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Therapeutic Innovation & Regulatory Science|February 24, 2026
A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and OpportunitiesBianca C Claro, Erica F Condado, Livia D PradoTherapeutic Innovation & Regulatory Science|February 21, 2026
Innovative Multidimensional Quantitative Benefit-Risk Model for Effective Decision Making in Research and Development for Biopharmaceutical IndustryMaria E Verdugo, Fabio A Lievano, Melvin S Munsaka, et al.Therapeutic Innovation & Regulatory Science|March 9, 2026
Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy DataAjibade Ashaye, Caitlin Thomas, Vamsi Kota, et al.Therapeutic Innovation & Regulatory Science|February 7, 2024
Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality FrameworkMichael Torok, Leslie Sam, Jennifer HebertTherapeutic Innovation & Regulatory Science|March 26, 2024
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial DataKelly H Zou, Chelsea Vigna, Aniketh Talwai, et al.Therapeutic Innovation & Regulatory Science|March 26, 2024
New Benchmarks on Protocol Amendment Experience in Oncology Clinical TrialsEmily Botto, Zachary Smith, Kenneth GetzTherapeutic Innovation & Regulatory Science|February 17, 2024
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical TrialsAbigail Dirks, Maria Florez, Francois Torche, et al.Therapeutic Innovation & Regulatory Science|March 8, 2024
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and RecommendationsGaia Geraci, Robert Smith, Alison Hansford, et al.Therapeutic Innovation & Regulatory Science|August 10, 2023
Global Postmarket Pharmacovigilance: A Generic Drug PerspectiveTaylor Dalsey, Edward Kim, Howard Chazin, et al.Therapeutic Innovation & Regulatory Science|August 10, 2023
Landscape Analysis of Generic Availability for Oncologic DrugsVaibhav Kumar, Fenggong Wang, Meng Hu, et al.Pageof 165