Zobrazeno 1 - 10
of 13
pro vyhledávání: '"Mengdie Yuan"'
Publikováno v:
Jichu yixue yu linchuang, Vol 43, Iss 6, Pp 960-966 (2023)
Objective To explore the effect of copy number variation on the occurrence and development of hepatocellular carcinoma by using copy number variation and transcriptome experiment of hepatocellular carcinoma combined with public clinical data. Methods
Externí odkaz:
https://doaj.org/article/2a219529771f42f1a01dcf384eef9f72
Publikováno v:
Journal of Biopharmaceutical Statistics. 29:920-940
In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar. When there were multiple references, similarity among the reference products is also requir
Autor:
Lisa Rodriguez, Martha Donoghue, Soma Ghosh, Marc R. Theoret, Pamela S. Gallagher, Steven Lemery, Richard Pazdur, Julia A. Beaver, Lola Fashoyin-Aje, Mengdie Yuan, Leigh Marcus, Reena Philip
Publikováno v:
Clin Cancer Res
The FDA approved pembrolizumab on June 16, 2020, for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high [TMB-H; ≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approve
Autor:
Kirsten B. Goldberg, Steven Lemery, Lisa Rodriguez, Lorraine Pelosof, Richard Pazdur, Meredith K. Chuk, May Tun Saung, Marc R. Theoret, Mengdie Yuan, Sandra Casak, Peter Schotland, Lola Fashoyin-Aje, Gina Davis, Martha Donoghue
Publikováno v:
Oncologist
On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab in combination with ipilimumab for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib. The recommend
Publikováno v:
Statistics in Medicine. 36:2978-2993
As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovat
Publikováno v:
Proceedings of the 2017 2nd International Conference on Civil, Transportation and Environmental Engineering (ICCTE 2017).
Autor:
Mengdie Yuan1, Guoqing Diao1 gdiao@gmu.edu
Publikováno v:
BMC Proceedings. 2011 Supplement 9, Vol. 5 Issue Suppl 9, p1-4. 4p. 3 Charts, 1 Graph.
Publikováno v:
Journal of Biopharmaceutical Statistics. 23:98-109
Paired and multiple-to-one matched data have often been collected in clinical trials and epidemiological safety studies. When the response is binary, the sample size and power are determined by the discordant pairs or matched sets. Fixed sample size
Publikováno v:
Statistics in medicine. 36(19)
As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovat
Autor:
Guoqing Diao, Mengdie Yuan
Publikováno v:
Wiley Interdisciplinary Reviews: Computational Statistics. 10:e1425