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Yuching Yang

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Articles 45
Citations 856
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Recent Articles
1.
Liu J, Yang Y, Gobburu J, Musante C, Klein M, Zhao L, et al.
Pharm Res . 2025 Mar; PMID: 40038161
Model-informed drug development (MIDD) approaches have become indispensable for new drug development and to address regulatory challenges. Dynamic tools, such as population pharmacokinetics (popPK), physiologically-based pharmacokinetics (PBPK), and quantitative systems...
2.
Singh S, Bradford D, Chatterjee S, Li X, Aungst S, Skinner A, et al.
Clin Cancer Res . 2025 Jan; PMID: 39808502
On April 23, 2024, FDA granted accelerated approval to tovorafenib, a type II RAF kinase inhibitor, for the treatment of patients 6 months of age and older with relapsed or...
3.
Bai J, Liu G, Zhao M, Wang J, Xiong Y, Truong T, et al.
CPT Pharmacometrics Syst Pharmacol . 2024 Oct; 13(12):2102-2110. PMID: 39423143
The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has continued to increase over the past decade. This report summarizes the landscape of QSP...
4.
Fusco M, Casak S, Mushti S, Cheng J, Christmas B, Thompson M, et al.
Clin Cancer Res . 2024 May; 30(15):3100-3104. PMID: 38809262
On November 8, 2023, the FDA approved fruquintinib, an inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, for the treatment of patients with metastatic colorectal cancer (mCRC)...
5.
Pan X, Wang L, Liu J, Earp J, Yang Y, Yu J, et al.
J Clin Pharmacol . 2023 Nov; 63 Suppl 2:S65-S77. PMID: 37942906
Obesity, which is defined as having a body mass index of 30 kg/m or greater, has been recognized as a serious health problem that increases the risk of many comorbidities...
6.
Telaraja D, Kasamon Y, Collazo J, Leong R, Wang K, Li P, et al.
Clin Cancer Res . 2023 Aug; 30(1):17-22. PMID: 37624619
In January 2023, the FDA granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of...
7.
Shoyaib A, Emami Riedmaier A, Kumar A, Roy P, Parrott N, Fang L, et al.
CPT Pharmacometrics Syst Pharmacol . 2023 Jan; 12(5):610-618. PMID: 36597353
This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day...
8.
Suzuki M, Jeng L, Chefo S, Wang Y, Price D, Li X, et al.
Genet Med . 2022 Dec; 25(2):100335. PMID: 36507973
The U.S. Food and Drug Administration recently approved lonafarnib as the first treatment for Hutchinson-Gilford progeria syndrome (HGPS) and processing-deficient progeroid laminopathies. This approval was primarily based on a comparison...
9.
Patel T, Marcus L, Horiba M, Donoghue M, Chatterjee S, Mishra-Kalyani P, et al.
Clin Cancer Res . 2022 Oct; 29(5):838-842. PMID: 36206041
On April 17, 2020, the FDA granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an...
10.
Duke E, Stapleford L, Drezner N, Amatya A, Mishra-Kalyani P, Shen Y, et al.
Clin Cancer Res . 2022 Sep; 29(3):508-512. PMID: 36112541
On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung...