Zobrazeno 1 - 10
of 104
pro vyhledávání: '"Ronald R Bowsher"'
Autor:
Marilyn Patterson, Lee Anne Beausang, Bonita Rup, Ronald R. Bowsher, Kim Krug, Murad Melhem, Sharon Lu
Publikováno v:
AAPS Open, Vol 7, Iss 1, Pp 1-16 (2021)
Abstract Dostarlimab (JEMPERLI) is a humanized anti-programmed death 1 (PD-1) immunoglobulin (Ig)G4-kappa monoclonal antibody that binds to the PD-1 receptor and competitively inhibits binding of its ligands, PD-L1 and PD-L2. Dostarlimab was recently
Externí odkaz:
https://doaj.org/article/70ba25086cdd4d4b9702c4e73dd8a05e
Autor:
Derrick Johnson, Erica Simmons, Sanofar Abdeen, Adam Kinne, Elijah Parmer, Sherri Rinker, Jennifer Thystrup, Swarna Ramaswamy, Ronald R. Bowsher
Publikováno v:
Scientific Reports, Vol 11, Iss 1, Pp 1-12 (2021)
Abstract Today the evaluation of unwanted immunogenicity is a key component in the clinical safety evaluation of new biotherapeutic drugs and macromolecular delivery strategies. However, the evolving structural complexity in contemporary biotherapeut
Externí odkaz:
https://doaj.org/article/96c6f914c2334dada702d38fc68654fe
Autor:
Bin Sun, Nilanjan Sengupta, Anita Rao, Charles Donnelly, Vinit Waichale, Arnab Sinha Roy, Shilpa Ramaswamy, Divya Pathak, Ronald R. Bowsher, Yaron Raiter, Patrick Aubonnet, Abhijit Barve
Publikováno v:
BMC Endocrine Disorders, Vol 21, Iss 1, Pp 1-10 (2021)
Abstract Background MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin g
Externí odkaz:
https://doaj.org/article/0bf18c5df35148c4bf95a40d112ace9c
Autor:
Conor J. Gallagher, Ronald R. Bowsher, Amanda Clancy, Jeffrey S. Dover, Shannon Humphrey, Yan Liu, Gregg Prawdzik
Publikováno v:
Toxins, Vol 15, Iss 1, p 60 (2023)
DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two placebo-con
Externí odkaz:
https://doaj.org/article/e0722c1b95914de6967e1bb40c7a805f
Autor:
Shannon Humphrey, Jeffrey S Dover, Ronald R Bowsher, Amanda Clancy, Yan Liu, Gregg Prawdzik, Conor J Gallagher
Publikováno v:
Aesthetic Surgery Journal.
DaxibotulinumtoxinA-lanm for injection (DAXI), a novel botulinum toxin type A formulation, contains a purified 150-kD core neurotoxin (daxibotulinumtoxinA) and proprietary stabilizing peptide (RTP004), and is approved for glabellar line treatment. As
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0c56f2151f11e72eab382e191f62ab95
https://doi.org/10.1093/asj/sjad101
https://doi.org/10.1093/asj/sjad101
Autor:
Adam S. Kinne, Erik J. Tillman, Sanofar J. Abdeen, Derrick E. Johnson, Elijah S. Parmer, Jacob P. Hurst, Brittany de Temple, Sherri Rinker, Timothy P. Rolph, Ronald R. Bowsher
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 232:115402
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5205fa2b9bda41eabd25acfeab510cf0
https://doi.org/10.1016/j.jpba.2023.115402
https://doi.org/10.1016/j.jpba.2023.115402
Autor:
Jessica A Feauto, Aleks Davis, Richard C Delhaye, Sanofar J Abdeen, Hannah N Gill, Jamie E Colwell, Michael Chiappetta, Emma E Clor, Ronald R Bowsher
Publikováno v:
Bioanalysis. 14(12)
High-quality critical reagents are essential for the establishment of robust ligand binding assays to support regulated bioanalysis. To ensure consistency in assay performance over the lifetime of a project, a well-defined set of processes is needed
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6adbe9734f709c428030633d9b77e91e
https://pubmed.ncbi.nlm.nih.gov/35904158
https://pubmed.ncbi.nlm.nih.gov/35904158
Autor:
Jim McNally, Szilárd Kamondi, Daniel Kramer, Honglue Shen, Vibha Jawa, Jane Ruppel, Charles S Hottenstein, Kelli R. Phillips, Meina Liang, Michael E Hodsdon, Dong Geng, Joanne Goodman, Mohsen Rajabi Ahbari, Heather Myler, Marta Starcevic Manning, Alvydas Mikulskis, William Hallett, Haoheng Yan, Adrienne Clements-Egan, Paul Chamberlain, Qiang Qu, ZhenZhen Liu, Carol Gleason, Viswanath Devanaryan, George R Gunn, Susan M. Richards, Theresa J Goletz, Troy E. Barger, Susana Liu, Lakshmi Amaravadi, Veerle Snoeck, Joao Pedras-Vasconcelos, Kathryn Lindley, Robert Nelson, Mark Ware, Shobha Purushothama, An Song, Susan Kirshner, Brian M Janelsins, Jad Zoghbi, Steven Bowen, Ronald R. Bowsher
Publikováno v:
The AAPS Journal. 24
Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. Followin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6bacf181ab0fa77b1607ce8395bb2e0
https://doi.org/10.1208/s12248-021-00649-y
https://doi.org/10.1208/s12248-021-00649-y
Autor:
Shannon Humphrey, Jeffrey S. Dover, Ronald R. Bowsher, Amanda Clancy, Yan Liu, Conor J. Gallagher
Publikováno v:
Toxicon. 214:S25-S26
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a3f9f964971ee0d30c783b6741ae4519
https://doi.org/10.1016/j.toxicon.2021.11.063
https://doi.org/10.1016/j.toxicon.2021.11.063
Publikováno v:
Journal of the American Academy of Dermatology. 87:AB32
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::57dacced4573b48f60f4f9a8b0d76d68
https://doi.org/10.1016/j.jaad.2022.06.161
https://doi.org/10.1016/j.jaad.2022.06.161