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Therapeutic Innovation & Regulatory Science

IF1.9
论文数99
被引数
期刊论文 99
发表时间
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Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical Trials开发一种新型风险评估量表以提高临床试验中基于风险方法的一致性和可靠性
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-07-01
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PREAI
deleteKuwahara, Takahiro; Kidena, Ryota; Kato, Naoki; Okamoto, Rika; Hagimori, Naoko; Kawamoto, Atsuhiko
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Twenty-Five Years of FDA Prescription-to-Nonprescription Switch Approvals (2001-2025)2001-2025年FDA处方药转为非处方药的审批历程回顾
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteIamukova, Liudmila
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Advancing Wider Implementation of Multi-regional Clinical Trials in East Asia推动东亚多区域临床试验的更广泛实施
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-07-01
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deleteOAAI
deleteSkerritt, John H.; Chan, Irene; Chakravarty, Aloka
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Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania对坦桑尼亚临床试验评估人员和伦理审查人员进行培训需求评估和能力建设，以加强监管审查
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteMwamwitwa, Kissa W.; Munishi, Castory G.; Makoye, Paul Malaba; Maganga, Aisha M.; Chambiri, Sunzy M.; Nyondo, Goodluck G.; Mlugu, Eulambius M.; Mwalwisi, Yonah H.; Oriyo, Ndekya; Ally, Mayassa S.; Simai, Burhani O.; Sabiiti, Wilber; Mmbaga, Blandina T.; Mloka, Doreen; Ntinginya, Nyanda E.; Fimbo, Adam M.; Kaale, Eliangiringa A.
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Clinicians' Reactions to Point-of-Care Advertising in Electronic Health Records临床医生对电子健康记录中即时处方的广告的反应
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-07-01
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PREAI
deleteTennant, Bethany L.; Koenig, Teresa; Bennett-Harper, Sarah; Chance, Sarah; O'Donoghue, Amie C.; Sullivan, Helen W.
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Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System与克拉斯可特龙相关的不良事件：一项基于美国食品药品监督管理局不良事件报告系统的真实世界药物警戒研究
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteTao, Li; Zhang, Mengying; Zhang, Wenyue; Feng, Peishi; Zhou, Min; Wang, Ping
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Comparative Assessment of the Pharmaceutical Quality of Amoxicillin Capsules Marketed in Authorized and an Unregulated Point of Sale in Mexican Market比较在墨西哥市场授权销售点和非授权销售点销售的阿莫西林胶囊的药品质量评估
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-07-01
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deleteMarmolejo-Bernal, Gael; Mejia-Amaro, Leny; Benitez-Escamilla, Teresa; Castillo-Granada, Alberta Lourdes; Cruz-Antonio, Leticia
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Analyses of US FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024美国FDA GCP评估分析和营销申请建议，2015-2024
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteMcGuire, Courtney; Foringer, Michelle; Burrow, David; Sellers, Jenn; Grandinetti, Cheryl; Ayalew, Kassa
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Therapeutic Horizon in Multiple Myeloma: Analysis of the Emerging Landscape of Clinical Trials多发性骨髓瘤的治疗前景：临床 trial 新兴格局分析
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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deleteRodrigues, Marina Alacoque; de Padua, Cristiane Aparecida Menezes; de Miranda Drummond, Paula Lana; Malta, Jessica Soares; Reis, Adriano Max Moreira
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Pharmacovigilance Data From Digital Health Systems: Regulations, Implications, and Opportunities-A TransCelerate Perspective数字健康系统中的药物警戒数据：法规、影响与机遇——转加速（TransCelerate）视角
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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deleteWhitehead, James; Ghosh, Rajesh; Monaco, Anna; Grissinger, Jackie; Neyman, Inessa; Umrath, Tom; Craun, Clint
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Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective日本药品上市后安全性评价的现状与未来：PMDA的视角
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IF1.9
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deleteWaki, Takashi; Watanabe, Shinya; Ando, Takashi; Kajiyama, Kazuhiro; Fukuda, Koichi; Iwasa, Eiko; Iwasaki, Yukari; Iwagami, Masao; Tanaka, Taihei; Maeda, Daisuke; Uyama, Yoshiaki
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Web-based Dossier Management System (DMS) and Emerging Technologies to Facilitate Faster Registration and Access to Human Drugs: NAFDAC's Experience基于网络的档案管理系统（DMS）及新兴技术以促进人类药物更快注册和获取：NAFDAC的经验
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteAdeyeye, Mojisola Christianah; Sonny-Afoekelu, Uche; Ogbeide, Edosa; Akinyemi, Abayomi Tosin; Ayodele, Ake Paul; Balogun, Olufemi; Olasupo, Sabitu Babatunde
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Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change为何中东和北非地区的MASLD临床试验入选不足，以及赞助商和监管机构必须做出的改变
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IF1.9
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PREAI
deleteEl-Kassas, Mohamed; AlNaamani, Khalid M.; Alswat, Khalid; Younossi, Zobair M.
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Missing Data Handling in the Application of Matching-Adjusted Indirect Comparison匹配调整间接比较应用中的缺失数据处理
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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deleteFang, Yixin; Li, Moming; Lai, Jeff; He, Weili
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The Future of Biologics: Lessons from Hatch-Waxman生物制剂的未来：来自哈奇-沃克斯曼法案的启示
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-04-01
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deleteMiller, Brian J.; Woodcock, Janet
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Measurement or Judgment? Reconsidering Data Quality and Inference in EudraVigilance测量还是判断？重新审视EudraVigilance中的数据质量和推论
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteLei, Zhihao
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Power Calculation for Non-inferiority Test Based on Linear Combination of Two Correlated Binary Endpoints基于两个相关二分类终点的线性组合的非劣效性检验的功效计算
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-04-01
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PREAI
deleteSong, Haojia; Chow, Shein-Chung
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Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland波兰全国性横断面研究：临床试验的伦理与监管意识
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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PREAI
deleteSwieczkowski, Damian; Burzynski, Jacek; Kwasny, Aleksander; Pruc, Michal; Szarpak, Lukasz; Cubala, Wieslaw Jerzy
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Letter to the Editor: Battle Won but War Lost for Barth Syndrome Patients致编辑函：巴特综合征患者：一役已胜，战争未休
deleteTherapeutic Innovation & Regulatory Science
IF1.9
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deleteStockbridge, Norman; Southworth, Mary Ross
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RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities真实世界证据向欧洲监管机构和支付方的提交：挑战、不确定性与机遇
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IF1.9
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PREAI
deleteTaylor, Lockwood; Adamson, Blythe
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