Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Elisabeth Husar"'
Autor:
Doha Naga, Smaragda Dimitrakopoulou, Sonia Roberts, Elisabeth Husar, Susanne Mohr, Helen Booler, Eunice Musvasva
Publikováno v:
Scientific Reports, Vol 13, Iss 1, Pp 1-16 (2023)
Abstract In-vivo toxicity assessment is an important step prior to clinical development and is still the main source of data for overall risk assessment of a new molecular entity (NCE). All in-vivo studies are performed according to regulatory requir
Externí odkaz:
https://doaj.org/article/29caf756a49742ddb010ee163c88d7a3
Autor:
Inja Waldhauer, Valeria Gonzalez-Nicolini, Anne Freimoser-Grundschober, Tapan K Nayak, Linda Fahrni, Ralf J. Hosse, Danny Gerrits, Edwin J. W. Geven, Johannes Sam, Sabine Lang, Esther Bommer, Virginie Steinhart, Elisabeth Husar, Sara Colombetti, Erwin Van Puijenbroek, Markus Neubauer, J. Mark Cline, Pradeep K. Garg, Gregory Dugan, Federica Cavallo, Gonzalo Acuna, Jehad Charo, Volker Teichgräber, Stefan Evers, Otto C. Boerman, Marina Bacac, Ekkehard Moessner, Pablo Umaña, Christian Klein
Publikováno v:
mAbs, Vol 13, Iss 1 (2021)
Simlukafusp alfa (FAP-IL2v, RO6874281/RG7461) is an immunocytokine comprising an antibody against fibroblast activation protein α (FAP) and an IL-2 variant with a retained affinity for IL-2Rβγ > IL-2 Rβγ and abolished binding to IL-2 Rα. Here,
Externí odkaz:
https://doaj.org/article/92299c28b9d34a45bf95cf39c2bbc494
Autor:
Doha Naga, Smaragda Dimitrakopoulou, Sonia Roberts, Elisabeth Husar, Susanne Mohr, Helen Booler, Eunice Musvasva
In-vivo toxicity assessment is an important step prior to clinical development and is still the main source of data for overall risk assessment of a new molecular entity (NCE). All in-vivo studies are performed according to regulatory requirements an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::aff8858ec323ce04a8a3997df28584a7
https://doi.org/10.1101/2022.08.06.503048
https://doi.org/10.1101/2022.08.06.503048
Autor:
Christian Klein, Wolfgang F. Richter, Dominik Hainzl, Eginhard Schick, Nicole Justies, Hans Peter Grimm, Elisabeth Husar, Li Yu
Publikováno v:
Journal of Pharmaceutical Sciences. 108:3729-3736
The pharmacokinetics (PK) of the anti-CD20 monoclonal antibody obinutuzumab was assessed after single intravenous dosing to cynomolgus monkeys. In addition, the pharmacokinetic-pharmacodynamic (PKPD) relationship for B-cell depletion was characterize
Autor:
Nicolas Frances, Marina Bacac, Katharine Bray-French, François Christen, Heather Hinton, Elisabeth Husar, Elizabeth Quackenbush, Martin Schäfer, Eginhard Schick, Arthur Van De Vyver, Wolfgang F. Richter
Publikováno v:
Journal of pharmaceutical sciences. 111(4)
We present a novel approach for first-in-human (FIH) dose selection of the CD20xCD3 bispecific antibody, glofitamab, based on pharmacokinetic/pharmacodynamic (PKPD) assessment in cynomolgus monkeys to select a high, safe starting dose, with cytokine
Autor:
Ralf Hosse, Federica Cavallo, Esther Bommer, Danny Gerrits, Valeria Gonzalez-Nicolini, Marina Bacac, Volker Teichgräber, Stefan Evers, Gregory O. Dugan, Tapan K. Nayak, Erwin van Puijenbroek, Inja Waldhauer, Elisabeth Husar, J. Mark Cline, Virginie Steinhart, Gonzalo Acuna, Ekkehard Moessner, Markus Neubauer, Johannes Sam, Edwin J. W. Geven, Pradeep Garg, Sabine Lang, Jehad Charo, Sara Colombetti, Christian Klein, Linda Fahrni, Anne Freimoser-Grundschober, Otto C. Boerman, Pablo Umana
Publikováno v:
mAbs
article-version (VoR) Version of Record
Mabs, 13
Mabs, 13, 1
article-version (VoR) Version of Record
Mabs, 13
Mabs, 13, 1
Simlukafusp alfa (FAP-IL2v, RO6874281/RG7461) is an immunocytokine comprising an antibody against fibroblast activation protein α (FAP) and an IL-2 variant with a retained affinity for IL-2Rβγ > IL-2 Rβγ and abolished binding to IL-2 Rα. Here,
Autor:
Hanna Piper-Lepoutre, Gaurav Tyagi, Eginhard Schick, Olaf Kuhlmann, Thomas Singer, Elisabeth Husar, Maria Solonets
Publikováno v:
Toxicologic Pathology. 45:676-686
Obinutuzumab (GA101, Gazyva™, Gazyvaro®, F. Hoffmann-La Roche AG, Basel, Switzerland) is a humanized, glycoengineered type II antibody targeted against CD20. The preclinical safety evaluation required to support clinical development and marketing
Autor:
Richard Peck, Elisabeth Husar, Robert Dannecker, Markus Abt, Christoph Wandel, Theo Dinklo, Lucette Doessegger, Katja Kallivroussis, Andreas Rothfuss
Publikováno v:
Clinical Pharmacology and Therapeutics
Traditionally, in dose-escalating first-in-human (FiH) studies, a dose cap with a 10-fold safety margin to the no observed effect level in animals is implemented if convulsive events are observed in animals. However, the convulsive risk seen in anima
Autor:
Christine Schubert, Sven Kronenberg, Franziska Regenass, Thomas Emrich, Anna Maria Giusti, Elisabeth Husar, Martin Lechmann, Christian Freichel
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 88
With the emergence of novel biotherapeutic formats and immunostimulatory biotherapeutics in cancer immunotherapy, an understanding of immune-complex (IC) mediated hypersensitivity reactions in toxicology studies - and their differentiation from pharm
Autor:
Lutz Müller, Elisabeth Husar
Publikováno v:
The Textbook of Pharmaceutical Medicine
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::166c649f5ce6d4a0e34bed4ffb5c70eb
https://doi.org/10.1002/9781118532331.ch3
https://doi.org/10.1002/9781118532331.ch3