2020
DOI: 10.1002/cpt.2076
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Regarding Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

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“…Traditionally, the approval of a pediatric indication is supported by clinical trials conducted in pediatric patients to characterize the PK/PD profiles and/or to demonstrate effectiveness and safety. There can be a significant delay between the approval in adults and labeling in pediatric patients 12 . MIDD in recent years has been commonly applied for dose selection and optimization to facilitate pediatric drug development based on the exposure matching principle 13 .…”
Section: Pediatric Extrapolation Of Drugs Approved/authorized To Treat Covid‐19mentioning
confidence: 99%
“…Traditionally, the approval of a pediatric indication is supported by clinical trials conducted in pediatric patients to characterize the PK/PD profiles and/or to demonstrate effectiveness and safety. There can be a significant delay between the approval in adults and labeling in pediatric patients 12 . MIDD in recent years has been commonly applied for dose selection and optimization to facilitate pediatric drug development based on the exposure matching principle 13 .…”
Section: Pediatric Extrapolation Of Drugs Approved/authorized To Treat Covid‐19mentioning
confidence: 99%
“…По данным FDA на 2018 г., около 50% всех клинических испытаний как малых молекул, так и БЛП не дают должной информации относительно эффективности и безо пасности лекарств у детей младше 12 лет. Средний промежуток времени между появлением рекомендаций по дозированию у детей составляет 9 лет после утверждения инструкции у взрослых [26]. При этом необходимо отметить, что информацию о лекарствах для детейот дозирования до различных эффектов -получают не только после клинических исследований, но также через экстраполяцию («косвенная» или «интуитивная», полная и частичная «доказательная» экстраполяции) [27].…”
Section: моноклональные антитела в педиатрии и неонатологииunclassified