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Therapeutic Innovation & Regulatory Science|August 14, 2026
Exploring the Polyethylene Glycol-Modified Drug Patent Landscape by Deep LearningTingting Zhang, Dechao Deng, Xiaoming Zhang, et al.
Therapeutic Innovation & Regulatory Science|August 26, 2026
AI-Enabled Real-World Evidence in Oncology: A Statistical Perspective for Regulatory DecisionsLei Gao, Dai Feng, Binbing Yu
Therapeutic Innovation & Regulatory Science|August 8, 2026
Clinical and Economic Burden of Diseases with Accelerated Approval Therapies: Evidence of Unmet Patient NeedHanke Zheng, Shanshan Wang, Jason Shafrin, et al.
Therapeutic Innovation & Regulatory Science|July 17, 2026
Quality by Design to Mitigate Aggregation: Mechanistic Insights and Analytical Strategies for Biopharmaceutical ManufacturingAnna Fedorko, Iryna Grynyuk, Jesús Alberto Afonso Urich
Therapeutic Innovation & Regulatory Science|June 9, 2016
A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013Gunter F Egger, Gerold T Wharton, Suzanne Malli, et al.
Therapeutic Innovation & Regulatory Science|February 12, 2025
Evaluation of United Kingdom (UK)-Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines RegulationR B Ankitha, Shailee Dewan, Francis Fernandes, et al.
Therapeutic Innovation & Regulatory Science|February 8, 2025
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study InsightsJyoti Pawar, Namita Hegde, Sanjay Sharma
Therapeutic Innovation & Regulatory Science|January 8, 2025
A Sponsor's Best Practice and Operating Principles to Manage Data Monitoring CommitteesMalene Muusfeldt Birck, Josephine Skovgaard Rasmussen, Ida Carøe Helmark, et al.
Therapeutic Innovation & Regulatory Science|December 29, 2024
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College StudentsGriffin Riggs, Terry David Church
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