Therapeutic Innovation & Regulatory Science

Papers
(The H4-Index of Therapeutic Innovation & Regulatory Science is 13. 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 2020-03-01 to 2024-03-01.)
ArticleCitations
The Use of External Controls in FDA Regulatory Decision Making53
Real World Evidence in Medical Cannabis Research37
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design34
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 Initiative23
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action19
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 Regulati16
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View16
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 201916
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors15
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies15
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review14
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation14
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative13
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry13
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters13
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments13
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