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Therapeutic Innovation & Regulatory Science|October 26, 2020
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and ImpactKevin Bugin, Janet Woodcock, Peter Stein, et al.Therapeutic Innovation & Regulatory Science|October 28, 2020
Quantitative Benefit-Risk Assessment: State of the Practice Within IndustryMeredith Y Smith, Janine van Til, Rachael L DiSantostefano, et al.Therapeutic Innovation & Regulatory Science|October 6, 2020
Characteristics of Industry-Sponsored Drug Clinical Trials Registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010-2018Eriko Kobayashi, Midori Matsuyama, Katsue Suzuki, et al.Therapeutic Innovation & Regulatory Science|July 30, 2021
Data-Driven Subgroup Identification in Confirmatory Clinical TrialsPierre Bunouf, Mélanie Groc, Alex Dmitrienko, et al.Therapeutic Innovation & Regulatory Science|July 19, 2021
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working GroupJames Buchanan, Mengchun Li, Xiao Ni, et al.Therapeutic Innovation & Regulatory Science|June 3, 2022
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance IndicatorsHamza Y Garashi, Douglas T Steinke, Ellen I SchafheutleTherapeutic Innovation & Regulatory Science|June 10, 2022
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant DiversityKenneth Getz, Maria Florez, Emily Botto, et al.Therapeutic Innovation & Regulatory Science|June 14, 2022
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 TrialSamvel B Gasparyan, Joan Buenconsejo, Elaine K Kowalewski, et al.Therapeutic Innovation & Regulatory Science|January 4, 2021
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in JapanSono Sawada, Takashi Ando, Mai Hirano, et al.Therapeutic Innovation & Regulatory Science|May 28, 2021
Addressing Bias in Responder Analysis of Patient-Reported OutcomesJoseph C Cappelleri, Richard ChambersPageof 165