用于儿科临床药理学的个体发生知识基础的科学和监管考虑因素。
Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology.
机构信息
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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.
出版信息
Clin Pharmacol Ther. 2020 Apr;107(4):707-709. doi: 10.1002/cpt.1763. Epub 2020 Jan 26.
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.
摘要
了解从胎儿到青春期儿童的药物治疗受影响的发育生物学或儿科个体发生的所有方面，是儿科科学家和临床药理学家的圣杯。科学界现在已经接近于能够将过去 60 年来收集的大量关于儿科个体发生的信息联系在一起。一个有组织的知识库和新工具将使我们能够在儿科药物开发中有效地利用这些信息。
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