提高注射类新药Ⅰ期临床试验给药精准性的探讨  

Exploration on increasing administration accuracy of injectable new drugs in Phase Ⅰ clinical trials

作　　者：杨丹丹[1] 江波[1] 胡殷[1] 管燕璐 蒋倩倩 阮邹荣[1] YANG Dan-dan;JIANG Bo;HU Yin;GUAN Yan-lu;JIANG Qian-qian;RUAN Zou-rong(Center of Clinical Pharmacology,The Second Affiliated Hospital,School of Medicine,Zhejiang University,Hangzhou 310009,China)

机构地区：[1]浙江大学医学院附属第二医院临床药理中心,杭州310009

出　　处：《中国新药杂志》2021年第20期1871-1874,共4页Chinese Journal of New Drugs

基　　金：浙江省医药卫生科研项目青年人才项目(2018RC037)。

摘　　要：药物Ⅰ期临床试验是新药研发中临床阶段的首要历程,临床各环节数据的准确性、真实性、可溯源性至关重要。注射类药物的给药不同于临床常规,其特殊性要求研究人员更加精确的把控涉及药物相关的各个细节:给药量的精确计算及配置、经密仪器的使用及准确的输注、实际给药量计算等。本中心已完成多个注射类新药的Ⅰ期临床试验,本文总结了上述各个环节中的工作体会,为注射类新药临床试验实施提供经验,提高给药的精准性,充分保障受试者安全,确保临床试验质量。Phase Ⅰ clinical trial is the most important course in the clinical stage of new drug discovery and development.The accuracy,authenticity,and traceability of clinical data in each step are of crucial importance.The administration of injectable medicines in phase Ⅰ clinical trial is different from routine practice,and its particularity requires researchers to control all the details related to medicines more accurately,which include accurate calculation and dispensing of dosage,accurate infusion speed and observation,calculation of actual dosage,etc.We have completed several phase Ⅰ clinical trials of injectable drugs.This paper summarized our experience in each aspect above-mentioned.This not only provides experience for the implementation of injectable medicine clinical trials,but also fully help protect the safety of subjects and ensures the quality of clinical trials.

关 键 词：注射类新药 Ⅰ期临床试验 精准性 

分 类 号：R969.4[医药卫生—药理学]