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 2021-08-01 to 2025-08-01.)
ArticleCitations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study57
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States50
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry38
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs34
Anti-lung Cancer Marine Compounds: A Review34
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux33
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials31
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned27
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review26
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data26
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States25
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry25
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names22
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China21
Decentralized Clinical Trials in the Development of Drugs and Biological Products21
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis20
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases19
Real World Evidence in Medical Cannabis Research19
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System19
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