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Therapeutic Innovation & Regulatory Science|November 25, 2025
Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & ChallengesRajkumar Boddu, Arvind Rachapally, Mohammed Shareef Khan, et al.
Therapeutic Innovation & Regulatory Science|November 19, 2025
Drug Repurposing in Oncology: A Strategic Pathway to Unlocking New Therapeutic PotentialRahaman Shaik, Sai Geethika Laddika, Madiha Unnisa, et al.
Therapeutic Innovation & Regulatory Science|December 27, 2024
Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and OpportunitiesConstance Sakala Chisha, Makomani Siyanga, Stephanie Leigh, et al.
Therapeutic Innovation & Regulatory Science|December 20, 2024
Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television AdvertisementsHelen W Sullivan, Kathryn J Aikin, Mihaela Johnson, et al.
Therapeutic Innovation & Regulatory Science|December 21, 2024
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety InformationSatoru Ito, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|January 8, 2025
Interim Clinical Trial Data: Who Can See What, and When?Susan S Ellenberg, Yimei Li
Therapeutic Innovation & Regulatory Science|February 6, 2025
The Ethics of the "Right-to-Try" Movement in an Era of Regulatory FluxNeil Jain, David Ralston, Cheryl Erwin
Therapeutic Innovation & Regulatory Science|December 11, 2024
Risk-Based Quality Management: A Case for Centralized MonitoringNicole Stansbury, Danilo Branco, Cris McDavid, et al.
Therapeutic Innovation & Regulatory Science|December 13, 2024
Mixture Disease Progression Model to Predict and Cluster the Long-Term Trajectory of Cognitive Decline in Alzheimer's DiseaseRyoichi Hanazawa, Hiroyuki Sato, Akihiro Hirakawa, et al.
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