S-M Huang

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi 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
  2. ncbi 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
  3. ncbi 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
  4. ncbi 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
  5. ncbi 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
  6. ncbi 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
  7. ncbi 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
  8. ncbi 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
  9. ncbi 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
  10. ncbi 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

Detail Information

Publications11

  1. ncbi 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)...
  2. ncbi 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...
  3. ncbi 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...
  4. ncbi 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...
  5. ncbi 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
    ....
  6. ncbi 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...
  7. ncbi 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)...
  8. ncbi 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
  9. ncbi 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
  10. ncbi 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...
  11. ncbi The need for education in pharmacogenomics: a regulatory perspective
    F W Frueh
    Pharmacogenomics J 5:218-20. 2005