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Therapeutic Innovation & Regulatory Science|October 30, 2023
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in JapanTomoaki Hasegawa, Sono Sawada, Tomoyuki Saito, et al.Therapeutic Innovation & Regulatory Science|March 28, 2024
International Comparison of Qualification Process for Medical Product Development ToolsDaichi Uchijima, Shingo KanoTherapeutic Innovation & Regulatory Science|March 28, 2024
Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) ReportsMalak Almutairi, Aljoharah Algabbani, Ajbaa Alasiri, et al.Therapeutic Innovation & Regulatory Science|March 26, 2024
Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy EndpointsShinya Watanabe, Takahiro Nonaka, Makoto Maeda, et al.Therapeutic Innovation & Regulatory Science|August 14, 2023
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal EvidenceFrancesco Scaglione, Paola Minghetti, Francesco Ambrosio, et al.Therapeutic Innovation & Regulatory Science|January 5, 2024
US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel TherapiesJoseph M Gendy, Naomi Nomura, Jeffrey N Stuart, et al.Therapeutic Innovation & Regulatory Science|December 22, 2023
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning ModelTakashi Watanabe, Kaori Ambe, Masahiro TohkinTherapeutic Innovation & Regulatory Science|November 22, 2023
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality DevicePeter Baker, Tamika Cathey, Jared R AuclairTherapeutic Innovation & Regulatory Science|March 4, 2024
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial PerformanceKenneth Getz, Zachary Smith, Emily Botto, et al.Therapeutic Innovation & Regulatory Science|January 29, 2024
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan AfricaArmel Zemsi, Lorraine Jinette Guedem Nekame, Nuredin Mohammed, et al.Pageof 165