Analysis of key considerations in the development of chemical drugs for children
TU Hui-dan
GUO Zhi-xin
WU Xue-ping
YAO Shang-chen
SUN Chun-meng
QI Shu-ye
NING Bao-ming
Abstract：Based on the relevant policies and scientific literature on pediatric medications,this study aims to summarize the key considerations for the development of pediatric drugs in China,providing insights and recommendations for companies involved in pediatric drug development.The clinical needs and relevant policy regulations of oral pediatric drugs were summarized,and the principles of pediatric drug technology guidance and scientific literature were integrated to ultimately outline the fundamental approach for the research and development of oral pediatric drugs.Oral formulations have significant advantages in pediatric administration,and pharmaceutical companies can choose varieties of oral pediatric drugs to develop based on clinical needs.In the formulations research stage,pharmaceutical companies should pay attention to the specificity of pediatric drugs,focus on the physiological and pathological characteristics of different age groups of children,and give priority to small-dosage oral formulations.It is suggested to focus on the safety of excipients while considering their corrective and masking effects on the taste of the drugs.Packaging and drug delivery devices also need to be designed to improve the acceptability of the drugs to pediatric patients.
Keywords：pediatric medicationdrug research and developmentpolicy and regulationsoral pediatric medicationchemical drug development
Publication Date：2024-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2324-2330 )