Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 14. 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 2020-04-01 to 2024-04-01.)
ArticleCitations
The Use of External Controls in FDA Regulatory Decision Making54
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design38
Real World Evidence in Medical Cannabis Research38
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials30
Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative25
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 Regulati19
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action19
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies18
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 201916
Assessing the Financial Value of Decentralized Clinical Trials16
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review15
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors15
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments14
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation14
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