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Therapeutic Innovation & Regulatory Science|March 17, 2021
Interdisciplinary Safety Evaluation for Learning and Decision-MakingGreg Ball, Barbara A Hendrickson, Amy L Freedman, et al.
Therapeutic Innovation & Regulatory Science|November 17, 2021
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice RenovationKenichi Nakamura, Hitoshi Ozawa, Taro Shibata, et al.
Therapeutic Innovation & Regulatory Science|August 29, 2019
The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of DevicesBeata Wilkinson, Robert van Boxtel
Therapeutic Innovation & Regulatory Science|January 25, 2021
Review of the Food and Drug Administration's Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Acknowledgment Letters and Filing CommunicationsJennifer Riddle Camp, Jillian Venci Fuhs, Scott D Beattie, et al.
Therapeutic Innovation & Regulatory Science|January 3, 2022
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development, Jennifer Clark, Natalia Muhlemann, et al.
Therapeutic Innovation & Regulatory Science|January 6, 2022
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in OncologyKristine Broglio, Jayne Marshall, Binbing Yu, et al.
Therapeutic Innovation & Regulatory Science|February 22, 2022
Memory-Assisted Global Impression of Change (MAGIC)Linda S Deal, David A Andrae, Daniela E Myers, et al.
Therapeutic Innovation & Regulatory Science|February 10, 2022
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published StudiesBill Byrom, Celeste A Elash, Sonya Eremenco, et al.
Therapeutic Innovation & Regulatory Science|June 20, 2019
Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in JapanKentaro Sakamaki, Seitaro Yoshida, Yusuke Morita, et al.
Therapeutic Innovation & Regulatory Science|April 26, 2022
Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of EfficacyAllison Dunn, Dawoon Jung, Lisa L Bollinger, et al.
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