Issam Zineh

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi 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
  2. ncbi 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
  3. ncbi 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
  4. ncbi 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
  5. ncbi 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
  6. ncbi Cyp2d6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the US 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, US Food and Drug Administration, 10903 New Hampshire Ave, White Oak Bldg 51, Room 3175, Silver Spring, MD 20993
    J Clin Psychiatry 73:1187-90. 2012
  7. ncbi 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
  8. ncbi 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
  9. ncbi 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
  10. ncbi 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

Collaborators

Detail Information

Publications11

  1. ncbi 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
    ....
  2. ncbi 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...
  3. ncbi 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
    ....
  4. ncbi 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
    ....
  5. ncbi 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...
  6. ncbi Cyp2d6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the US 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, US Food and Drug Administration, 10903 New Hampshire Ave, White Oak Bldg 51, Room 3175, Silver Spring, MD 20993
    J Clin Psychiatry 73:1187-90. 2012
    ....
  7. ncbi 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...
  8. ncbi 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
    ....
  9. ncbi 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...
  10. ncbi 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
    ....
  11. ncbi 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
    ....