Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 16. 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 2020-11-01 to 2024-11-01.)
ArticleCitations
The Use of External Controls in FDA Regulatory Decision Making70
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design44
Real World Evidence in Medical Cannabis Research43
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials33
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 201925
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action24
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulati24
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies23
Assessing the Financial Value of Decentralized Clinical Trials23
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments18
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future18
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements18
Factors Affecting Success of New Drug Clinical Trials18
Effective Data Sharing as a Conduit for Advancing Medical Product Development17
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases17
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine16
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned16
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 202116
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors16
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