Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 21. 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 2022-06-01 to 2026-06-01.)
ArticleCitations
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States58
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry53
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names50
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials47
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study47
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review43
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals39
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial36
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux36
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data34
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs32
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry30
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States28
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers26
Accelerating Global Access for Indication Extension Through Regulatory Reliance Pilot: The First Indication Extension Pilot in Oncology26
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea25
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System25
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis25
A Generalization of the Two Trials Paradigm23
Pharmacometrics: The Already-Present Future of Precision Pharmacology23
Decentralized Clinical Trials in the Development of Drugs and Biological Products21
0.58818984031677