Zobrazeno 1 - 10
of 48
pro vyhledávání: '"Andrej, Skerjanec"'
Autor:
Anca Boldea, Stefanie Schier-Mumzhiu, Anne Bellon, Ahad Sabet, Sven D. Koch, Celine Schelcher, Maria Velinova, Roumen Nakov, Sreekanth Gattu, Daniel Dickerson, Andrej Skerjanec, Charles Tomek, Steven Schussler, Jessie Wang, Terry O'Reilly, Ly Ngo, Gordon P. Otto, Miryana Dobreva
Publikováno v:
British Journal of Clinical Pharmacology
Aims Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1456530735daa455f7afd224ba47188f
http://europepmc.org/articles/PMC7256126
http://europepmc.org/articles/PMC7256126
Autor:
Julia Jauch-Lembach, Oliver von Richter, Andrej Skerjanec, Halimuniyazi Haliduola, Alison Balfour, Lena Lemke, Britta Zehnpfennig
Publikováno v:
Expert Opinion on Biological Therapy. 19:1057-1064
Introduction: Antidrug antibody (ADA) development is known to occur with adalimumab treatment and impacts adalimumab exposure. Here, we compare the impact of immunogenicity on pharmacokinetics (PK) across two randomized PK studies of GP2017, an appro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9dadda65493b3ef76a8220d7f8962419
https://doi.org/10.1080/14712598.2019.1603959
https://doi.org/10.1080/14712598.2019.1603959
Autor:
Oliver von Richter, Thomas Koernicke, Lena Lemke, Johann Poetzl, Julia Jauch-Lembach, Maria Velinova, Ellen Schuck, Halimuniyazi Haliduola, Andrej Skerjanec, Rainard Fuhr
Publikováno v:
Expert Opinion on Biological Therapy. 19:1075-1083
Background: To compare the pharmacokinetics of Sandoz biosimilar adalimumab (GP2017) with reference adalimumab (Humira) in healthy volunteers (PK similarity study) and to compare the pharmacokineti...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c07a4b19ed85fb54adcd7ab704440769
https://doi.org/10.1080/14712598.2019.1571580
https://doi.org/10.1080/14712598.2019.1571580
Autor:
Andrej Skerjanec, Roumen Nakov, Jessie Wang, Sreekanth Gattu, Gregor Schaffar, Maria Velinova
Publikováno v:
British Journal of Clinical Pharmacology. 84:2790-2801
Aims This study aimed to demonstrate that the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Sandoz proposed biosimilar pegfilgrastim (LA-EP2006) matches reference pegfilgrastim (Neulasta® ) in healthy subjects. Safety and immunogenicity w
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::bb9eac6072cb5dd694eb9d82c58d1474
https://doi.org/10.1111/bcp.13731
https://doi.org/10.1111/bcp.13731
Autor:
Michel Laviolette, Suzanne Maahs, Veronica A. Swystun, Louis-Philippe Boulet, Irvin Mayers, Christopher Carlsten, Philip J. Lowe, Barbro Dahlén, Andrej Skerjanec, Miranda Bowen, Richard Leigh, Linda Hui, Beth E. Davis, Richard M. Watson, Gail M. Gauvreau, Kieran J. Killian, Joanne Milot, Anton Drollmann, Paul M. O'Byrne, J. Mark FitzGerald, Ann-Sofie Lantz, Karin Meiser, Nikolaos Lazarinis, Jonathan P. Arm, Donald W. Cockcroft
Publikováno v:
Journal of Allergy and Clinical Immunology. 138:1051-1059
Background Omalizumab is an established anti-IgE therapy for the treatment of allergic diseases that prevents IgE from binding to its receptor. QGE031 is an investigational anti-IgE antibody that binds IgE with higher affinity than omalizumab. Object
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0499d7d9d17d565f4598483e0cda9c9b
https://doi.org/10.1016/j.jaci.2016.02.027
https://doi.org/10.1016/j.jaci.2016.02.027
Autor:
Roumen, Nakov, Sreekanth, Gattu, Jessie, Wang, Maria, Velinova, Gregor, Schaffar, Andrej, Skerjanec
Publikováno v:
British journal of clinical pharmacology. 84(12)
AIMS: This study aimed to demonstrate that the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Sandoz proposed biosimilar pegfilgrastim (LA‐EP2006) matches reference pegfilgrastim (Neulasta(®)) in healthy subjects. Safety and immunogenici
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::7474f25b7b1f361fb7415e6991e86751
https://pubmed.ncbi.nlm.nih.gov/30079636
https://pubmed.ncbi.nlm.nih.gov/30079636
Publikováno v:
The AAPS Journal. 20
This article provides an overview of four case studies to demonstrate the utility of pharmacometric analysis in biosimilar development to help design sensitive clinical pharmacology studies for the demonstration of biosimilarity. The two major factor
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ae48c023e54650047878e6d9a86ab927
https://doi.org/10.1208/s12248-018-0196-7
https://doi.org/10.1208/s12248-018-0196-7
Autor:
Peijuan Zhu, Andrej Skerjanec
Publikováno v:
Biosimilars ISBN: 9783319996790
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4729612c3bfeb0534beb8f8525ce06d0
https://doi.org/10.1007/978-3-319-99680-6_21
https://doi.org/10.1007/978-3-319-99680-6_21
Autor:
Peter Lloyd, Andrej Skerjanec, Sherri Dudal, A Cordier, Jennifer Sims, Stewart Jones, Sarah Taplin, Carsten Krantz, Aline Piequet, G Jarai, Frank R. Brennan, Thierry Flandre, Andrew Paul Warren, K Subramanian, M Duval, J-C Genin, WS Law, G Van Heeke, Philip J. Lowe
Publikováno v:
mAbs. 7:829-837
QBP359 is an IgG1 human monoclonal antibody that binds with high affinity to human CCL21, a chemokine hypothesized to play a role in inflammatory disease conditions through activation of resident CCR7-expressing fibroblasts/myofibroblasts. The pharma
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c15e2f7cb75d37828b9cacf97a7bcd18
https://doi.org/10.1080/19420862.2015.1060384
https://doi.org/10.1080/19420862.2015.1060384
Autor:
Ieuan Jones, Andrej Skerjanec, S. Maahs, Ivan Bottoli, Philip J. Lowe, David Floch, Jonathan P. Arm, C. E. Owen, Andrea Groenewegen
Publikováno v:
Clinical and Experimental Allergy
SummaryBackground Using a monoclonal antibody with greater affinity for IgE than omalizumab, we examined whether more complete suppression of IgE provided greater pharmacodynamic effects, including suppression of skin prick responses to allergen. Obj
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8dadc5eaee4de0a3fd26e72490b621c6
https://doi.org/10.1111/cea.12400
https://doi.org/10.1111/cea.12400