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Therapeutic Innovation & Regulatory Science|December 1, 2023
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8Madeleine Whitehead, Melissa Suprin, Tashan Mistree, et al.Therapeutic Innovation & Regulatory Science|February 5, 2024
The Finkelstein-Schoenfeld Test: A Note on Some Overlooked Issues Concerning PowerRong Tang, Wei-Chen Chen, Heng Li, et al.Therapeutic Innovation & Regulatory Science|February 6, 2024
A Modified Delphi Study to Establish Essential Clinical Pharmacology CompetenciesBernadette Johnson-Williams, Kellie Reynolds, Joga Gobburu, et al.Therapeutic Innovation & Regulatory Science|March 28, 2024
Adoption of Decentralization: Are Our Perceptions Holding Us Back?Lindsay Kehoe, Sara Bristol Calvert, Zachary Hallinan, et al.Therapeutic Innovation & Regulatory Science|March 26, 2024
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are TodayKaren Zhou, Ginny GattingerTherapeutic Innovation & Regulatory Science|April 2, 2024
An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) ConsortiumBjörn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, et al.Therapeutic Innovation & Regulatory Science|September 10, 2024
Advanced Regenerative Medicines for Rare Diseases: A Review of Industry Sponsors Investment MotivationsUbaka Ogbogu, Anja NelTherapeutic Innovation & Regulatory Science|March 4, 2024
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and ItalyFernanda Lacerda da Silva Machado, Martín Cañás, Martín A Urtasun, et al.Therapeutic Innovation & Regulatory Science|February 20, 2024
Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in MalaysiaWan Lee Chow, Nur Afiqah Mohd Salleh, Tse Siang KangTherapeutic Innovation & Regulatory Science|November 23, 2023
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future DirectionsPei Li, Su Wang, Yuwen ChenPageof 165