Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.

Journal: Clinical pharmacology and therapeutics
PMID: 31983072

Abstract

Understanding all aspects of developmental biology, or pediatric ontogeny, that affect drug therapy from the fetus to the adolescent child is the holy grail of pediatric scientists and clinical pharmacologists. The scientific community is now close to being able to tie together the vast amount of information collected on pediatric ontogeny over the past 60 years. An organized knowledge base and new tools would allow us to utilize this information effectively in pediatric drug development.

Authors

  • Gilbert J Burckart
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shirley Seo
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Aaron C Pawlyk
    Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.
  • Susan K McCune
    Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Lynne P Yao
    Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • George P Giacoia
    Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.
  • Yaning Wang
    Department of Radiology, The First Hospital of Jilin University, No.1, Xinmin Street, Changchun 130021, China (Y.W., M.L., Z.M., J.W., K.H., Q.Y., L.Z., L.M., H.Z.).
  • Issam Zineh
    Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

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