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Therapeutic Innovation & Regulatory Science|February 11, 2021
Time to Revisit a Voluntary FDA Comparative Effectiveness PathwayBrian J Miller, Vrushab Gowda, Jodi B Segal
Therapeutic Innovation & Regulatory Science|February 16, 2021
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder SurveySamantha Cruz Rivera, Barbara Torlinska, Eliot Marston, et al.
Therapeutic Innovation & Regulatory Science|February 17, 2021
Quality and Authenticity of Metformin Tablets Circulating on Japanese WebsitesShu Zhu, Naoko Yoshida, Hirohito Tsuboi, et al.
Therapeutic Innovation & Regulatory Science|February 4, 2021
How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion ForumJens Rengelshausen, Kerstin Breithaupt-Groegler, Frank Donath, et al.
Therapeutic Innovation & Regulatory Science|August 9, 2019
How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient OrganizationsMarianne Botoft Hansen, Lotte Stig Nørgaard, Christine Erikstrup Hallgreen
Therapeutic Innovation & Regulatory Science|April 25, 2025
Incorporating Patient Input into the Target Product ProfileJean-Noel Talabardon, Janet E Church, Masanori Okuse, et al.
Therapeutic Innovation & Regulatory Science|April 19, 2025
Navigating the Evolving Eurasian Economic Union's Pharmaceutical Landscape: Streamlining Drug Registration for Market AccessC P Keerthana, Sanjay Sharma
Therapeutic Innovation & Regulatory Science|May 4, 2025
Has FDA's Drug Development Tools Qualification Program Improved Drug Development?Felix Yang, Imein Bousnina, Anne Madej, et al.
Therapeutic Innovation & Regulatory Science|May 29, 2025
The Adoption and Use of Artificial Intelligence and Machine Learning in Clinical DevelopmentMary Jo Lamberti, Maria I Florez, Hana Do, et al.
Therapeutic Innovation & Regulatory Science|May 27, 2025
Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand FrameworkYong Ma, Jonathan Haddad, Wei Liu, et al.
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