Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 18. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-04-01 to 2025-04-01.)
ArticleCitations
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 202480
Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance52
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux48
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information35
Data Monitoring Committee Reports: Telling the Data’s Story30
A Global Industry Survey on Post-Approval Change Management and Use of Reliance29
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China28
An Extended Framework of Multiple Testing in Group Sequential Design27
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study26
Adoption of Decentralization: Are Our Perceptions Holding Us Back?24
Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease24
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry23
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis22
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data22
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space22
The Data Monitoring Committee: A Collective or a Collection?22
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in 22
The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power20
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States18
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