Zobrazeno 1 - 10
of 67
pro vyhledávání: '"Binodh DeSilva"'
Autor:
Carmen Fernández-Metzler, Brad Ackermann, Fabio Garofolo, Mark E. Arnold, Binodh DeSilva, Huidong Gu, Omar Laterza, Yan Mao, Mark Rose, Faye Vazvaei-Smith, Rick Steenwyk
Publikováno v:
The AAPS journalReferences. 24(3)
Decades of discussion and publication have gone into the guidance from the scientific community and the regulatory agencies on the use and validation of pharmacokinetic and toxicokinetic assays by chromatographic and ligand binding assays for the mea
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::015448148b5ac9809c95d61f2ee9397e
https://pubmed.ncbi.nlm.nih.gov/35534647
https://pubmed.ncbi.nlm.nih.gov/35534647
Autor:
Weifeng Xu, Robert Dodge, Michael Sank, Renuka Pillutla, Carol Gleason, Gerry Kolaitis, Binodh DeSilva, Stephen M. Carl, Jennifer Cummings, Marina Juhel
Publikováno v:
Journal of Immunological Methods. 462:34-41
Biological therapeutics are foreign antigens and can potentially induce immune response resulting in the formation of anti-drug antibodies (ADA), which in turn may lead to a wide range of side effects. Neutralizing Ab (NAb) is a subset of ADA that ca
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1ac9f2f5b3cb7be2a28b6b03bea47a4d
https://doi.org/10.1016/j.jim.2018.08.003
https://doi.org/10.1016/j.jim.2018.08.003
Autor:
Marina Juhel, Binodh DeSilva, Robert Dodge, Weifeng Xu, Xuefeng Li, Michael Sank, Jennifer Cummings, Renuka Pillutla, Carol Gleason
Publikováno v:
Bioanalysis. 10:1273-1287
Ipilimumab is the first US FDA-approved immune checkpoint-blocking antibody drug to harness the patient's own immune cells. One of the postmarketing requirements is to develop a cell-based neutralizing antibody assay. Here, we share some of the most
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::355fc04edcb9f42b6d6256768aee2e19
https://doi.org/10.4155/bio-2018-0109
https://doi.org/10.4155/bio-2018-0109
Autor:
Binodh DeSilva, Alexander T. Kozhich, Rong Liu, Jia Duo, Jon E. Peterson, Jonathan Haulenbeek, Donata David-brown, Lora Hamuro, Linlin Luo, Renuka Pillutla, Steven P. Piccoli, Rasa Santockyte, JoAnne Bruno, Yan J Zhang, Suk Kwok
Publikováno v:
Bioanalysis. 10:559-576
Ligand-binding assay (LBA) performance depends on quality reagents. Strategic reagent screening and characterization is critical to LBA development, optimization and validation. Application of advanced technologies expedites the reagent screening and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7606fddc05b14aaa8d001ee0ec82d4d5
https://doi.org/10.4155/bio-2017-0271
https://doi.org/10.4155/bio-2017-0271
Publikováno v:
Bioanalysis. 9:193-207
Aim: Ligand-binding assay (LBA) reagent labeling may change the binding characteristics of the reagent to its target and degrade its performance in LBAs. Results: A surface plasmon resonance (SPR) biosensor was used to evaluate the impact of the biot
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1e88bb9eab6c3ff1eccc14d51ab8102c
https://doi.org/10.4155/bio-2016-0204
https://doi.org/10.4155/bio-2016-0204
Autor:
Adrienne Clements-Egan, Binodh DeSilva, Viswanath Devanarayan, Boris Gorovits, George R. Gunn, Vinod P. Shah, Kelli R. Phillips, Susan Kirshner, Heather Myler
Publikováno v:
The AAPS Journal. 21
In September 2018, the American Association of Pharmaceutical Scientists (AAPS) conducted an Annual Guidance Forum on the considerations related to immunogenicity testing for therapeutic protein products. In addition to a broad representation by the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b09c5e535f432b4e29687662b3186436
https://doi.org/10.1208/s12248-019-0328-8
https://doi.org/10.1208/s12248-019-0328-8
Autor:
Giridhar S. Tirucherai, Sean M. Crawford, Binodh DeSilva, Renuka Pillutla, Akbar Nayeem, Lora Hamuro, Craig J. Thalhauser, Tarek A. Leil
Publikováno v:
The AAPS journal. 21(5)
A mechanistic model of the immune response was evaluated for its ability to predict anti-drug antibody (ADA) and their impact on pharmacokinetics (PK) and pharmacodynamics (PD) for a biotherapeutic in a phase 1 clinical trial. Observed ADA incidence
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c4a7025adccf7a28fb57fdbde5a73a9
https://pubmed.ncbi.nlm.nih.gov/31342199
https://pubmed.ncbi.nlm.nih.gov/31342199
Autor:
Daniel Tang, Hanns-Christian Mahler, Michiho Ito, Hitoshi Sasaki, Michael B. Ward, Binodh DeSilva, Don Mager, Anke H. Maitland-van der Zee, Takuya Kumamoto, Geoffrey T. Tucker, Jennifer B. Dressman, Vinod P. Shah, Giovanni M. Pauletti
Publikováno v:
Journal of pharmaceutical sciences, 105(9), 2489-2497. John Wiley and Sons Inc.
The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::369afbbf616e074f5eb4ee5ea666dc36
https://doi.org/10.1016/j.xphs.2015.12.001
https://doi.org/10.1016/j.xphs.2015.12.001
Autor:
Vangipuram S. Rangan, Amy Manney, Mark Saewert, Ang Liu, Binodh DeSilva, Donna Dail, Jennifer Cummings, Renuka Pillutla, Alex Kozhich, Heather Myler, Chetana Rao, Jian Wang, Brian K. Hoffpauir
Publikováno v:
Bioanalysis. 8:519-531
Background: The bioanalytical strategy for antibody–drug conjugates (ADC) includes multiple integrated measurements of pharmacologically relevant ADC. Methods & results: Three ligand-binding assays were validated for the measurement of total antibo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3681fec20a59b885ac063763e7b9d22b
https://doi.org/10.4155/bio.16.13
https://doi.org/10.4155/bio.16.13
Autor:
Snaehal Gadkari, Kristina D. Chadwick, Alicja Batog, Weifeng Xu, Renuka Pillutla, Jennifer Wheeler, Binodh DeSilva, Craig Titsch, Bonnie Wang, Heather Myler, Chris M. Thompson, James Stahl, Robert Dodge, Lauren Hippeli, Hao Jiang, Scott Willett, Brent Yamamoto
Publikováno v:
Bioanalysis. 10(16)
Aim: A ligand-binding assay (LBA) was used to measure exposure of PRM-151, the recombinant form of human pentraxin-2 (PTX-2), a complex pentamer with multiple binding partners. However, the assay showed a lack of dose-dependent exposure in select pre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4327a3253475fb0e034c3328db437bc2
https://pubmed.ncbi.nlm.nih.gov/29923414
https://pubmed.ncbi.nlm.nih.gov/29923414