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Therapeutic Innovation & Regulatory Science|July 31, 2025
Longitudinal Descriptive Analysis of Dynamic Changes in Safety Concerns in Japanese Risk Management Plans for Medicinal Products Over 8 Years After ApprovalChieko Ishiguro, Mahiro Sazawa, Takahiro Nonaka
Therapeutic Innovation & Regulatory Science|August 11, 2021
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic FindingsGrace Omes-Smit, Marjolein Garsen, Alex Zwiers
Therapeutic Innovation & Regulatory Science|June 10, 2020
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank MeetingTrevor A Lentz, Lesley H Curtis, Frank W Rockhold, et al.
Therapeutic Innovation & Regulatory Science|June 12, 2020
Characteristics on Drug Safety Measures in Japan Stratified by System Organ Classes and Therapeutic Categories in Relation to the Approval DateAyaka Hiramatsu, Hideki Hanaoka, Yoshiaki Uyama
Therapeutic Innovation & Regulatory Science|July 21, 2025
Transforming Objective Participatory Patient AdvocacyPat Furlong, Timothy R Franson, Peter J Pitts
Therapeutic Innovation & Regulatory Science|July 21, 2025
Post-marketing Safety Assessment of CAR T-cell Therapies: Analysis of Individual Case Safety Reports in the VigiBaseMeshael M AlRasheed, Solaiman M AlHawas, Nora N AlOrf, et al.
Therapeutic Innovation & Regulatory Science|July 27, 2025
Optimizing Biomedical Health Efficiency: Unlocking the Full Potential of Life Science Innovation Through System DesignGigi Hirsch, Sharon E Phares, Jane Barlow, et al.
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