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
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea20
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis20
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System19
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