Zobrazeno 1 - 10
of 23
pro vyhledávání: '"Mirat Shah"'
Autor:
Wei Gao, Jiang Liu, Blerta Shtylla, Karthik Venkatakrishnan, Donghua Yin, Mirat Shah, Timothy Nicholas, Yanguang Cao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 5, Pp 691-709 (2024)
Abstract Project Optimus is a US Food and Drug Administration Oncology Center of Excellence initiative aimed at reforming the dose selection and optimization paradigm in oncology drug development. This project seeks to bring together pharmaceutical c
Externí odkaz:
https://doaj.org/article/7b00914db39149309f99129a086a6b8b
Autor:
Harsh Oza, Victoria Grabinski, Hector Ibanez, Ines Godet, Daniele Gilkes, Ashley Cimino-Mathews, Edward Gabrielson, Mirat Shah, W. Iris Zhi, Zoe Pipa, Jennifer Lehman, Suqi Ke, Hua-Ling Tsai, Vered Stearns, Cesar Augusto Santa-Maria
Publikováno v:
Cancer Research. 83:P2-20
Title: Relationship of HIF-1α and tumor infiltrating lymphocytes in patients with HER2-negative early-stage breast cancer treated with neoadjuvant chemotherapy Authors: Grabinski VF, Oza HH, Gilkes DM, Shah MY, Cimino-Mathews A, Gabrielson E, Zhi I,
Autor:
Olga Marchenko, Rajeshwari Sridhara, Qi Jiang, Elizabeth Barksdale, Yuki Ando, Dinesh De Alwis, Katie Brown, Laura Fernandes, Mark T. J. van Bussel, Qiuyi Choo, Michael Coory, Elizabeth Garrett-Mayer, Thomas Gwise, Lorenzo Hess, Rong Liu, Sumithra Mandrekar, Daniele Ouellet, José Pinheiro, Martin Posch, Nam Atiqur Rahman, Khadija Rerhou Rantell, Andrew Raven, Sarem Sarem, Suman Sen, Mirat Shah, Yuan Li Shen, Richard Simon, Marc Theoret, Ying Yuan, Richard Pazdur
Publikováno v:
Statistics in Biopharmaceutical Research. :1-7
Autor:
Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H. Fiero, Ankit Shah, Salaheldin S. Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K. Ricks, Rajan Pragani, Arulvathani Arudchandran, Paresma Patel, Shadia Zaman, Arpita Roy, Shyam Kalavar, Soma Ghosh, William F. Pierce, Nam Atiqur. Rahman, Shenghui Tang, Bronwyn D. Mixter, Paul G. Kluetz, Richard Pazdur, Laleh Amiri-Kordestani
Publikováno v:
Clinical Cancer Research.
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian
Autor:
Jeanne Fourie Zirkelbach, Mirat Shah, Jonathon Vallejo, Joyce Cheng, Amal Ayyoub, Jiang Liu, Rachel Hudson, Rajeshwari Sridhara, Gwynn Ison, Laleh Amiri-Kordestani, Shenghui Tang, Thomas Gwise, Atiqur Rahman, Richard Pazdur, Marc R. Theoret
Publikováno v:
Journal of Clinical Oncology. 40:3489-3500
This review highlights strategies to integrate dose optimization into premarketing drug development and discusses the underlying statistical principles. Poor dose optimization can have negative consequences for patients, most commonly because of toxi
Autor:
Mirat Shah, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, William F. Pierce, Abhilasha Nair, Jonathan Herz, Kim J. Robertson, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Publikováno v:
Clinical Cancer Research. 28:5249-5253
On July 26, 2021, the FDA granted approval to pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as a single agent for adjuvant treatment following surgery for patients with high-risk, early-stage triple-negat
Autor:
Elaine M. Walsh, Neha Mangini, John Fetting, Deborah Armstrong, Isaac S. Chan, Roisin M. Connolly, Katie Fiallos, Jennifer Lehman, Raquel Nunes, Dana Petry, Jeffrey Reynolds, Mirat Shah, Karen L Smith, Kala Visvanathan, Josh Lauring, Ben H Park, Vered Stearns, Antonio C. Wolff
Publikováno v:
Clinical Breast Cancer. 22:319-325
Poly-ADP ribose polymerase (PARP) inhibitors (PARPi) are active in patients with germline BRCA1/2 (gBRCA1/2)-mutated breast cancer, accounting for 5% to 10% of all breast cancers. Another 5% to 10% harbor somatic BRCA1/2 (sBRCA1/2) mutations or mutat
Autor:
Harpreet Singh, Laleh Amiri-Kordestani, Amy Barone, Richard Pazdur, Mirat Shah, Janice Kim, Suparna Wedam, Diana Bradford, Gautam U Mehta, Erin Larkins, Adnan A. Jaigirdar, Marc R. Theoret, Lee Pai-Scherf, Julia A. Beaver
Publikováno v:
Journal of Neuro-Oncology
Objective Contemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug Administration (FDA) related to nervous system tumors. To summarize FDA updates applicable to neuro-oncology pra
Autor:
Phyllis Dvora Corn, Dan Ariely, Ravi Varadhan, Anna Ferguson, B. Douglas Smith, Mirat Shah, Benjamin W. Corn, Vered Stearns, Thomas J. Smith
Publikováno v:
JCO Oncol Pract
PURPOSE: Hope is a modifiable entity that can be augmented. We evaluated the feasibility, acceptability, and efficacy of a short intervention to increase hopefulness in patients with advanced breast cancer and oncologists. METHODS: We enrolled eligib
Autor:
Wei Chen, Marc R. Theoret, Pengfei Song, Xiao Hong Chen, Shenghui Tang, Kirsten B. Goldberg, Yutao Gong, Mallorie H. Fiero, Tiffany K. Ricks, William F. Pierce, Richard Pazdur, Joyce Cheng, Jianghong Fan, Fang Li, Mirat Shah, Suparna Wedam, Jingyu Yu, Laleh Amiri-Kordestani, Julia A. Beaver, Huiming Xia, Xinyuan Zhang
Publikováno v:
Clinical Cancer Research. 27:1220-1226
On April 17, 2020, the FDA approved tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have rece