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Therapeutic Innovation & Regulatory Science|June 7, 2021
Patient Engagement Initiatives in Clinical Trials: Recent Trends and ImplicationsShalome Sine, Annick de Bruin, Kenneth GetzTherapeutic Innovation & Regulatory Science|June 21, 2021
New Visualization Models of Designation Pathway and Group Categorization of Cell-Device and Protein-Device Combination Products in the United StatesNobuo Uemura, Hiroshi Kasanuki, Mitsuo UmezuTherapeutic Innovation & Regulatory Science|December 3, 2022
Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member CountriesPedro Franco, Ritesh Jain, Elizabeth Rosenkrands-Lange, et al.Therapeutic Innovation & Regulatory Science|June 26, 2022
Risk Management in Drug-Device Combination Product DevelopmentRobin Kumoluyi, Amit KhanolkarTherapeutic Innovation & Regulatory Science|September 12, 2020
Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in JapanKento Takamura, Keisuke Tachibana, Tetsunari Kihira, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Establishing Consensus Understanding of the Barriers to Drug Development in LupusYaritza Peña, Karin Tse, Leslie M Hanrahan, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Study Designs in Multi-arm Trials for Breast Cancer: A Systematic Literature Review of Major JournalsShogo Nomura, Yu Miyauchi, Yoshikazu Ajisawa, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South AfricaAndrea Keyter, Sam Salek, Neil McAuslane, et al.Therapeutic Innovation & Regulatory Science|September 2, 2020
Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical TrialsYiming Chen, John Lawrence, H M James Hung, et al.Therapeutic Innovation & Regulatory Science|December 10, 2020
A Comparison Between a Meta-analytic Approach and Power Prior Approach to Using Historical Control Information in Clinical Trials With Binary EndpointsNaoki Isogawa, Kentaro Takeda, Kazushi Maruo, et al.Pageof 165