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Therapeutic Innovation & Regulatory Science|September 19, 2018
Using Contour Plots to Assess the Sensitivity of Clinical Trial Design AssumptionsRichard C Zink, Xiaotong Jiang
Therapeutic Innovation & Regulatory Science|September 19, 2018
Establishing Return-on-Investment Expectations for Patient-Centric InitiativesKenneth A Getz
Therapeutic Innovation & Regulatory Science|September 19, 2018
Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and OutlineAnn Meeker-O'Connell, Maria Magdalena Borda, Janis A Little, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management PlanScott Brand, Diana Bartlett, Mary Farley, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and InsulinsStella Stergiopoulos, Carrie A Brown, Gustavo Grampp, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Structured Benefit-Risk Assessment Across the Product Lifecycle: Practical ConsiderationsMeredith Y Smith, Isma Benattia, Carmit Strauss, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Improving the Quality of Compounded Sterile Drug Products: A Historical PerspectiveSusan A Cantrell
Therapeutic Innovation & Regulatory Science|September 19, 2018
Improving Regulatory Education: Can We Reconcile Employers' Expectations With Academic Offerings?Daniela Drago, Sandra Shire, Ozgur Ekmekci
Therapeutic Innovation & Regulatory Science|September 19, 2018
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to ImplementationDuane Schulthess, Lynn G Baird, Mark Trusheim, et al.
Therapeutic Innovation & Regulatory Science|September 19, 2018
Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting DatabaseAyami Ichida, Hideyuki Motohashi, Asuka Kitano, et al.
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