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 2021-09-01 to 2025-09-01.)
ArticleCitations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study59
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States51
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry39
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs36
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux34
Anti-lung Cancer Marine Compounds: A Review34
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry32
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review28
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States27
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data27
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names26
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials26
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned23
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System23
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases22
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China22
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today21
Decentralized Clinical Trials in the Development of Drugs and Biological Products20
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis19
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