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 2022-08-01 to 2026-08-01.)
ArticleCitations
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States64
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry58
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names56
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study55
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials41
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review40
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux39
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial33
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs31
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry30
Accelerating Global Access for Indication Extension Through Regulatory Reliance Pilot: The First Indication Extension Pilot in Oncology29
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States29
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers28
Expertise of European Clinical Trial Units in Conducting and Managing Cross-Border Pediatric Clinical Trials for Rare Diseases26
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data26
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals25
Career Paths to Drug Development and Regulatory Science Through the U.S. Food and Drug Administration21
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis20
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea20
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System19
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