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Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

机译：证据支持欧洲孤儿药品授权的监管决策：方法论不确定性

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Caridad Pontes; Juan Manuel Fontanet; Roser Vives; Aranzazu Sancho; Mònica Gómez-Valent; José Ríos; Rosa Morros; Jorge Martinalbo; Martin Posch; Armin Koch; Kit Roes; Katrien Oude Rengerink; Josep Torrent-Farnell; Ferran Torres;
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1. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs [J] . Enrico Bosone, Mariagrazia Felisi, Stefano Nicotri, BMJ Open . 2017,第9期

机译：在欧洲获得指定后，未能进一步开发孤儿药产品：对销售授权失败和废弃药物的分析
2. METHODOLOGICAL CHARACTERISTICS OF PIVOTAL DATA SUPPORTING ORPHAN MEDICINAL PRODUCTS AUTHORIZED BY THE EMA IN THE FIRST 15 YEARS OF THE ORPHAN REGULATION [J] . Fontanet J. M., Vives R., Pontes C., Basic & clinical pharmacology & toxicology. . 2016,第Suppla1期

机译：重要数据支持EMA批准的头15年中EMA授权的ORPhan药用产品的方法学特征
3. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries [J] . Thomas Morel, Francis Arickx, Gustaf Befrits, Orphanet Journal of Rare Diseases . 2013,第1期

机译：将成本和结果的不确定性与获得孤儿药品的需求相协调：对七个欧洲国家/地区管理性入境协议的比较研究
4. The European Union's Regulatory Framework on Veterinary Medicinal Products [C] . Gudrun Gallhoff Food and Agriculture Organization of the United Nations/World Health Organization Technical Workshop on Residues of Veterinary Drugs Without Acceptable Daily Intake/Maximum Residue Limit . 2004

机译：欧盟对兽医药品的监管框架
5. Development of optimization methodologies for supporting energy systems planning under uncertainty [D] . Lin, Qianguo. 2008

机译：开发不确定性下支持能源系统规划的优化方法
6. Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties [O] . Caridad Pontes, Juan Manuel Fontanet, Roser Vives, 2018

机译：支持欧洲对孤儿药产品授权进行监管决策的证据：方法上的不确定性
7. PSY187 - THE QUANTITY AND QUALITY OF EVIDENCE SUPPORTING EUROPEAN MARKETING AUTHORISATION OF ORPHAN DRUGS: COMPARISON OF RARE ONCOLOGY VERSUS RARE DISEASE [O] . S. Kelly 2018

机译：PSY187 - 支持欧洲营销授权的证据的数量和质量孤儿药物：罕见肿瘤与罕见疾病的比较

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

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