ABSTRACT
The safety and risk assessment of pediatric pharmaceuticals has become a hot spot on drug development and man?agement 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,gov?ernments 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 effective?ly 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 safe?ty evaluation of pediatric pharmaceuticals,in order to offer a reference for the safety evaluation of pediatric drugs in China.
ABSTRACT
There is an increasing demand for neonatal and juvenile animal toxicity studies during the research and development of new drugs. In this paper,we discussed general evaluation parameters of pediatric non-clinical safety with pediatric drugs,such as growth and development and food intake,and paramenters of other organs and systems, such as the central nervous system,reproductive system, behavior evaluation in combination with our own experience. In addition,the characteristics of non-clin?ical safety evaluation of new traditional Chinese medicine materia medica used for juvenile animals were analyzed. This paper is intended reference for non-clinical safety evaluation of pediatric drugs and to gain some experience related to formulation of new guidelines.
ABSTRACT
In current research and development of new drugs,the demand for toxicological study using neonatal and juvenile animals is becoming increasingly urgent. In this paper,we discussed the characteristics,importance and necessity of nonclinical safety evaluation for pediatric drugs,considerations for research design,selection of animal species and age,route and duration of drug administration and evaluation indexes. In addition,the characteristics of nonclinical safety evaluation of new traditional Chinese materia medica used for children were analyzed. It is hoped that these studies will not only provide support and reference for nonclinical safety evaluation of pediatric drugs but help accumulate material in formulating relevant guidelines.
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.