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Therapeutic Innovation & Regulatory Science|September 12, 2026
Beyond prediction: an evidenced-based framework for assessing site selection decisionsAnh Ninh, Linh Vu, Daniel ButlerTherapeutic Innovation & Regulatory Science|September 15, 2026
Regulatory Reliance in Latin America: Opportunities and Implementation Challenges for International Pharmaceutical CompaniesEsteban Ortiz-Prado, Jorge Vasconez-Gonzalez, Dina Albuja Tapia, et al.Therapeutic Innovation & Regulatory Science|November 22, 2022
Efficacy and Safety of Ophthalmic Preparations of Glucocorticoids in Patients with Epidemic Keratoconjunctivitis: A Systematic Review and Meta-analysisPengpeng Liu, Guangyao Li, Mei Han, et al.Therapeutic Innovation & Regulatory Science|May 28, 2021
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug DevelopmentTimothé Ménard, Alaina Barros, Christopher GanterTherapeutic Innovation & Regulatory Science|May 27, 2021
Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral ExplanationAlexandra Oger, Aimad Torqui, Robert Kester, et al.Therapeutic Innovation & Regulatory Science|January 29, 2020
Optimal Decision Criteria for the Study Design and Sample Size of a Biomarker-Driven Phase III TrialAkira Takazawa, Satoshi MoritaTherapeutic Innovation & Regulatory Science|January 5, 2023
Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical TrialsShinya Watanabe, Takahiro Nonaka, Makoto Maeda, et al.Therapeutic Innovation & Regulatory Science|January 11, 2023
Some Thoughts on the Use of Predictive Probability in Clinical TrialsHeng Li, Manuela Buzoianu, Adrijo Chakraborty, et al.Therapeutic Innovation & Regulatory Science|December 20, 2022
Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020Hyeyoung Choi, Hyesung Lee, Bojung Park, et al.Therapeutic Innovation & Regulatory Science|December 21, 2022
Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical TrialsYongming Qu, Robin D White, Stephen J RubergPageof 165