Issam Zineh

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc CXCL5 polymorphisms are associated with variable blood pressure in cardiovascular disease-free adults
    Amber L Beitelshees
    Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD 21201, USA
    Hum Genomics 6:9. 2012
  2. doi request reprint Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation
    I Zineh
    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 93:515-25. 2013
  3. doi request reprint Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview
    Janet Woodcock
    Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 3182, Silver Spring, MD 20993 USA 1 301 796 4756 1 3018478720
    Expert Opin Med Diagn 5:369-74. 2011
  4. pmc Effects of genetic variation in H3K79 methylation regulatory genes on clinical blood pressure and blood pressure response to hydrochlorothiazide
    Julio D Duarte
    Center for Pharmacogenomics and Department of Pharmacotherapy and Translational Research, University of Florida, Gainesville, FL 32610, USA
    J Transl Med 10:56. 2012
  5. doi request reprint Allopurinol pharmacogenetics: assessment of potential clinical usefulness
    Issam Zineh
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD 20993, USA
    Pharmacogenomics 12:1741-9. 2011
  6. doi request reprint Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine
    Issam Zineh
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Biomark Med 5:705-13. 2011
  7. doi request reprint Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration
    Issam Zineh
    Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
    Pharmacotherapy 31:729-35. 2011
  8. doi request reprint Consistency of drug-drug and gene-drug interaction information in US FDA-approved drug labels
    Daniela J Conrado
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, 10903 New Hampshire Avenue, White Oak Building 51, Room 3112, Silver Spring, MD 20993, USA
    Pharmacogenomics 14:215-23. 2013
  9. 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
  10. doi request reprint CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations
    Hobart L Rogers
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Ave, White Oak Bldg 51, Room 3175, Silver Spring, MD 20993, USA
    J Clin Psychiatry 73:1187-90. 2012

Collaborators

Detail Information

Publications17

  1. pmc CXCL5 polymorphisms are associated with variable blood pressure in cardiovascular disease-free adults
    Amber L Beitelshees
    Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD 21201, USA
    Hum Genomics 6:9. 2012
    ..We hypothesized that polymorphisms in the CXCL5 gene, which encodes the neutrophilic chemokine ENA-78, are associated with blood pressure in cardiovascular disease (CVD)-free adults and that these polymorphisms are functional...
  2. doi request reprint Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation
    I Zineh
    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 93:515-25. 2013
    ..Here, we propose that the discipline of clinical pharmacology, in the regulatory setting, is well positioned to build on its past successes in the advancement and acceleration of drug development...
  3. doi request reprint Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview
    Janet Woodcock
    Center for Drug Evaluation and Research, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 3182, Silver Spring, MD 20993 USA 1 301 796 4756 1 3018478720
    Expert Opin Med Diagn 5:369-74. 2011
    ....
  4. pmc Effects of genetic variation in H3K79 methylation regulatory genes on clinical blood pressure and blood pressure response to hydrochlorothiazide
    Julio D Duarte
    Center for Pharmacogenomics and Department of Pharmacotherapy and Translational Research, University of Florida, Gainesville, FL 32610, USA
    J Transl Med 10:56. 2012
    ..This study aimed to determine the role of variation in these regulatory genes on blood pressure response to HCTZ, and secondarily, untreated blood pressure...
  5. doi request reprint Allopurinol pharmacogenetics: assessment of potential clinical usefulness
    Issam Zineh
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD 20993, USA
    Pharmacogenomics 12:1741-9. 2011
    ....
  6. doi request reprint Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine
    Issam Zineh
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Biomark Med 5:705-13. 2011
    ....
  7. doi request reprint Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration
    Issam Zineh
    Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
    Pharmacotherapy 31:729-35. 2011
    ..We hope this perspective provides a window into some ways in which the FDA is enabling individualized therapeutics through its mission-critical activities...
  8. doi request reprint Consistency of drug-drug and gene-drug interaction information in US FDA-approved drug labels
    Daniela J Conrado
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, 10903 New Hampshire Avenue, White Oak Building 51, Room 3112, Silver Spring, MD 20993, USA
    Pharmacogenomics 14:215-23. 2013
    ..To characterize concordance between clinically relevant drug-drug interactions (DDIs) related to CYP2C19, CYP2D6 and CYP2C9 and their analogous gene-drug interactions (GDIs) in US FDA-approved drug labeling...
  9. 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. ..
  10. doi request reprint CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations
    Hobart L Rogers
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Ave, White Oak Bldg 51, Room 3175, Silver Spring, MD 20993, USA
    J Clin Psychiatry 73:1187-90. 2012
    ....
  11. ncbi request reprint Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact
    Federico M Goodsaid
    Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, Maryland 20903 002, USA
    Nat Rev Drug Discov 9:435-45. 2010
    ....
  12. ncbi request reprint Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine
    Kim E Sapsford
    Division of Biology, Office of Science and Engineering Laboratories, CDRH, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Ther Deliv 1:631-41. 2010
    ..These points along with the many regulatory concerns regarding co-labeling of drugs and devices and future aspects, such as co-development, will be discussed in this regulatory science focus...
  13. doi request reprint DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
    Lawrence J Lesko
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, HFD 850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:507-12. 2010
    ....
  14. doi request reprint Pharmacogenetics and coumarin dosing - recalibrating expectations
    Issam Zineh
    From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD
    N Engl J Med 369:2273-5. 2013
    ..Careful assessment of these trials can help to reframe the dialogue regarding evidentiary assessment of coumarin pharmacogenetics. ..
  15. doi request reprint Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant
    Thomas P Laughren
    Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
    J Clin Psychiatry 72:1166-73. 2011
    ....
  16. doi request reprint Continuing to strengthen FDA's science approach to emerging technologies
    Rachael Anatol
    Emerging Technology Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD, USA
    Nanomedicine 9:594-9. 2013
    ..S. Food and Drug Administration plays a critical role in translating innovations into novel safe and effective medical products that improve the public health. ..