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Therapeutic Innovation & Regulatory Science|August 5, 2025
Ensuring Quality and Interpretability of Progression Free Survival and Overall Survival in Oncology Clinical TrialsPhilip He, Haijun Ma, Chengxing Cindy Lu, et al.Therapeutic Innovation & Regulatory Science|March 27, 2025
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level AnalysisRichard Z Xie, Tess Cameron, Peter KolchinskyTherapeutic Innovation & Regulatory Science|November 25, 2020
The Integrated Review: FDA Modernizes the Review of New Drug Marketing ApplicationsRhonda M Hearns-Stewart, John Farley, Kerry Jo Lee, et al.Therapeutic Innovation & Regulatory Science|October 24, 2020
Comparative Assessment of Non-trial Access to Investigational Medical Products in the U.S. and JapanHaruka Nakada, Kelly McBride Folkers, Kyoko TakashimaTherapeutic Innovation & Regulatory Science|November 9, 2020
Identifying Anticipated Events of Future Clinical Trials by Leveraging Data from the Placebo Arms of Completed TrialsXiang-Lin Tan, David M Kern, M Soledad CepedaTherapeutic Innovation & Regulatory Science|September 9, 2020
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and PerspectivesJeremiah D Momper, Dionna J Green, Kyunghun Park, et al.Therapeutic Innovation & Regulatory Science|December 24, 2022
Bayesian Strategies in Rare DiseasesUrsula Garczarek, Natalia Muehlemann, Frank Richard, et al.Therapeutic Innovation & Regulatory Science|December 26, 2022
Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial PatientsZhen Peng, Yan Ma, Jumei Wang, et al.Therapeutic Innovation & Regulatory Science|January 13, 2021
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019Judith P Ter Horst, Sada L Turimella, Frans Metsers, et al.Therapeutic Innovation & Regulatory Science|July 1, 2021
elaborator: A Novel App for Insights into Laboratory Data of Clinical TrialsSilke Janitza, Madhurima Majumder, Franco Mendolia, et al.Pageof 165