药物制剂安全性研究评价的常见问题讨论  

Discussion on common issues in the safety evaluation of preparations

作　　者：尹茂山 李峥 尹华静 王寅 吴爽 周恒 付淑军 于冰 王庆利 YIN Mao-shan;LI Zheng;YIN Hua-jing;WANG Yin;WU Shang;ZHOU Heng;FU Shu-jun;YU Bing;WANG Qing-li(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2023年第11期1667-1672,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：药物制剂经非口服途径给药,对给药局部产生的毒性、刺激性和/或对全身产生过敏性和溶血性等均属于制剂安全性的范畴,是药物非临床安全性评价的重要组成部分。药物制剂安全性评价中经常出现不规范或不符合指导原则等科学规范问题,无法为临床试验和用药提供足够的非临床安全性信息。本文结合审评工作中发现的相关问题进行讨论,以期为申请人及安评机构在开展药物制剂安全性评价时提供借鉴。Pharmaceutical preparations administered through non oral routes have toxicity,irritation and/or systemic allergic and hemolytic effects,all of which fall within the scope of drug safety.And it is an important component of non clinical drug safety evaluation.Scientific and normative issues such as non-standard or non compliant guidelines often arise in the safety evaluation of drug formulations,which can’t provide sufficient non clinical safety information for clinical trials and medication.This article discusses the relevant issues found in the review process,with a view to providing reference for applicants and safety assessment institutions in conducting safety assessments of pharmaceutical preparations.

关 键 词：制剂安全性 非临床研究 安全性 刺激性试验 过敏性试验 溶血性试验 生物制品变更 药物非临床研究质量管理规范 

分 类 号：R97[医药卫生—药品]