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Therapeutic Innovation & Regulatory Science

IF1.9
Papers103
Citations
Journal Papers 103
Publication Date
Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical Trials
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deleteKuwahara, Takahiro; Kidena, Ryota; Kato, Naoki; Okamoto, Rika; Hagimori, Naoko; Kawamoto, Atsuhiko
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Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania
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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
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deleteTennant, Bethany L.; Koenig, Teresa; Bennett-Harper, Sarah; Chance, Sarah; O'Donoghue, Amie C.; Sullivan, Helen W.
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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
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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
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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
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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
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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
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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
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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
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deleteEl-Kassas, Mohamed; AlNaamani, Khalid M.; Alswat, Khalid; Younossi, Zobair M.
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Pharmacoeconomic Evaluation of Netupitant Palonosetron for Chemotherapy-Induced Nausea and Vomiting: Evidence from Economic Analyses
delete2026-05-01
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deleteZhang, Meiyan; Zhang, Fan; Tian, Chen; Zhang, Yunjin; Wang, Chenghui; Zhang, Hongnan; Zhang, Lei
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The Future of Biologics: Lessons from Hatch-Waxman
delete2026-04-01
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deleteMiller, Brian J.; Woodcock, Janet
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