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Therapeutic Innovation & Regulatory Science|September 18, 2018
Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose SelectionBret Musser, James Bolognese, Ghassan N Fayad, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination ProductsMarilyn Tsourounis, Jeffrey Stuart, MaryAnn Smith, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral DrugsJeremiah D Momper, Yang Chang, Matthew Jackson, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
APEC Workshop Report of Good Review Practices on Medical ProductsHsien-Yi Lin, Steven Jun-Yi Chen, Churn-Shiouh Gau, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Statistical Challenges in the Analyses of Bone Mineral Density in Pediatric PopulationsPhillip DinhTherapeutic Innovation & Regulatory Science|September 18, 2018
Monitoring and Evaluating the Effect of Regulatory Action: Some Recent Case StudiesAndrew Thomson, Wilhelmine Hadler Meeraus, Jenny Wong, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report FormsMary Elizabeth Sabol, John Finkle, Mitch Krucoff, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
A Descriptive Evaluation of Prescriber Perceptions and Experience With Risk Evaluation and Mitigation Strategy (REMS) Programs in an Integrated Health Care SystemNazia Rashid, T Craig Cheetham, Gustavus Aranda, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Reduction in Medication Errors: The Fentora Case StudyGopal Reddy Palvatla, Irwin G MartinTherapeutic Innovation & Regulatory Science|September 18, 2018
Management of Clinical Trial Agreements: Current Practices of Investigators in the United StatesJoAnn P Pfeiffer, Frances J RichmondPageof 165