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
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names30
Anti-lung Cancer Marine Compounds: A Review30
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs30
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
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
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review23
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
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China20
Decentralized Clinical Trials in the Development of Drugs and Biological Products20
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance19
0.20203399658203