Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005

Louise Berendt; Cecilia Håkansson; Karin F. Bach; Per B. Andreasen; Lene G. Petersen; Elin Andersen; Henrik E. Poulsen; Kim Dalhoff

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Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005

机译：学术性临床药物试验的方法学特征– 1993-2005年在丹麦药品管理局的应用回顾性队列研究

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来源
《British Journal of Clinical Pharmacology》 |2010年第5期|p.729-735|共7页
作者
Louise Berendt; Cecilia Håkansson; Karin F. Bach; Per B. Andreasen; Lene G. Petersen; Elin Andersen; Henrik E. Poulsen; Kim Dalhoff;
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作者单位

The GCP unit at Copenhagen University Hospital, Bispebjerg Hospital|Danish Medicines Agency;

Danish Medicines Agency;

|The GCP unit at Copenhagen University Hospital, Bispebjerg Hospital;

The GCP unit at Copenhagen University Hospital, Bispebjerg Hospital;

|Danish Medicines Agency;

Danish Medicines Agency;

Department of Clinical Pharmacology, Rigshospitalet|Faculty of Health Sciences, University of Copenhagen|Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark;

Department of Clinical Pharmacology, Bispebjerg Hospital, Copenhagen, Denmark;

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正文语种 eng
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关键词
academic; clinical research; clinical trial methodology; clinical trial; investigator-initiated; non-commercial;

机译：学术;临床研究;临床试验方法论;临床试验;研究者发起的;非商业的;

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1. Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005. [J] . Berendt L, Hakansson C, Bach KF, British Journal of Clinical Pharmacology . 2010,第5期

机译：学术临床药物试验的方法学特征-一项针对1993-2005年在丹麦药物管理局的应用的回顾性队列研究。
2. Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005 [J] . Louise Berendt, Cecilia H?kansson, Karin F. Bach, British journal of clinical pharmacology . 2010,第5期

机译：学术临床药物试验的方法学特征–一项针对1993-2005年在丹麦药品管理局的应用的回顾性队列研究
3. Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis [J] . Kohara Norihito, Kaneko Masayuki, Narukawa Mamoru Therapeutic innovation & regulatory science. . 2019,第1期

机译：研究影响临床试验质量的研究特征的调查，该协议偏差导致从每种协议中排除受试者的研究，在新药物应用中的研究中设定数据：回顾性分析
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. Retrospective Analysis of Phase 3 Clinical Trial to Evaluate the Efficacy of Drug B in Anemia Secondary to Chronic Kidney Disease [D] . Pollard, Kellyn 2019

机译：第3期临床试验的回顾性分析，评价患有慢性肾病的贫血药物B的疗效
6. Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005 [O] . Louise Berendt, Cecilia Håkansson, Karin F Bach, 2010

机译：学术性临床药物试验的方法学特征– 1993-2005年在丹麦药品管理局的应用回顾性队列研究
7. Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005 [O] . Berendt, Louise, Håkansson, Cecilia, Bach, Karin F, 2010

机译：学术性临床药物试验的方法学特征– 1993-2005年在丹麦药品管理局的应用回顾性队列研究

Methodological characteristics of academic clinical drug trials – a retrospective cohort study of applications to the Danish Medicines Agency 1993–2005

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