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 2021-05-01 to 2025-05-01.)
ArticleCitations
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies82
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study53
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry48
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States39
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry32
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs30
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names30
Anti-lung Cancer Marine Compounds: A Review30
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux28
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States26
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data25
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review23
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned23
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development23
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea22
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action22
Decentralized Clinical Trials in the Development of Drugs and Biological Products20
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China20
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance19
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