Gilbert J Burckart

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Pharmacogenomics: the key to improved drug therapy in transplant patients
    Gilbert J Burckart
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Clin Lab Med 28:411-22, vi. 2008
  2. doi request reprint Update on the clinical pharmacogenomics of organ transplantation
    Gilbert J Burckart
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 3184, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:227-36. 2010
  3. doi request reprint Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007
    Jeremiah D Momper
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
    JAMA Pediatr 167:926-32. 2013
  4. doi request reprint Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors
    Jane P F Bai
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
    Pharmacotherapy 30:195-209. 2010
  5. doi request reprint Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use
    Felix W Frueh
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20993, USA
    Pharmacotherapy 28:992-8. 2008
  6. pmc Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop
    Jane P F Bai
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 13:274-83. 2011
  7. doi request reprint Extrapolation of adult data and other data in pediatric drug-development programs
    Julia Dunne
    Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA
    Pediatrics 128:e1242-9. 2011

Collaborators

Detail Information

Publications7

  1. doi request reprint Pharmacogenomics: the key to improved drug therapy in transplant patients
    Gilbert J Burckart
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Clin Lab Med 28:411-22, vi. 2008
    ..Improvements in transplant outcome using these drugs have stalled, and an understanding of the pharmacogenomics of immunosuppressive dosing and response holds the greatest promise for advancing the use of these agents...
  2. doi request reprint Update on the clinical pharmacogenomics of organ transplantation
    Gilbert J Burckart
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 3184, Silver Spring, MD 20993, USA
    Pharmacogenomics 11:227-36. 2010
    ..In the future, clinical pharmacogenomics will be a routine part of patient care for organ transplant patients...
  3. doi request reprint Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007
    Jeremiah D Momper
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
    JAMA Pediatr 167:926-32. 2013
    ..To our knowledge, no previous assessments regarding the need for an intensive pharmacokinetic study in adolescents have been performed...
  4. doi request reprint Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors
    Jane P F Bai
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
    Pharmacotherapy 30:195-209. 2010
    ..The disease-associated genes provide candidate genes for exploring ADEs and may provide genomic biomarkers for assessing the risk for developing severe calcineurin inhibitor-related ADEs as well as for developing preventive strategies...
  5. doi request reprint Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use
    Felix W Frueh
    Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20993, USA
    Pharmacotherapy 28:992-8. 2008
    ....
  6. pmc Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop
    Jane P F Bai
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    AAPS J 13:274-83. 2011
    ....
  7. doi request reprint Extrapolation of adult data and other data in pediatric drug-development programs
    Julia Dunne
    Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA
    Pediatrics 128:e1242-9. 2011
    ..We examined the experience of the FDA in using extrapolation to evaluate how and when it was used and any changes in scientific assumptions over time...