Zobrazeno 1 - 10
of 111
pro vyhledávání: '"Sandhya Girish"'
Autor:
Rita Humeniuk, Kavita Juneja, Shuguang Chen, Scott Ellis, Olena Anoshchenko, Deqing Xiao, Aaron Share, Matthew Johnston, Santosh Davies, Adam DeZure, Joe Llewellyn, Anu Osinusi, Helen Winter, Sandhya Girish, Ramesh Palaparthy, Mark Dresser
Publikováno v:
Clinical and Translational Science, Vol 16, Iss 11, Pp 2276-2288 (2023)
Abstract Intravenous remdesivir (RDV) is US Food and Drug Administration–approved for hospitalized and nonhospitalized individuals with coronavirus disease 2019. RDV undergoes intracellular metabolic activation to form the active triphosphate, GS
Externí odkaz:
https://doaj.org/article/ab437c86ec334aa9a0a440c7bdc247ab
Autor:
Ting Chen, Ana Ruiz, Molly Zhao, Naveen Mangal, Matthew L Zierhut, Han Witjes, Thao Dang, Sandhya Girish, Sreeneeranj Kasichayanula
Publikováno v:
Journal for ImmunoTherapy of Cancer, Vol 11, Iss Suppl 1 (2023)
Externí odkaz:
https://doaj.org/article/647ec29f0caf4770b77124dccac1872a
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 10, Pp 2293-2302 (2022)
Abstract Pharmaceutical products in the current accelerated drug development landscape can benefit from tools beyond data generated from randomized control trials. We have seen an abundance of real‐world data (RWD) and real‐world evidence, driven
Externí odkaz:
https://doaj.org/article/e6f14b5c18904e94a95e622c45550f5c
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 8, Pp 1818-1837 (2022)
Abstract Cancer immunotherapy has significantly advanced the treatment paradigm in oncology, with approvals of immuno‐oncology agents for over 16 indications, many of them first line. Checkpoint inhibitors (CPIs) are recognized as an essential back
Externí odkaz:
https://doaj.org/article/e322787f3a6a42109ffe1625db83470c
Autor:
Benjamin Wu, Nitzan Sternheim, Priya Agarwal, Julia Suchomel, Shweta Vadhavkar, Rene Bruno, Marcus Ballinger, Coen A. Bernaards, Phyllis Chan, Jane Ruppel, Jin Jin, Sandhya Girish, Amita Joshi, Valerie Quarmby
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 1, Pp 130-140 (2022)
Abstract Baseline patient characteristics and prognostic factors are important considerations in oncology when evaluating the impact of immunogenicity on pharmacokinetics (PK) and efficacy. Here, we assessed the impact of anti‐drug antibodies (ADA)
Externí odkaz:
https://doaj.org/article/5e1e06bc19ff493482ec25b2f5e80c9f
Autor:
Cristina Julian, Robson J. M. Machado, Sandhya Girish, Pascal Chanu, Dominik Heinzmann, Chris Harbron, Anda Gershon, Shannon M. Pfeiffer, Wei Zou, Valerie Quarmby, Qing Zhang, Yachi Chen
Publikováno v:
Cancer Reports, Vol 5, Iss 10, Pp n/a-n/a (2022)
Abstract Background and aim The objective of this retrospective, observational, noninterventional cohort study was to investigate prognostic factors of overall survival (OS) in patients with advanced non‐small cell lung cancer (aNSCLC) and to devel
Externí odkaz:
https://doaj.org/article/1d3c8efe775a4a03ae0273cda40bf20a
Autor:
Tong Zhu, Makoto Kayama, Sandhya Girish, Vikram Sinha, Akintunde Bello, Atsuhiro Kawaguchi, Richard Czerniak, Lee Nagao
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 1, Pp 102-105 (2021)
The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Clinical Pharmacology Leadership Group (CPLG) held its first meeting of Japan‐based representatives at Astellas Pharma headquarters in Tokyo on October 1, 20
Externí odkaz:
https://doaj.org/article/b5d6dd1914364d1fbe41af5b10015f6e
Autor:
Dan Lu, Tong Lu, Leonid Gibiansky, Xiaobin Li, Chunze Li, Priya Agarwal, Colby S. Shemesh, Rong Shi, Randall C. Dere, Jamie Hirata, Dale Miles, Pascal Chanu, Sandhya Girish, Jin Yan Jin
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 1, Pp 48-59 (2020)
A two‐analyte integrated population pharmacokinetic (PK) model that simultaneously describes concentrations of antibody‐conjugated monomethyl auristatin E (acMMAE) and unconjugated MMAE following repeated administrations of polatuzumab vedotin (p
Externí odkaz:
https://doaj.org/article/2e23928c346b428697e782202249dc0d
Autor:
Colby S. Shemesh, Pascal Chanu, Kris Jamsen, Russ Wada, Gianluca Rossato, Francis Donaldson, Amit Garg, Helen Winter, Jane Ruppel, Xin Wang, Rene Bruno, Jin Jin, Sandhya Girish
Publikováno v:
Journal for ImmunoTherapy of Cancer, Vol 7, Iss 1, Pp 1-13 (2019)
Abstract Background The iMATRIX-atezolizumab study was a phase I/II, multicenter, open-label study designed to assess the safety and pharmacokinetics of atezolizumab in pediatric and young adult patients. We describe the pharmacokinetics (PK), exposu
Externí odkaz:
https://doaj.org/article/b996c2b9893a413b9905987d3a8dc5c2
Autor:
Chunze Li, Cindy Zhang, Rong Deng, Douglas Leipold, Dongwei Li, Brandon Latifi, Yuying Gao, Crystal Zhang, Zao Li, Dale Miles, Shang‐Chiung Chen, Divya Samineni, Bei Wang, Priya Agarwal, Dan Lu, Saileta Prabhu, Sandhya Girish, Amrita V. Kamath
Publikováno v:
Clinical and Translational Science, Vol 12, Iss 5, Pp 534-544 (2019)
Prediction of human pharmacokinetics (PK) based on preclinical information for antibody–drug conjugates (ADCs) provide important insight into first‐in‐human (FIH) study design. This retrospective analysis was conducted to identify an appropriat
Externí odkaz:
https://doaj.org/article/093a7f985ba448568183151dc8157a3a