Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
作者信息
Davis Jonathan M, Baer Gerri R, McCune Susan, Klein Agnes, Sato Junko, Fabbri Laura, Mangili Alexandra, Short Mary A, Tansey Susan, Mangum Barry, Hokuto Isamu, Nakamura Hidefumi, Salaets Thomas, Allegaert Karel, Yao Lynne, Blum Michael, Toerner Joseph, Turner Mark, Portman Ron
机构信息
The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA.
US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
出版信息
J Pediatr. 2020 Apr;219:243-249.e1. doi: 10.1016/j.jpeds.2019.09.060. Epub 2019 Nov 8.
Abstract
摘要
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Vaccine. 2023 Aug 31;41(38):5622-5629. doi: 10.1016/j.vaccine.2023.07.072. Epub 2023 Aug 1.
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Assessment of long-term neurodevelopmental outcome following trials of medicinal products in newborn infants.评估新生儿药物试验的长期神经发育结局。
Pediatr Res. 2019 Nov;86(5):567-572. doi: 10.1038/s41390-019-0526-1. Epub 2019 Aug 9.
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Use of off-label and unlicensed medicines in neonatal intensive care.新生儿重症监护中使用标签外用药和未注册药物。
PLoS One. 2018 Sep 25;13(9):e0204427. doi: 10.1371/journal.pone.0204427. eCollection 2018.
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Unlicensed and Off-Label Medication Use in Pediatric and Neonatal Intensive Care Units: No Change Over a Decade.儿科和新生儿重症监护病房未授权和标签外用药的使用：十年来没有变化。
Adv Ther. 2018 Jul;35(7):1122-1132. doi: 10.1007/s12325-018-0732-y. Epub 2018 Jun 15.
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