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Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting Syste
Author: Tao, Li; Zhang, Mengying; Zhang, Wenyue; Feng, Peishi; Zhou, Min; Wang, Ping
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00968-2
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Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontier
Author: Rao, Yanmei; Dong, Li; Huang, Zhe
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-025-00913-9
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Applications and Challenges of Artificial Intelligence and Big Data in Drug Regulatio
Author: Liu, Zhao; Zheng, Yang; Fang, Jun; Yuan, Lin
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00946-8
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Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Revie
Author: Han, Lijia; Ooi, Kai Hong; Balakrishnan, Krisna Veni; Phan, Chia Wei
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00949-5
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Research on the Quality Evaluation Indicators of Real-World Data in the Review of Anti-Tumor Drugs for Chinese Regulatory Framework
Author: Zhang, Jie-ying; Tang, Yong; Dong, Fang-zheng; Mao, Ning-ying; Li, Jun
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00943-x
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Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspectiv
Author: Yan, Charles; Yang, Ruier; Yan, Huaihai; Wei, Xin; Zhou, Erkang; Zhao, Shouzhu; Zhuang, Yonglong
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00953-9
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Patent Analysis Perspectives on China's Orphan Drug R&D: Status and Technology Characteristic
Author: Jiao, Yang; Yuan, Fangzhe; Liu, Tianyu; Han, Jiajia; Sun, Jingchun; Chu, Shuzhen; Li, Shuxiang
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2026; Vol. , Issue , pp. -. DOI: 10.1007/s43441-026-00927-x
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Advancing AI Ethics Frameworks in Drug Development: Global Applicability, Practical Challenges, and Dynamic Governanc
Author: Chen, Kai; Yu, Zekai
Journal: THERAPEUTIC INNOVATION & REGULATORY SCIENCE. 2025; Vol. , Issue , pp. -. DOI: 10.1007/s43441-025-00814-x
