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Therapeutic Innovation & Regulatory Science|May 17, 2021
Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master TrialLen Rosenberg, Hugh Levaux, Ross L Levine, et al.Therapeutic Innovation & Regulatory Science|May 10, 2021
Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011-2017Paul R Jones, Elisabeth J Walther, Andrew Nguyen, et al.Therapeutic Innovation & Regulatory Science|June 10, 2020
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical ReviewYodit Seifu, Margaret Gamalo-Siebers, Friederike M-S Barthel, et al.Therapeutic Innovation & Regulatory Science|May 31, 2020
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its DocumentationMagdalena Bujar, Neil McAuslane, Patricia Connelly, et al.Therapeutic Innovation & Regulatory Science|June 13, 2020
Characteristics of Drug Intervention Clinical Trials and Scientific Impact of the Trial Outcome: A Bibliometric Analysis Using the Relative Citation Ratio in Non-small Cell Lung Cancer from 2007 to 2016Yutaka Noguchi, Masayuki Kaneko, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|June 13, 2020
AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study DataNicole Mentenich, Christoph Tasto, Bastian BeckerTherapeutic Innovation & Regulatory Science|April 29, 2021
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular EntitiesCatherine Feng, Riddhi Virparia, Eric T-K MuiTherapeutic Innovation & Regulatory Science|June 20, 2020
The New Drug Lag: EU Lags in Review Times of Monoclonal AntibodiesVibha Sharma, Vivek Dasharath Deore, Sandhya Vivek Deore, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and SafetyWinona Rei R Bolislis, Charlie Mortazavi, Rossana Riccioni, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory EnvironmentA O Kaliaev, M A MalikovaPageof 165