Development of Drug Therapies for Newborns and Children
| Autor: | Vikram Sinha, Lynne Yao, Anne Zajicek, Hari Cheryl Sachs, Yeruk Mulugeta, Susan McCune, Jeffrey S. Barrett |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Drug
medicine.medical_specialty business.industry media_common.quotation_subject 030226 pharmacology & pharmacy Pediatric drug 03 medical and health sciences 0302 clinical medicine 030225 pediatrics Pediatrics Perinatology and Child Health medicine Dosing Intensive care medicine business Dose selection media_common |
| Zdroj: | Pediatric Clinics of North America. 64:1185-1196 |
| ISSN: | 0031-3955 |
| DOI: | 10.1016/j.pcl.2017.08.015 |
| Popis: | Pediatric legislation has generated information about the efficacy, safety, and dosing of more than 600 products in children. Extrapolation of adult efficacy data has been an integral part of pediatric drug development. Advances in our understanding of physiology and pharmacology have improved the approach to pediatric dose selection. However, a high percentage of pediatric trials do not meet their primary efficacy endpoint. Delays in initiating completing pediatric studies persist. This article describes these advances and provides innovative approaches to optimize pediatric drug development. |
| Databáze: | OpenAIRE |
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