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A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects.

Autor: Jeon, Yoomin^1,2,3 (AUTHOR), Lee, Nora⁴ (AUTHOR), Baek, Seungjae⁴ (AUTHOR), Choi, JaeDuk⁴ (AUTHOR), Jhee, Stanford⁵ (AUTHOR), Lee, Howard^1,2,3,6,7 (AUTHOR) howardlee@snu.ac.kr

Publikováno v: Drugs in R&D. Mar2022, Vol. 22 Issue 1, p71-87. 17p.

Common data model-based real-world data for practical clinical practice guidelines: clinical pharmacology perspectives.

Autor: Jeon Y; Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea., Choi Y; Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea., Kim EH; Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea., Oh S; Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea., Lee H; Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Center for Convergence Approaches in Drug Development, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.; Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine, Seoul 03080, Korea.; Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul 08826, Korea.

Publikováno v: Translational and clinical pharmacology [Transl Clin Pharmacol] 2020 Jun; Vol. 28 (2), pp. 67-72. Date of Electronic Publication: 2020 Jun 25.