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Clinical and Translational Science|August 21, 2024
Predicting progression-free survival from measurable residual disease in chronic lymphocytic leukemiaFlorencia A Tettamanti, Holly Kimko, Shringi Sharma, et al.
Clinical and Translational Science|August 8, 2024
Regulation of exosomes as biologic medicines: Regulatory challenges faced in exosome development and manufacturing processesChun-Kai Wang, Teng-Huang Tsai, Chung-Hsi Lee
Clinical and Translational Science|July 31, 2024
Pharmacokinetics, pharmacodynamics, and safety of asundexian in healthy Chinese and Japanese volunteers, and comparison with Caucasian dataHuijun Chen, Kensei Hashizume, Friederike Kanefendt, et al.
Clinical and Translational Science|August 2, 2024
Real-world evidence to support regulatory submissions: A landscape review and assessment of use casesGolnoosh Alipour-Haris, Xinyue Liu, Virginia Acha, et al.
Clinical and Translational Science|July 17, 2024
Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypesXiaojie Wu, Nanye Chen, Peiwen Hsu, et al.
Clinical and Translational Science|July 29, 2024
Assessing the net financial benefits of employing digital endpoints in clinical trialsJoseph A DiMasi, Abigail Dirks, Zachary Smith, et al.
Clinical and Translational Science|July 2, 2024
Integration of individual preclinical and clinical anti-infective PKPD data to predict clinical study outcomesVincent Aranzana-Climent, Wisse van Os, Amir Nutman, et al.
Clinical and Translational Science|July 1, 2024
Age-related off-label drug prescribing in pediatric patients in South Korea and consistency of labeling compared to the United States, Europe, and JapanBojung Park, Hyesung Lee, Hyeyoung Choi, et al.
Clinical and Translational Science|July 11, 2024
Dalzanemdor (SAGE-718), a novel, investigational N-methyl-D-aspartate receptor positive allosteric modulator: Safety, tolerability, and clinical pharmacology in randomized dose-finding studies in healthy participants and an open-label study in participants with Huntington's diseaseAaron Koenig, Michael Lewis, Jeff Wald, et al.
Clinical and Translational Science|July 8, 2024
A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participantsShichang Miao, Peter Staehr, Ezra Tai, et al.
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