期刊
PHARMACEUTICS
卷 13, 期 1, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics13010044
关键词
pediatric pharmacology; juvenile pig model; translational research; drug discovery; drug development; drug safety; PBPK
资金
- European Union's Horizon 2020 program [777554]
- University of Antwerp [26733, 34479, 42354]
- Research Foundation Flanders (FWO) [G0D0520N]
- Herculesstichting [AUHA/13/006]
- Ellegaard Gottingen Minipigs Re-search Foundation [34237]
The use of neonatal and juvenile animal models, particularly pigs, in pediatric drug discovery and development shows promising potential for assessing drug safety and understanding disease mechanisms. However, limitations and unexplored aspects of this large animal model still need to be addressed for further development of nonclinical safety models for pediatric drug development.
Pharmacotherapy in pediatric patients is challenging in view of the maturation of organ systems and processes that affect pharmacokinetics and pharmacodynamics. Especially for the youngest age groups and for pediatric-only indications, neonatal and juvenile animal models can be useful to assess drug safety and to better understand the mechanisms of diseases or conditions. In this respect, the use of neonatal and juvenile pigs in the field of pediatric drug discovery and development is promising, although still limited at this point. This review summarizes the comparative postnatal development of pigs and humans and discusses the advantages of the juvenile pig in view of developmental pharmacology, pediatric diseases, drug discovery and drug safety testing. Furthermore, limitations and unexplored aspects of this large animal model are covered. At this point in time, the potential of the neonatal and juvenile pig as nonclinical safety models for pediatric drug development is underexplored.
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