医学
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全部论文审稿周期
15 篇有效样本 · 按发表日期由新到旧排列
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Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context
作者Daniele Napolitano; Mattia Bozzetti; Rosario Caruso; Monica Guberti; Ileana Frau; Bobbi Smuck; Gionata Fiorino; Franco Scaldaferri; Lucrezia Laterza; Antonio Gasbarrini; Vincenzina Mora
作者单位1. Scientific Direction – Fondazione Policlinico Universitario IRCCS, Università Cattolica del Sacro Cuore Rome, Rome, Italy; 2. Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy; 3. Direction of Health Professions, ASST Cremona, Cremona, Italy; 4. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy; 5. Health Professions Research and Evidence Transfer Unit, IRCCS MultiMedica, Sesto San Giovanni, Italy; 6. Nursing and Allied Health Professions, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy; 7. Ass. Prime Site Director, Strategic Site Solutions EMEA - IQVIA, Milan, Italy; 8. Department of Ophthalmology, Ivey Eye Institute, St. Joseph’s Health Care, London, Canada; 9. Gastroenterology and Digestive Endoscopy, San Camillo-Forlanini Hospital, Rome, Italy; 10. Centro Malattie dell’Apparato Digerente (CEMAD), Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?
作者Revathi Ananthakrishnan; Patrick Mitchell; Dong Xi; Gu Mi; Gina D’Angelo; Haijun Ma; Yujun Wu; Philip He
作者单位1. Bristol-Myers Squibb (BMS), Princeton, USA; 2. AstraZeneca (AZ), Gaithersburg, USA; 3. Gilead, Foster City, USA; 4. Sanofi, Cambridge, USA; 5. Revolution Medicines, Redwood City, USA; 6. Oncolytics Biotech Inc, San Diego, USA; 7. Daiichi Sankyo, Inc, Basking Ridge, USA
Current Status and Construction Requirements of Drug Clinical Trial Institutions in Sichuan Province in China
作者Shuxia Shi; Shangyuan Qin; Qin Yu
作者单位1. National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China; 2. NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, China; 3. Children’s Medicine Key Laboratory of Sichuan Province, Chengdu, China; 4. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China; 5. Department of Pharmacy, Chengdu Fifth People’s Hospital, Chengdu, China
The CARE Program: An Initiative of Patient-Focused Drug Development for Rare Diseases by NMPA
作者Ling Tang; Songmei Xie; Lijia Yuan; Xiaowen Xu; Xing Ai; Tian Zhao; Zhimin Yang
作者单位1. Center for Drug Evaluation, National Medical Products Administration, Beijing, The People’s Republic of China
Utilization of Clinical Evaluation Reports in Japan’s Medical Device Approvals: Insights from Review Data on Approved Devices
作者Koji Yamada; Daisuke Obata; Jun Matsubayashi; Mayumi Yamanaka; Akiko Hinomura; Hiromu Kutsumi; Shin-ya Morita; Shu Kasama
作者单位1. Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Japan; 2. Asahi Kasei Medical Co., Ltd., Tokyo, Japan; 3. Clinical & Translational Research Center, Kobe University Hospital, Kobe, Japan; 4. Medical Research Support Center, University of Fukui Hospital, Eiheiji-cho, Yoshida-gun, Fukui, Japan; 5. Department of Pharmacotherapeutics, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Japan
Quantifying the Financial Return on Investment of Risk-Based Quality Management Implementation in Clinical Development
作者Abigail Dirks; Sylviane de Viron; Kenneth McFarlane; Kenneth A. Getz
作者单位1. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, USA; 2. Clue Points S.A, Louvain-la-Neuve, Belgium; 3. CluePoints Inc, King of Prussia, USA
Identifying and Deploying Benchmarks for Clinical Research at Sites
作者Rida Momin; Laura Mangiarini; Alexandre Dias Tavares Costa; Carla Peacock; Emaad Shariff; Sara Noorain; Jennifer Preston; Sabah Attar
作者单位1. Northern Care Alliance NHS Foundation Trust, Greater Manchester, UK; 2. Fondazione Penta ETS, Padova, Italy; 3. Instituto Carlos Chagas (ICC/Fiocruz Paraná), Rio de Janeiro, Brazil; 4. Innovate R Ltd., Manchester, UK; 5. Groundmark Learning, Leamington Spa, UK; 6. University of Liverpool, Liverpool, UK
Real-World Evidence for Drug Approvals: Moving Toward Greater Regulatory Clarity
作者Tala H. Fakhouri; Rasika Kalamegham; Nicole Mahoney; Rose Purcell; Mike D’Ambrosio
作者单位1. Parexel International, Maryland, USA; 2. Genentech, Washington, DC, USA; 3. Novartis, Rockville, USA; 4. Takeda, Washington, DC, USA
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