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Therapeutic Innovation & Regulatory Science|May 2, 2018
Strategic and Statistical Considerations on the QT Assessment of VolasertibGudrun Wallenstein, Beate Walter, Holger Fritsch, et al.
Therapeutic Innovation & Regulatory Science|May 2, 2018
Survey of Safety Information in the Investigator's Brochure: Inconsistencies and RecommendationsMichael Jacob Klepper, Leander Fontaine
Therapeutic Innovation & Regulatory Science|May 2, 2018
Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?Elizabeth Richardson, Gregory Daniel, David R Joy, et al.
Therapeutic Innovation & Regulatory Science|May 2, 2018
Evolution of Drug Development: Integrating the Patient Perspective Into Early ResearchAnthony J Yanni, Jennifer Fine
Therapeutic Innovation & Regulatory Science|May 2, 2018
Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television AdvertisementsGermin Fahim, Michael Toscani, Joseph A Barone, et al.
Therapeutic Innovation & Regulatory Science|May 2, 2018
Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for DiclofenacVivien Tong, David K Raynor, Parisa Aslani
Therapeutic Innovation & Regulatory Science|May 4, 2018
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint StudiesLewis J Fermaglich, Ru Chen, Carol Y Kim, et al.
Therapeutic Innovation & Regulatory Science|August 21, 2025
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical TrialsAbigail Dirks, Hana Do, Chelsea Gallagher, et al.
Therapeutic Innovation & Regulatory Science|August 21, 2025
Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety DevicesTuncay Bayrak
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