug interactions during drug development...
  6. doi request reprint When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective
    S M Huang
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 86:475-9. 2009
    ....
  7. ncbi request reprint A regulatory viewpoint on transporter-based drug interactions
    L Zhang
    Offices of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
    Xenobiotica 38:709-24. 2008
    ..In addition, it includes a review case that describes the evaluation of data suggesting a P-gp-based induction interaction...
  8. doi request reprint The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies
    S U Yasuda
    Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 84:417-23. 2008
    ..fda.gov/cder/Offices/OCPB/workshops.htm)...
  9. doi request reprint Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice
    S M Huang
    Clin Pharmacol Ther 84:287-94. 2008
  10. ncbi request reprint Medical product development and regulatory science for the 21st century: the critical path vision and its impact on health care
    S Buckman
    Clin Pharmacol Ther 81:141-4. 2007
  11. ncbi request reprint The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop
    L M Hinman
    Hoffmann La Roche Inc, Nutley, NJ 07110 1199, USA
    Pharmacogenomics J 6:375-80. 2006
    ..2004N-0279. This paper includes a summary of the key features of the draft concept paper, the discussion in Track 2 of the April, 2005 meeting and highlights of the industry comments submitted to the FDA docket following the meeting...
  12. ncbi request reprint The need for education in pharmacogenomics: a regulatory perspective
    F W Frueh
    Pharmacogenomics J 5:218-20. 2005