Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 19. 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 2021-10-01 to 2025-10-01.)
ArticleCitations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study60
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States53
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux39
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry39
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs37
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials34
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned33
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry30
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data29
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States29
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review28
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names27
Anti-lung Cancer Marine Compounds: A Review24
Pharmacometrics: The Already-Present Future of Precision Pharmacology23
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union23
Real World Evidence in Medical Cannabis Research22
A Generalization of the Two Trials Paradigm22
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data20
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea20
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices19
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