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Therapeutic Innovation & Regulatory Science|May 12, 2024
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 GuidelinesRominder Singh, William Wang, Aloka Chakravarty, et al.Therapeutic Innovation & Regulatory Science|May 9, 2024
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical TrialsGeorge Wu, Spencer Childress, Zhongkai Wang, et al.Therapeutic Innovation & Regulatory Science|May 29, 2024
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical SitesDaniel O' Mahony, Alan Lynch, Olivia McDermottTherapeutic Innovation & Regulatory Science|May 21, 2024
New Estimates on the Cost of a Delay Day in Drug DevelopmentZachary P Smith, Joseph A DiMasi, Kenneth A GetzTherapeutic Innovation & Regulatory Science|May 24, 2024
Performance Evaluation of Interim Analysis in Bioequivalence StudiesNaoki Isogawa, Andy Grieve, Ryota Ishii, et al.Therapeutic Innovation & Regulatory Science|April 23, 2024
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in OncologyAkio Maki, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|April 10, 2024
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event DataYuki Nakagawa, Takashi SozuTherapeutic Innovation & Regulatory Science|February 6, 2026
Quantifying Eligibility Pattern Shifts: a Data-Driven Paradigm for Early Risk Detection in Clinical TrialsAtanu Bhattacharjee, Ayon MukherjeeTherapeutic Innovation & Regulatory Science|February 12, 2026
Viral Clearance: Safety and Efficiency of BiopharmaceuticalsShahin Vahora, Bhavesh Patel, Nishant Talati, et al.Therapeutic Innovation & Regulatory Science|December 11, 2025
Patent Term Extension for Innovative Drugs in China: A Cohort Study from 2021 to 2024Xuefang Yao, Yan Zhang, Jin ZhouPageof 165