Drug safety evaluation in pediatric population: Research advances / 国际药学研究杂志

ABSTRACT

The safety and risk assessment of pediatric pharmaceuticals has become a hot spot on drug development and management in recent years. The shortage and unreasonable use of pediatric medicines and lack of preclinical juvenile safety evaluation of marketed pharmaceuticals have caused safety problems, a serious threat to the health and safety of pediatric population. Therefore,governments have formulated relevant regulative and administrative regulations and policies. In preclinical research, due to the similarity of the young animals and children in the development process, a series of juvenile animal studies were carried out and the respective guidelines were gradually improved in Europe and the US. Therefore, the toxic effects of pharmaceuticals on children can be effectively predicted. In this paper, a detailed analysis and explanation is provided on the difficulties confronted with on R&D of pediatric pharmaceuticals, physiological differences between children and adults, and particularly, the importance and focus of preclinical safety evaluation of pediatric pharmaceuticals, in order to offer a reference for the safety evaluation of pediatric drugs in China.