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Therapeutic Innovation & Regulatory Science|October 25, 2016
Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug DevelopmentAnn W McMahon, Kevin Watt, Jian Wang, et al.Therapeutic Innovation & Regulatory Science|August 15, 2019
Nonclinical Immunotoxicity Testing in the Pharmaceutical World: The Past, Present, and FuturePaul BaldrickTherapeutic Innovation & Regulatory Science|August 30, 2019
Development of Performance Indicators for Clinical Research Coordinators Using the Balanced Scorecard in South KoreaYoun Sun Hwang, Tae Wha LeeTherapeutic Innovation & Regulatory Science|May 8, 2015
Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical ResultsFrederick Curro, Van P Thompson, Frederick Naftolin, et al.Therapeutic Innovation & Regulatory Science|May 8, 2015
Advances in Statistical Approaches Oncology Drug DevelopmentAnastasia Ivanova, Gary L Rosner, Olga Marchenko, et al.Therapeutic Innovation & Regulatory Science|August 26, 2025
Beyond Screen Formats: Towards Context-Aware, Patient-Centric ePRO Design in Clinical TrialsSchawanya Kaewpitoon Rattanapitoon, Nav La, Patpicha Arunsan, et al.Therapeutic Innovation & Regulatory Science|August 28, 2025
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New FormatMasahiro Kobayashi, Momo Watanabe, Mika Maeda, et al.Therapeutic Innovation & Regulatory Science|September 6, 2025
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder InterviewsZilke Claessens, Grace Beirne, Catherine Decouttere, et al.Therapeutic Innovation & Regulatory Science|May 29, 2020
eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway : The Time Has Come for Advertising and Promotion to Submit in Module OneJoanne Hathaway, Kevin Hom, Boris Reznichenko, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Use of Proprietary Names by Prescribers for Generic ProductsVicky Borders-Hemphill, Irene Z Chan, Katelyn Brown, et al.Pageof 165