Commentary on the EMA Guideline EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products

Gerven Joop; Bonelli Milton

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Commentary on the EMA Guideline EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products

机译：EMA指南EMA指南识别和减轻与调查药品的先发制人和早期临床试验风险的策略指南的评论

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来源
《British Journal of Clinical Pharmacology》 |2018年第7期|共9页
作者
Gerven Joop; Bonelli Milton;
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作者单位

Central Committee on Research Involving Human Subjects CCMOThe Hague The Netherlands;

Human Medicines Research and Development Support DivisionEuropean Medicines AgencyLondon UK;

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原文格式 PDF
正文语种 eng
中图分类药理学;
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1. Commentary on the EMA Guideline EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products [J] . Gerven Joop, Bonelli Milton British Journal of Clinical Pharmacology . 2018,第7期

机译：EMA指南EMA指南识别和减轻与调查药品的先发制人和早期临床试验风险的策略指南的评论
2. Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design [J] . The European journal of psychiatry. . 2016,第1期

机译：治疗精神分裂症的新药物的临床试验设计：EMA指南的讨论和更好的长期试验设计
3. Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design [J] . Jiang Haibiao, Jiangsu Hansoh Pharmaceutical China, Mental Health Center of Minhang District Shanghai China, The European Journal of Psychiatry (Spanish Edition) . 2016,第1期

机译：治疗精神分裂症的新药物的临床试验设计：EMA指南的讨论和更好的长期试验设计
4. An electronic diary software for ecological momentary assessment (EMA) in clinical trials [C] . Vahabzadeh, M., Epstein, . 2004

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5. Clinical Practice Guideline for Differentiating Risks Factors for Avoidable and Unavoidable Pressure Ulcers [D] . Suárez Irizarry, Vivian 2018

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6. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products [O] . Joop van Gerven, Milton Bonelli 2018

机译：关于EMA指南的评论该指南旨在确定和减轻使用研究性药物进行的首次人类和早期临床试验的风险
7. P465 UC trial designed more than 5 years ago in the light of the EMA guideline on the development of new medicinal products for the treatment of ulcerative colitis [O] . R Laoun, R Hofmann 2019

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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

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Commentary on the EMA Guideline EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products

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