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Therapeutic Innovation & Regulatory Science|April 24, 2026
Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting SystemLi Tao, Mengying Zhang, Wenyue Zhang, et al.
Therapeutic Innovation & Regulatory Science|May 11, 2026
Dasatinib-Associated Chylothorax: A Scoping Review and Pharmacovigilance AnalysisEleonora Castellana, Patricia Madalina Budau, Cecilia Miglietta, et al.
Therapeutic Innovation & Regulatory Science|December 15, 2025
An Industry Perspective on Compassionate Use in Europe: A Call for ChangePhilipp Schlatter, Nina Heiss, Pedro Franco, et al.
Therapeutic Innovation & Regulatory Science|July 4, 2020
Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies, Mary Elmer, Cathy Florek, et al.
Therapeutic Innovation & Regulatory Science|July 11, 2026
Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic RationaleMasahiro Kobayashi, Moeka Ogawa, Tatsuya Okuwaki, et al.
Therapeutic Innovation & Regulatory Science|June 13, 2023
AI/ML in Precision Medicine: A Look Beyond the HypeZhiheng Xu, Bipasa Biswas, Lin Li, et al.
Therapeutic Innovation & Regulatory Science|August 22, 2022
Japanese Regulatory Considerations for Interoperability of Medical DevicesKazuma Ishimoto, Tatsuhiko Arafune, Toshikatsu Washio, et al.
Therapeutic Innovation & Regulatory Science|September 20, 2018
Multi-domain Longitudinal Modeling: An Application to the International Index of Erectile FunctionAndrew G Bushmakin, Joseph C Cappelleri, Tara Symonds, et al.
Therapeutic Innovation & Regulatory Science|November 7, 2019
When Context Is Hard to Come By: External Comparators and How to Use ThemChristina Mack, Jennifer Christian, Emma Brinkley, et al.
Therapeutic Innovation & Regulatory Science|February 3, 2020
A Practical Perspective: Application of the Generalized Approach for Adaptive DesignJin Wang, Juanjuan Li, Yu Shu, et al.
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