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Therapeutic Innovation & Regulatory Science

IF1.9
Papers78
Citations
Journal Papers 78
Publication Date
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The Future of Biologics: Lessons from Hatch-Waxman
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-04-01
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PREAI
deleteMiller, Brian J.; Woodcock, Janet
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Measurement or Judgment? Reconsidering Data Quality and Inference in EudraVigilance
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-04-01
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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
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-04-01
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deleteSong, Haojia; Chow, Shein-Chung
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Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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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
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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deleteStockbridge, Norman; Southworth, Mary Ross
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RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteTaylor, Lockwood; Adamson, Blythe
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Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteYan, Charles; Yang, Ruier; Yan, Huaihai; Wei, Xin; Zhou, Erkang; Zhao, Shouzhu; Zhuang, Yonglong
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Lessons and Insights from a Case Study on Clinical Trial Fraud
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteMcGuire, Courtney; Sellers, Jenn W.; Grandinetti, Cheryl; Fedowitz, Michele; Ayalew, Kassa
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Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph plus ALL with Immature Efficacy Data
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteAshaye, Ajibade; Thomas, Caitlin; Kota, Vamsi; Krucien, Nicolas; Marsh, Kevin
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Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting Neurodevelopment
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteFarmer, Cristan; Kim, Victoria; Das, Tanvi; Cutler, Seth; Wallis, Heidi; Thurm, Audrey
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Metformin as an Adjunct in Periodontal Therapy: Mechanistic Insights, Research Evidence and Current Challenges
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteAlasbily, Hamza; Elburki, Muna Saad
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Statistical Guardrails for Hybrid-Controlled Trials: Robust to Confounding and Between-Study Heterogeneity
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteRan, Di; Zhang, Fanni; Broglio, Kristine; Shahsavari, Sima; Henderson, Alasdair; Yu, Binbing
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Assessing the Contribution of Components in Late-Phase Oncology Trials: A Roadmap of Key Approaches
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteTian, Xiaowen; Broglio, Kristine; Ran, Di; Zhang, Jianliang; Li, Xia
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Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteHall, Kathryn E.; Bernhardt, Jean M.
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Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 Guidelines
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteYoshida, Hiroyuki; Abe, Yasuhiro; Kasuga, Miho; Makino, Kohei; Kuribayashi, Ryosuke; Takagi, Kazunori; Morita, Tokio; Goda, Yukihiro; Sato, Yoji
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Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework Recommendation
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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deleteFlood, Emuella; Karlsson, Niklas; Ostridge, Jennifer; Kirova, Bistra; Sullivan, Tim; Zorenyi, Gyorgy; Valastro, Barbara; Park, Jiyoon
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An NCI Micro-credentialing Model for Onboarding and Training Clinical Research Professionals in a Lean Fiscal Environment
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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deleteTafuto, Barbara; Zhang, Belinda; Black, Kathleen; Watkins-Keller, Ginnette; Mittal, Rahul; Demarco, Barbara
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Enhancing Data Quality in Clinical Trials: Cross-Company Validation of the Open-Source Clinical Trial Anomaly Spotter (CTAS)
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteTiikkainen, Pekka; Collin, Frederik; Koneswarakantha, Bjorn
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Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from US FDA Approvals
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteSaito, Kaku; Narukawa, Mamoru
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Challenges and Potential Solutions to Advance Global Cancer Drug Development
deleteTherapeutic Innovation & Regulatory Science
IF1.9
delete2026-03-01
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PREAI
deleteGlasmacher, Axel; Lyerly, Kim; Wolf, Birgit; Zapella, Pio; Zielinska, Lidia; Clark, Emma; Mauer, Murielle; Paiva, Bruno; Schiel, Anja; Sweeney, Fergus; Uyl-de Groot, Carin A.; Von Lilienfeld-Toal, Marie; Verweij, Jaap
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