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Use of Proprietary Names by Prescribers for Generic Products JOURNAL ARTICLE published March 2018 in Therapeutic Innovation & Regulatory Science |
Vulnerability and Clinical Research: Mapping the Challenges for Stakeholders JOURNAL ARTICLE published September 2020 in Therapeutic Innovation & Regulatory Science |
Data-Driven Subgroup Identification in Confirmatory Clinical Trials JOURNAL ARTICLE published January 2022 in Therapeutic Innovation & Regulatory Science |
Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials JOURNAL ARTICLE published January 2020 in Therapeutic Innovation & Regulatory Science |
Investigation of Characteristics of Japanese Clinical Trials in Terms of Data Variability JOURNAL ARTICLE published July 2013 in Therapeutic Innovation & Regulatory Science |
Editor-in-Chief’s Commentary: Collaborate to Innovate JOURNAL ARTICLE published March 2014 in Therapeutic Innovation & Regulatory Science |
Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey JOURNAL ARTICLE published September 2018 in Therapeutic Innovation & Regulatory Science Research funded by Ministry of Health, Labour and Welfare (Health Labour Sciences Research Grant (Japan), res) |
Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) JOURNAL ARTICLE published March 2019 in Therapeutic Innovation & Regulatory Science |
Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGE JOURNAL ARTICLE published January 2017 in Therapeutic Innovation & Regulatory Science |
Multifaceted Paths Toward Advancing Regulatory Science JOURNAL ARTICLE published July 2015 in Therapeutic Innovation & Regulatory Science |
DIA Then and Now: A Half-Century Odyssey JOURNAL ARTICLE published September 2017 in Therapeutic Innovation & Regulatory Science |
A Practical Estimation Method for Analyzing Adverse Drug Reactions Using Data Mining JOURNAL ARTICLE published March 2013 in Therapeutic Innovation & Regulatory Science |
Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan JOURNAL ARTICLE published July 2018 in Therapeutic Innovation & Regulatory Science |
Managing Team Innovation in the Research and Development (R&D) Organization: Critical Determinants of Team Effectiveness JOURNAL ARTICLE published November 2015 in Therapeutic Innovation & Regulatory Science |
Using Individual Experiences With Experimental Medications to Predict Medication-Taking Behavior Postauthorization: A DIA Study Endpoints Workstream JOURNAL ARTICLE published July 2017 in Therapeutic Innovation & Regulatory Science |
A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products JOURNAL ARTICLE published May 2017 in Therapeutic Innovation & Regulatory Science |
Who Stands to Benefit? Right to Try Law Provisions and Implications JOURNAL ARTICLE published March 2017 in Therapeutic Innovation & Regulatory Science |
An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees JOURNAL ARTICLE published September 2015 in Therapeutic Innovation & Regulatory Science |
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission JOURNAL ARTICLE published September 2020 in Therapeutic Innovation & Regulatory Science |
Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape JOURNAL ARTICLE published January 2017 in Therapeutic Innovation & Regulatory Science |