An N Massaro, Elimika Pfuma Fletcher, Rajanikanth Madabushi, Gerri Baer, Dionna Green
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A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.
Drug development in the neonatal population remains an unmet need in health care. While incentives and legislative mandates have had some impact on increasing drug development in pediatric patients, the advancement of neonatal therapeutics faces unique challenges. This review summarizes relevant regulatory history, clinical, pharmacological and ethical considerations that characterize the landscape of drug development in neonates. Research priorities and future directions for advancing safe and effective medicines for the vulnerable neonatal population are discussed.
期刊介绍:
The Journal of Pediatric Pharmacology and Therapeutics is the official journal of the Pediatric Pharmacy Advocacy Group. JPPT is a peer-reviewed multi disciplinary journal that is devoted to promoting the safe and effective use of medications in infants and children. To this end, the journal publishes practical information for all practitioners who provide care to pediatric patients. Each issue includes review articles, original clinical investigations, case reports, editorials, and other information relevant to pediatric medication therapy. The Journal focuses all work on issues related to the practice of pediatric pharmacology and therapeutics. The scope of content includes pharmacotherapy, extemporaneous compounding, dosing, methods of medication administration, medication error prevention, and legislative issues. The Journal will contain original research, review articles, short subjects, case reports, clinical investigations, editorials, and news from such organizations as the Pediatric Pharmacy Advocacy Group, the FDA, the American Academy of Pediatrics, the American Society of Health-System Pharmacists, and so on.