Zobrazeno 1 - 10
of 29
pro vyhledávání: '"Diana Montgomery"'
Autor:
Randolph P. Matthews, Rebecca E Wrishko, Mary Beth Dorr, Diana Montgomery, Lori M. Tobias, Ka Lai Yee
Publikováno v:
Clinical Pharmacology in Drug Development. 9:330-340
Bezlotoxumab is a fully human monoclonal antibody that binds and neutralizes Clostridium difficile toxin B. This analysis investigated the potential of bezlotoxumab to induce immunogenicity in healthy phase 1 trial participants and in phase 2/3 trial
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c143955e335b90abd36512af387fc90
https://doi.org/10.1002/cpdd.729
https://doi.org/10.1002/cpdd.729
Publikováno v:
Journal of pharmaceutical sciences. 111(4)
Immunogenicity to biologics is often observed following dosing in human subjects during clinical trials. Both product and host specific factors may be implicated in contributing to a potential immune response. However, even if such risk factors are i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3689a930fa23949e121b0691594f3af4
https://pubmed.ncbi.nlm.nih.gov/35122828
https://pubmed.ncbi.nlm.nih.gov/35122828
Autor:
Hang Su, Zhiqiang An, Ningyan Zhang, Leike Li, Dai Wang, Weifeng Xu, Diana Montgomery, Wei Xiong, Xinli Liu, Peng Gao, Amy S. Espeseth, Xiaohua Ye, Tong-Ming Fu, Ningning Ma, Daniel C. Freed, Zhiqiang Ku
Publikováno v:
Antimicrobial Agents and Chemotherapy
Human cytomegalovirus (HCMV) is a ubiquitous pathogen that can cause developmental disorders following congenital infection and life-threatening complications among transplant patients. Potent neutralizing monoclonal antibodies (MAbs) are promising d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b3625dddaa506e1b810644a29fc7fd28
https://doi.org/10.1128/aac.02422-20
https://doi.org/10.1128/aac.02422-20
Autor:
Allen Hunt, Diana Montgomery, Radha Railkar, Kalpit A. Vora, Luzelena Caro, Eseng Lai, Brad Roadcap, S. Aubrey Stoch, Dennis Wolford, Antonios O. Aliprantis, Kara S. Cox, Hua Ma, Laura M. Sterling, Brian M. Maas, Andrew W. Lee
Publikováno v:
Clinical pharmacology in drug developmentReferences. 10(5)
Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infection and related morbidity and mortality in infants. Passive immunization with an RSV-neutralizing antibody can provide rapid protection to this vulnerable p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::450aa1d64375f1beeae3722ffe8f3aa3
https://pubmed.ncbi.nlm.nih.gov/33125189
https://pubmed.ncbi.nlm.nih.gov/33125189
Autor:
Farah Al Qaraghuli, Ravindra Varma Alluri, Sophie M.A. Argon, Piyush Bajaj, Tashinga E. Bapiro, Abdul Basit, Andreas Brink, Tingting Cai, Jose Castro-Perez, Jae H. Chang, Eugene Chia-Te Chen, Marie Croft, Liam Evans, Raymond Evers, Robert S. Foti, Adrian J. Fretland, Christopher Gemski, Anima Ghosal, Jia Hao, Satyajeet Haridas, Simon Hauri, Nina Isoherranen, Wenying Jian, Kevin Johnson, Barry Jones, Robert S. Jones, Jan Felix Joseph, S. Cyrus Khojasteh, Yurong Lai, Hoa Le, Xiaomin Liang, Liming Liu, Filipe Lopes, Justin Q. Ly, Shuguang Ma, Roshini Markandu, Rosalinde Masereeuw, J. Eric McDuffie, Kaushik Mitra, Diana Montgomery, Alexandra L. Orton, Katie H. Owens, Axel Pähler, Maria Kristina Parr, Shefali Patel, Ichiko D. Petrie, Richard Phipps, Chandra Prakash, Bhagwat Prasad, Isabelle Ragueneau-Majlessi, Venkatesh Pilla Reddy, Ellen Riddle, Qian Ruan, Simone Schadt, Dhaval K. Shah, Julia Shanu-Wilson, Kelly MacLennan Staiger, Jonathan Steele, Manthena V.S. Varma, Matthew P. Wagoner, Naidong Weng, Stephen Wrigley, Caisheng Wu, Graeme C. Young, Jingjing Yu, Lushan Yu, Su Zeng, Haeyoung Zhang, Wanying Zhang, Andy Z.X. Zhu, Mingshe Zhu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::32563bc881f8145ec2036a1b650e62de
https://doi.org/10.1016/b978-0-12-820018-6.09990-7
https://doi.org/10.1016/b978-0-12-820018-6.09990-7
Publikováno v:
Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters ISBN: 9780128200186
In addition to drug-drug interactions (DDI) between small molecule drugs, it is recognized that the potential for interactions between small molecules and therapeutic proteins (TP) and other new modalities also needs to be considered. Thus far, focus
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6d42692cb81e4ee635a3a87cf497f952
https://doi.org/10.1016/b978-0-12-820018-6.00013-2
https://doi.org/10.1016/b978-0-12-820018-6.00013-2
Autor:
Candice Bailey‐Smith, Inga Bodrug, Monika Martinho, Amy Cheng, Lally Mekokishvili, Marian Iwamoto, Diana Montgomery, Azher Hussain, Peter M. Shaw, Vanessa Levine, Sauzanne Khalilieh, Xiaoli S. Glasgow
Publikováno v:
British Journal of Clinical Pharmacology. 84:2292-2302
Aims Tildrakizumab, an interleukin (IL)-23 inhibitor, is indicated for the treatment of moderate to severe chronic plaque psoriasis. Although tildrakizumab is not metabolized by, and does not alter, cytochrome P450 (CYP) expression in vitro, clinical
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::09b599d9985ea6350f998650ccd3ca9c
https://doi.org/10.1111/bcp.13670
https://doi.org/10.1111/bcp.13670
Publikováno v:
The AAPS journal. 22(3)
This document highlights some relevant factors in the assessment of immunogenicity risk of fusion protein therapeutics. Our aim is to highlight specific risks associated with this type of molecule, while also aligning with general risk assessment fac
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b1a4aae58e475093e45fc33d576fb438
https://pubmed.ncbi.nlm.nih.gov/32246297
https://pubmed.ncbi.nlm.nih.gov/32246297
Publikováno v:
The AAPS journal. 22(3)
This article provides a theoretical case-study risk assessment report for a low-risk monoclonal antibody (mAb) therapeutic. In terms of risk, there are considerations around risks to safety, but also risks regarding effects on pharmacokinetics (PK),
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bd538cdfa997317a847d83996bb6c11d
https://pubmed.ncbi.nlm.nih.gov/32185565
https://pubmed.ncbi.nlm.nih.gov/32185565
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 108
Tildrakizumab (also known as MK-3222), is a high-affinity, humanized, immunoglobin G1κ monoclonal antibody targeting the p19 subunit of interleukin-23 recently approved for the treatment of moderate to severe plaque psoriasis in the US, Europe, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::555fc093859bc07ac25c7f3b07c5a34f
https://pubmed.ncbi.nlm.nih.gov/31536773
https://pubmed.ncbi.nlm.nih.gov/31536773