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Therapeutic Innovation & Regulatory Science|May 3, 2022
Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory TrialsWeidong Zhang, Sunhee Ro, Qi Jiang, et al.Therapeutic Innovation & Regulatory Science|July 27, 2022
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)Lerato Moeti, Madira Litedu, Jacques JoubertTherapeutic Innovation & Regulatory Science|July 25, 2022
A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United StatesYuko Hoshino, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|December 4, 2015
Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological ProductsEdward Dennis Bashaw, Doanh C Tran, Chinmay G Shukla, et al.Therapeutic Innovation & Regulatory Science|July 9, 2016
Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training EfficiencyJaime Arango, Tina Chuck, Susan S Ellenberg, et al.Therapeutic Innovation & Regulatory Science|November 6, 2015
Partnering With Patients in the Development and Lifecycle of Medicines: A Call for ActionAnton Hoos, James Anderson, Marc Boutin, et al.Therapeutic Innovation & Regulatory Science|May 4, 2018
Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMAHideyuki Kondo, Masayoshi Shibatsuji, Naoyuki YasudaTherapeutic Innovation & Regulatory Science|May 4, 2018
Improving Expanded Access in the United States: The Role of the Institutional Review BoardKelly McBride Folkers, Alison Bateman-HouseTherapeutic Innovation & Regulatory Science|May 8, 2018
Influence of Expedited Programs in the United States on Oncology Drug Development in JapanMakoto Tanaka, Naoki Matsumaru, Katsura TsukamotoTherapeutic Innovation & Regulatory Science|May 15, 2018
Biomaterials Evaluation: Conceptual Refinements and Practical ReformsReza Masaeli, Kavosh Zandsalimi, Lobat TayebiPageof 165