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Therapeutic Innovation & Regulatory Science|May 5, 2026
Advancing Wider Implementation of Multi-regional Clinical Trials in East AsiaJohn H Skerritt, Irene Chan, Aloka ChakravartyTherapeutic Innovation & Regulatory Science|April 12, 2026
Does the Epoch-Making Guideline Need Instructions for Use?: Analyzing Adverse Events Collected through Selective Safety Data Collection Under ICH E19 Guideline with Addressing Implementation ConsiderationsHayato Niiyama, Takuji Komeda, Ayako Kitami, et al.Therapeutic Innovation & Regulatory Science|April 4, 2026
Power Calculation for Non-inferiority Test Based on Linear Combination of Two Correlated Binary EndpointsHaojia Song, Shein-Chung ChowTherapeutic Innovation & Regulatory Science|April 7, 2026
The Future of Biologics: Lessons from Hatch-WaxmanBrian J Miller, Janet WoodcockTherapeutic Innovation & Regulatory Science|March 25, 2026
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 GuidelinesHiroyuki Yoshida, Yasuhiro Abe, Miho Kasuga, et al.Therapeutic Innovation & Regulatory Science|May 11, 2026
Critical to Quality Assessment Methodology: An Adaptable Clinical Trial Risk Management and Quality Assurance Approach for Quality Functions in Pharmaceutical Companies, Developed by the Inter-Company IMPALA ConsortiumKiernan Trevett, Jennifer Emerson, Paula Walker, et al.Therapeutic Innovation & Regulatory Science|May 14, 2026
Interpreting Non-Inferiority Across Effect Scales: A Bayesian Perspective with Clinical TranslationDanila Azzolina, Silvia Bressan, Mohd Rashid Khan, et al.Therapeutic Innovation & Regulatory Science|May 7, 2026
Therapeutic Horizon in Multiple Myeloma: Analysis of the Emerging Landscape of Clinical TrialsMarina Alacoque Rodrigues, Cristiane Aparecida Menezes de Pádua, Paula Lana de Miranda Drummond, et al.Therapeutic Innovation & Regulatory Science|May 12, 2026
Impact of Japanese Subpopulation Data and Overall Survival in Pivotal Trials on Oncology Drug Approvals in JapanTakanobu Watanabe, Ikuo Sugiyama, Hideyuki KondoTherapeutic Innovation & Regulatory Science|February 20, 2020
Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into PracticeC H Mallinckrodt, J Bell, G Liu, et al.Pageof 165