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Therapeutic Innovation & Regulatory Science|September 20, 2018
Expanding Consumer Medication Access: The Time Is NowSally A Huston, Suzan Kucukarslan, Harshali K Patel, et al.Therapeutic Innovation & Regulatory Science|September 20, 2018
Changes to Prescription Drug Pediatric Labeling: Awareness by Practicing PediatriciansIrwin G Martin, Siva Rama Krishna Thottempudi, Daniel A C FrattarelliTherapeutic Innovation & Regulatory Science|January 9, 2023
Examining Endpoint Concordance in Clinical Trials and Real-World Clinical Practice to Advance Real-World Evidence UtilizationDebra Schaumberg, Kay Larholt, Elizabeth Apgar, et al.Therapeutic Innovation & Regulatory Science|December 19, 2022
A Flexible Ensemble Learning Method for Survival ExtrapolationRan Dai, Jihyun Ma, Meijing Wu, et al.Therapeutic Innovation & Regulatory Science|January 3, 2023
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent TailsKentaro Ueno, Satoshi MoritaTherapeutic Innovation & Regulatory Science|August 28, 2021
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical TrialsMarcin Makowski, Ruma Bhagat, Soazig Chevalier, et al.Therapeutic Innovation & Regulatory Science|August 30, 2021
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic CharacteristicsZ Smith, M Wilkinson, C Carney, et al.Therapeutic Innovation & Regulatory Science|August 18, 2021
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in JapanAkari Tanaka, Hirofumi Suzuki, Satoshi Toyoshima, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Choosing a Mobile Sensor Technology for a Clinical Trial: Statistical Considerations, Developments and LearningsColleen Russell, Marie McCarthy, Joseph C Cappelleri, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
FDA's Generic Drug Program: Decreasing Time to Approval and Number of Review CyclesHoward Chazin, Jason Woo, Jing Han, et al.Pageof 165