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儿童是新药研发的特殊群体,很多药品都没有儿童的临床研究数据,导致儿童超说明书用药现象十分严重,存在临床安全隐患。随着对于儿童用药安全的日益关注,开展规范化的多中心儿童药物临床试验迫在眉睫。如何开展儿科新药临床研究,成为儿科医师、药师及药物临床试验机构人员急需掌握的知识和技能。由中华医学会儿科学分会儿科临床药理学专业组和《中华儿科杂志》编辑委员会主办,北京大学第一医院儿科和首都医科大学附属北京儿童医院及汉
Children are a special group of new drug research and development, many of the drugs do not have children’s clinical research data, resulting in children over manual phenomenon is very serious, there are clinical safety hazards. With the growing concern about the safety of children’s medicines, it is imperative to carry out standardized clinical trials of multi-center children’s medicines. How to carry out pediatric new drug clinical research has become a pediatrician, pharmacist and drug clinical trial agency personnel urgently need to master the knowledge and skills. By the Chinese Medical Association of Pediatrics Pediatrics clinical pharmacology professional group and “Chinese Journal of Pediatrics” Editorial Committee, Peking University First Hospital pediatric and Beijing Capital Medical University Affiliated Beijing Children’s Hospital and Han