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Therapeutic Innovation & Regulatory Science|June 20, 2020
Use of "Big Data" to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical ProductsLesley Reeve, Paul Baldrick, Andrew Newell, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
A Framework for Safety Evaluation Throughout the Product Development Life-CycleGreg Ball, Tjark Reblin, James Buchanan, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Impact of Design on Medical Device SafetyTeodora Miclăuş, Vasiliki Valla, Angeliki Koukoura, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
A Review of the Medical Challenges of Using Direct Oral Anticoagulants in Real-World PracticeIlYoung ChoTherapeutic Innovation & Regulatory Science|June 20, 2020
Toolkit for ICH E6 (R2) Quality Risk Management for Small to Medium Size CompaniesAndrew Della-Coletta, Terry Katz, Kathy Kupka, et al.Therapeutic Innovation & Regulatory Science|June 18, 2020
Benchmarking Patient Recruitment and Retention PracticesMary Jo Lamberti, Zachary Smith, Rhonda Henry, et al.Therapeutic Innovation & Regulatory Science|August 30, 2025
Exploring Diabetes Clinical Trial Participation: A Diverse Group Interview StudyDeborah A Taira, Kauilaonālani Tengan, Julia Takata, et al.Therapeutic Innovation & Regulatory Science|June 6, 2020
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical TestingJoseph A DiMasi, Michael WilkinsonTherapeutic Innovation & Regulatory Science|November 18, 2022
Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case StudiesScott W Roberts, Tara Laura Brandt Elvang, Laila Syed, et al.Therapeutic Innovation & Regulatory Science|February 25, 2017
Culture and Process Change as a Priority for Patient Engagement in Medicines DevelopmentMarc Boutin, Lode Dewulf, Anton Hoos, et al.Pageof 165