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Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations

机译:赋形剂在非标签儿科配方中的安全和生物制药挑战

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摘要

One of the major challenges in pediatric treatment is the lack of suitable drug preparations specifically designed and marketed for children. Most of the FDA approved drug formulations for adults have not been approved for use in pediatric patients. Shortage of suitable pediatric dosage information often leads health professionals to use adult formulations in an off-label manner. The aim of this work was to review the safety and biopharmaceutical challenges of commonly found excipients in off-label pediatric formulations as well as to show the current progress to alleviate pediatric toxicity related to excipients.
机译:儿科治疗的主要挑战之一是缺乏专门为儿童设计和销售的合适药品制剂。大多数FDA批准的成人药物配方尚未批准用于儿科患者。合适的儿科剂量信息缺乏往往导致健康专业人士以非标签方式使用成人配方。这项工作的目的是审查常用的儿科制剂中常见赋形剂的安全和生物制药挑战,以及展示当前的进展,以减轻与赋形剂相关的儿科毒性。

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