Steven Hirschfeld

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. pmc HIV-1 infected monozygotic twins: a tale of two outcomes
    Loubna Tazi
    Division of Epidemiology, Human Genetics and Environmental Sciences, University of Texas, Health Science Center at Houston, School of Public Health, Brownsville, TX, USA
    BMC Evol Biol 11:62. 2011
  2. doi request reprint Pediatric regulatory initiatives
    Steven Hirschfeld
    National Children s Study Eunice Kennedy Shriver, National Institute of Child Health and Human Development, Bethesda, MD 20892, USA
    Handb Exp Pharmacol 205:245-68. 2011
  3. pmc National Children's Study: update in 2010
    Steven Hirschfeld
    Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA
    Mt Sinai J Med 78:119-25. 2011
  4. ncbi request reprint FDA drug approval summaries: oxaliplatin
    Amna Ibrahim
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 9:8-12. 2004
  5. ncbi request reprint The role of the fDA in cancer clinical trials
    Steven Hirschfeld
    Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Response, Food and Drug Administration Rockville, MD, USA
    Cancer Treat Res 132:51-109. 2007
  6. pmc Guiding the optimal translation of new cancer treatments from canine to human cancer patients
    Chand Khanna
    School of Veterinary Medicine, University of Wisconsin Madison, Madison, Wisconsin, USA
    Clin Cancer Res 15:5671-7. 2009
  7. ncbi request reprint Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report
    Steven Z Pavletic
    National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 1203, USA
    Biol Blood Marrow Transplant 12:252-66. 2006
  8. pmc New models for large prospective studies: is there a better way?
    Teri A Manolio
    Office of Population Genomics, National Human Genome Research Institute, Bethesda, Maryland, USA
    Am J Epidemiol 175:859-66. 2012
  9. ncbi request reprint Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives
    Steven Hirschfeld
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    J Clin Oncol 21:1066-73. 2003
  10. ncbi request reprint The pediatric research equity act and oncology
    Steven Hirschfeld
    Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 755, Rockville, MD 20852, USA
    Pediatr Blood Cancer 43:99-102. 2004

Detail Information

Publications10

  1. pmc HIV-1 infected monozygotic twins: a tale of two outcomes
    Loubna Tazi
    Division of Epidemiology, Human Genetics and Environmental Sciences, University of Texas, Health Science Center at Houston, School of Public Health, Brownsville, TX, USA
    BMC Evol Biol 11:62. 2011
    ..We explore the evolutionary processes and population dynamics that shape viral diversity of HIV in these monozygotic twins...
  2. doi request reprint Pediatric regulatory initiatives
    Steven Hirschfeld
    National Children s Study Eunice Kennedy Shriver, National Institute of Child Health and Human Development, Bethesda, MD 20892, USA
    Handb Exp Pharmacol 205:245-68. 2011
    ....
  3. pmc National Children's Study: update in 2010
    Steven Hirschfeld
    Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA
    Mt Sinai J Med 78:119-25. 2011
    ..Three different recruitment strategies are under evaluation to determine what approach to use for the Main Study. The organization of National Children's Study operations is currently based on a new decentralized business model...
  4. ncbi request reprint FDA drug approval summaries: oxaliplatin
    Amna Ibrahim
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 9:8-12. 2004
    ..Approval was based on response rate and on an interim analysis of TTP. No results are available, at this time, that demonstrate a clinical benefit, such as improvement in disease-related symptoms or survival...
  5. ncbi request reprint The role of the fDA in cancer clinical trials
    Steven Hirschfeld
    Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Response, Food and Drug Administration Rockville, MD, USA
    Cancer Treat Res 132:51-109. 2007
  6. pmc Guiding the optimal translation of new cancer treatments from canine to human cancer patients
    Chand Khanna
    School of Veterinary Medicine, University of Wisconsin Madison, Madison, Wisconsin, USA
    Clin Cancer Res 15:5671-7. 2009
    ..A summary of this meeting and subsequent discussion are provided here to afford clarity on the conduct of these studies so as to optimize the opportunities provided by this novel drug development and modeling strategy...
  7. ncbi request reprint Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report
    Steven Z Pavletic
    National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 1203, USA
    Biol Blood Marrow Transplant 12:252-66. 2006
    ..The proposed response criteria are based on current expert consensus opinion and are intended to improve consistency in the conduct and reporting of chronic GVHD trials, but their use remains to be demonstrated in practice...
  8. pmc New models for large prospective studies: is there a better way?
    Teri A Manolio
    Office of Population Genomics, National Human Genome Research Institute, Bethesda, Maryland, USA
    Am J Epidemiol 175:859-66. 2012
    ..Whether and how these approaches may be transportable to the United States remain to be explored, but their success in studies such as UK Biobank makes a compelling case for such explorations to begin...
  9. ncbi request reprint Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives
    Steven Hirschfeld
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    J Clin Oncol 21:1066-73. 2003
    ..To review the Food and Drug Administration (FDA) experience with approvals of new drugs for pediatric oncology and to discuss new regulatory initiatives directed at pediatric oncology...
  10. ncbi request reprint The pediatric research equity act and oncology
    Steven Hirschfeld
    Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 755, Rockville, MD 20852, USA
    Pediatr Blood Cancer 43:99-102. 2004