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Therapeutic Innovation & Regulatory Science|February 3, 2020
Investigation of the Influencing Factors on the Incidence of Vertebral Fracture: A Meta-analysis Based on Placebo Data of Randomized Clinical TrialsTsuyoshi Kobayashi, Masayuki Kaneko, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|February 3, 2020
Risk-Based Monitoring Approach to Ensure the Quality of Clinical Study Data and Enable Effective MonitoringAyano Higa, Michie Yagi, Kenta Hayashi, et al.Therapeutic Innovation & Regulatory Science|September 25, 2020
Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member CompaniesPriya Patel, Rania Gaspo, Annamaria Crisan, et al.Therapeutic Innovation & Regulatory Science|September 22, 2020
Drivers of Start-Up Delays in Global Randomized Clinical TrialsJennifer Lai, Leila Forney, Daniel L Brinton, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA MethodologyNoraisyah Mohd Sani, Neil McAuslane, Siti Hidayah Kasbon, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?Björn Koneswarakantha, Timothé Ménard, Donato Rolo, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA MethodologyNoraisyah Mohd Sani, Neil McAuslane, Siti Hidayah Kasbon, et al.Therapeutic Innovation & Regulatory Science|September 1, 2020
Correction to: Optimal Decision Criteria for the Study Design and Sample Size of a Biomarker‑Driven Phase III TrialAkira Takazawa, Satoshi MoritaTherapeutic Innovation & Regulatory Science|September 30, 2020
Update of EMA's Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human UseRalf Arno WessTherapeutic Innovation & Regulatory Science|January 4, 2021
Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial DataKimie Sai, Eiji Nakatani, Yasuhiro Iwama, et al.Pageof 165