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回顾性分析新药Ⅰ期临床耐受性试验中不良事件的评价方法

Retrospective analysis of evaluation methods of adverse events in the phase Ⅰclinical trial of new drugs
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摘要 目的回顾性分析新药Ⅰ期临床耐受性试验中不良事件的评价方法。方法对4种一类新药(盐酸埃他卡林片、D-聚甘酯注射液、注射重组人胰高血糖素类多肽-1、乳酸卡德沙星氯化钠注射液)的Ⅰ期临床耐受试验不良反应事件,进行分析与讨论。结果 4种新药在设计剂量下,有良好的耐受性,仅有部分受试者出现轻度药物不良反应。结论对新药Ⅰ期临床耐受试验不良反应事件评价及规律探讨,对发现新药不良事件的苗头具有重要意义。 Objective To analyze retrospectively the evaluation methods of adverse events in the phase I clinical trial of new drugs. Methods Four kinds of class 1 new drugs, iptakalim, D - polymannuronicate, rh- GLP - 1 (7 - 36), caderofloxacin were reseached in phase I clinical trim of tolerance and safety to obersevers and analyze the adverse drugs reaction (ADR). Results The four drugs are safe in the designed dose. Conclu- sion The evaluation of tolerance and safety in phase I clinical trial is very important for ADR surveillance of new drugs.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2014年第1期33-35,共3页 The Chinese Journal of Clinical Pharmacology
关键词 I期临床试验 耐受性 安全性 不良事件 phase I clinical trial tolerance safety adverse event
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