The Analysis and Enlightenment of DSMB Application in Pediatric Drugs Clinical Trials

Zhang L.; Huang J.; Wen Y.

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The Analysis and Enlightenment of DSMB Application in Pediatric Drugs Clinical Trials

机译：DSMB应用在儿科药物临床试验中的分析与启示

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《Drug safety: An international journal of medical toxicology and drug experience》 |2019年第10期|共1页
作者
Zhang L.; Huang J.; Wen Y.;
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Beijing Univ Chinese Med Dept Sci Res Dongfang Hosp Beijing Peoples R China;

Beijing Univ Chinese Med Dongfang Hosp Beijing Peoples R China;

Beijing Univ Chinese Med Dongfang Hosp Beijing Peoples R China;

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正文语种 eng
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1. The Analysis and Enlightenment of DSMB Application in Pediatric Drugs Clinical Trials [J] . Zhang L., Huang J., Wen Y. Drug safety: An international journal of medical toxicology and drug experience . 2019,第10期

机译：DSMB应用在儿科药物临床试验中的分析与启示
2. Analysis of human immunodeficiency virus type 1 drug resistance in children receiving nucleoside analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir (Pediatric AIDS Clinical Trials Group 377). [J] . Eshleman SH, Krogstad P, Jackson JB, The Journal of Infectious Diseases . 2001,第12期

机译：分析接受核苷类似物逆转录酶抑制剂加奈韦拉平，奈非那韦或利托那韦的儿童的1型人类免疫缺陷病毒耐药性（小儿艾滋病临床试验组377）。
3. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries [J] . Markus Hartmann Trials . 2012,第1期

机译：欧洲临床试验指令的影响评估：一项纵向，前瞻性，观察性研究，分析自2001年以来提交给六个欧盟国家监管机构的临床药物试验申请的方式和趋势
4. The Application of Generalized Linear Model in Interaction Effect Analysis in Clinical Trials of New Drugs of Traditional Chinese Medicine [C] . Wang Jing, Hu Jingqing 2012 IEEE 5th International conference on management engineering amp; technology of statistics . 2012

机译：广义线性模型在中药新药临床试验相互作用效应分析中的应用
5. A Comparative Analysis of Recruitment Methods used in Randomized Controlled Clinical Drug Trials [D] . Garud, Ashwini. 2019

机译：随机对照临床药物试验中招募方法的比较分析
6. Pediatric Cardiovascular Clinical Trials: An Analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database [O] . Kevin D. Hill, Heather T. Henderson, Christoph P. Hornik, -1

机译：儿科心血管临床试验：ClinicalTrials.gov和食品药品监督管理局儿科药物标签数据库的分析
7. Education and enlightenment of clinical pharmacology. Ideal way of clinical trial for drugs and standpoint of citizen. [O] . NOBUO SEO 1997

机译：临床药理学教育与启示。毒品临床试验的理想方式和公民的角度。
8. FDA Resource Manual for Clinical Investigations: Regulations, Guidelines, and Other References for Conducting Clinical Trials under Investigational New Drug Applications [R] . Couig, M. P. 1991

机译：FDa临床研究资源手册：在研究性新药申请下进行临床试验的法规，指南和其他参考文献

The Analysis and Enlightenment of DSMB Application in Pediatric Drugs Clinical Trials

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