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Therapeutic Innovation & Regulatory Science|December 10, 2020
Global Pediatric Regulations: An OverviewPriya M Gadge, Prathmesh P Kenjale, Varsha B Pokharkar, et al.
Therapeutic Innovation & Regulatory Science|December 10, 2020
Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting SystemAbhishek Singh, Muthusamy Kalaivani, Sushma Srivastava, et al.
Therapeutic Innovation & Regulatory Science|December 10, 2020
The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of DevicesBeata Wilkinson, Robert van Boxtel
Therapeutic Innovation & Regulatory Science|December 1, 2020
Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research PurposesMary E Ritchey, Cynthia J Girman
Therapeutic Innovation & Regulatory Science|November 26, 2021
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer DesignJulian Quodbach, Malte Bogdahn, Jörg Breitkreutz, et al.
Therapeutic Innovation & Regulatory Science|January 10, 2022
Extrapolation as a Default Strategy in Pediatric Drug DevelopmentMargaret Gamalo, Christina Bucci-Rechtweg, Robert M Nelson, et al.
Therapeutic Innovation & Regulatory Science|November 29, 2021
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient SelectionCynthia Huber, Tim Friede, Julia Stingl, et al.
Therapeutic Innovation & Regulatory Science|November 23, 2021
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune ResponseErika Fujii, Takuya Takata, Hiroko Yamano, et al.
Therapeutic Innovation & Regulatory Science|January 6, 2022
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research ProfessionalsStephen A Sonstein, Lisa Palladino Kim, Nita Ichhpurani, et al.
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