摘要
随着在非生命威胁疾病的治疗领域中广泛、长期使用治疗用药物的需求增多,在研发这些方面的新药时,其安全性更是需要特别关注的问题。本文参考ICH相关指导原则和FDA的上市前风险评估指南,在此提出临床安全性评价的考虑要点。
With the increasing demand for drugs intended for broad,long-term treatment of non-life threatening diseases,safety is of special concern in the research and development of new drugs in these areas.This article raise the main points to consider for clinical safety evaluation in referring to the relevant ICH and FDA pre-market risk assessment guidelines.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2008年第12期1321-1324,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
关键词
评价
上市前
临床安全性
长期治疗用药物
assess
pre-marketing
clinical safety
drugs intended for long-term treatment
