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Therapeutic Innovation & Regulatory Science|May 8, 2021
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study UpdatesBeth Harper, Zachary Smith, Jane Snowdon, et al.
Therapeutic Innovation & Regulatory Science|August 8, 2022
Emergence of New Drugs for Intractable Diseases is Associated with an Increase in the Number of Patients Diagnosed Thereafter with Those Intractable DiseasesToshiya Oka, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|March 17, 2023
An Extended Framework of Multiple Testing in Group Sequential DesignMan Jin, Pingye Zhang
Therapeutic Innovation & Regulatory Science|March 25, 2023
Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the USAkio Maki, Mamoru Narukawa
Therapeutic Innovation & Regulatory Science|March 28, 2023
Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in PeruPercy Herrera-Añazco, Diego Urrunaga-Pastor, Suly Soto-Ordoñez, et al.
Therapeutic Innovation & Regulatory Science|May 20, 2021
The Use of External Controls in FDA Regulatory Decision MakingMahta Jahanshahi, Keith Gregg, Gillian Davis, et al.
Therapeutic Innovation & Regulatory Science|June 5, 2020
Factors that have an Impact on Abbreviated New Drug Application (ANDA) SubmissionsSaranrat Wittayanukorn, Matthew Rosenberg, Andreas Schick, et al.
Therapeutic Innovation & Regulatory Science|June 6, 2020
Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of DrugsNicholas R Harrison, Philip T Sager, Mitchell W Krucoff, et al.
Therapeutic Innovation & Regulatory Science|June 6, 2020
An Empirical Comparison of Statistical Methods for Missing Data in Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trials for Chronic Pain and Lipid-Lowering ProductsJeanine Gnang, Yoonhee Kim, Yi Ren, et al.
Therapeutic Innovation & Regulatory Science|May 25, 2020
Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Trends, Drivers, and Value of Product Support Activities, Key Performance Indicators, and Other Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information DepartmentsMeera Patel, Leena Jindia, Stacey Fung, et al.
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