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Comparison of Adverse Drug Reaction Rates in the Package Insert at the Time of New Drug Approval and at Re-Examination

机译：在新药批准时和重新检查时，包装插入中的不良药物反应速率的比较

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Tatsuya WATANABE; Mami IWASAKI; Atsushi UJIHARA; Mamoru NARUKAWA;
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1. The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates [J] . Watanabe Ko, Murakami Masayasu, Masuyama Koichi, Pharmacoepidemiology and drug safety . 2018,第11期

机译：在批准前药物评估期间对不良反应的关注的关联和审批后的临床上显着的不良反应对包装刀片：对预批准预审药物审查报告和安全更新的回顾性分析
2. Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition [J] . Tamura Norio, Ishiguro Chieko, Matsuda Tsutomu Pharmacoepidemiology and drug safety . 2015,第Pta2期

机译：批准后将CSAR附加到药品包装说明书中：不良反应类型和添加时间的分析
3. Rates of spontaneous reports of adverse drug reactions for drugs reported in children: a cross-sectional study with data from the Swedish adverse drug reaction database and the Swedish prescribed drug register. [J] . Wallerstedt SM, Brunlof G, Sundstrom A Drug safety: An international journal of medical toxicology and drug experience . 2011,第8期

机译：儿童药物不良反应的自发报告率：一项横断面研究，数据来自瑞典药物不良反应数据库和瑞典处方药注册机构。
4. A Comparison Study of Search Strategy on Collecting Twitter Data for Drug Adverse Reaction [C] . Arif Dwi Laksito, Kusrini, Heri Sismoro, International Seminar on Application for Technology of Information and Communication . 2018

机译：药物不良反应Twitter数据收集搜索策略的比较研究
5. Evaluation of pregnancy rates following timed AI in beef heifers after synchronization of follicular waves using a 14-d controlled internal drug release insert, and the lifetime productivity of beef heifers conceiving to, or sired by, AI [D] . French, Jesse 2012

机译：使用14 d可控内部药物释放插入物对卵泡波同步后的牛小母牛进行定时AI后的妊娠率评估，以及受AI或由其帮助的小母牛的终生生产力
6. Interrater agreement of two adverse drug reaction causality assessment methods: A randomised comparison of the Liverpool Adverse Drug Reaction Causality Assessment Tool and the World Health Organization-Uppsala Monitoring Centre system [O] . Johannes P. Mouton, Ushma Mehta, Dawn P. Rossiter, -1

机译：两种药物不良反应因果关系评估方法的评估者之间的一致性：利物浦药物不良反应因果关系评估工具与世界卫生组织-乌普萨拉监测中心系统的随机比较
7. Interrater agreement of two adverse drug reaction causality assessment methods: A randomised comparison of the Liverpool Adverse Drug Reaction Causality Assessment Tool and the World Health Organization-Uppsala Monitoring Centre system. [O] . Johannes P Mouton, Ushma Mehta, Dawn P Rossiter, 2017

机译：Interrater同意两种药物不良反应因果关系评估方法：利物浦药品不良反应因果关系评估工具和世界卫生组织 - 乌普萨拉监测中心系统的随机比较。
8. New Animal Drug Applications: An Analysis of Approval Rates, Approval Times, and Deficiencies from 1972 through 1981 [R] . Prunella, P. , Carnevale, R. , Gardner, P. , 1983

机译：新动物药物应用：对1972年至1981年的批准率，批准时间和缺陷的分析

Comparison of Adverse Drug Reaction Rates in the Package Insert at the Time of New Drug Approval and at Re-Examination

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