European regulatory perspective on pediatric physiologically based pharmacokinetic models

Autor:	Elisa Luzon, Justin L. Hay, Anna Nordmark, Susan Cole, Ine Skottheim Rusten
Rok vydání:	2017
Předmět:	03 medical and health sciences Physiologically based pharmacokinetic modelling 0302 clinical medicine Risk analysis (engineering) business.industry 030220 oncology & carcinogenesis Medicine Disposition Pharmacology business 030226 pharmacology & pharmacy Pediatric drug Pediatric population
Zdroj:	International Journal of Pharmacokinetics. 2:113-124
ISSN:	2053-0854 2053-0846
DOI:	10.4155/ipk-2016-0025
Popis:	Physiologically based pharmacokinetic (PBPK) models offer a mechanistic understanding of the disposition of the drug in the body. When well informed and conducted, this may lead to more efficient clinical studies in the vulnerable pediatric population. A review of pediatric submissions to European regulatory authorities has shown a limited number of recent examples. The use of PBPK models to inform pediatric drug development is encouraged. It is, however, important to consider the confidence in the predictions. A qualification of the PBPK platform for the intended purpose should be performed, and a learn-and-confirm approach is recommended. Further research in this area is encouraged to inform important parameters, and to increase availability of pediatric data for model qualification.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::fd31b1f10beb949509f77e5cefce209b https://doi.org/10.4155/ipk-2016-0025 Zobrazit plný text záznamu