Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Katharina Erb-Zohar"'
Autor:
Holger Zimmermann, Katharina Erb-Zohar, Dirk Kropeit, Helga Rübsamen-Schaeff, Jochen G W Theis, Hans-Peter Stobernack, Jürgen Scheuenpflug, David McCormick
Publikováno v:
Clinical Pharmacology in Drug Development. 11:6-15
Letermovir is a human cytomegalovirus (CMV) terminase inhibitor approved in the United States, Canada, Japan, and the European Union for prophylaxis of CMV infection and disease in CMV-seropositive, allogeneic, hematopoietic stem-cell transplant reci
Autor:
Hildegard Sourgens, Katharina Erb-Zohar, Gerd Mikus, Frank Donath, Kerstin Breithaupt-Groegler, Stephanie Plassmann, Jens Rengelshausen, Georg Wensing, Timothy C. Hardman
Publikováno v:
Therapeutic Innovation & Regulatory Science
Purpose A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator’s Brochure (IB) for meaningful risk assessment of early clinical trials. Materia
Publikováno v:
International Journal of Clinical Pharmacology and Therapeutics
Purpose To collect information on unintended drug exposure during pregnancy in early clinical drug development. Materials and methods Questionnaire mailed in autumn 2015 to members of human pharmacology societies in Europe for anonymous responses via
Publikováno v:
International Journal of Clinical Pharmacology and Therapeutics
Purpose To collect information on the use of integrated protocols in early clinical medicines development. Materials and methods The questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses vi
Autor:
Valentin S. Moiseev, David McCormick, Holger Zimmermann, Dirk Kropeit, Zhanna Kobalava, Katharina Erb-Zohar, Hans-Peter Stobernack, Helga Rübsamen-Schaeff
Publikováno v:
British Journal of Clinical Pharmacology. 83:2678-2686
Aims Human cytomegalovirus constitutes a prevalent and serious threat to immunocompromised individuals and requires new treatments. Letermovir is a novel viral-terminase inhibitor that has demonstrated prophylactic/pre-emptive activity against human
Autor:
Karin Goehler, Thomas Sudhop, Martin Coenen, Klaus Peter Kammerer, Klaus Francke, Georg Wensing, Hildegard Sourgens, Jens Rengelshausen, Frank Donath, Mario Iovino, Kerstin Breithaupt-Groegler, Reinhard Schinzel, Gerd Mikus, Christoph Coch, Katharina Erb-Zohar
Publikováno v:
European Journal of Clinical Pharmacology
Introduction/Methods A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolli
Autor:
Katharina Erb-Zohar, David McCormick, Helga Rübsamen-Schaeff, Holger Zimmermann, Hans-Peter Stobernack, Dirk Kropeit
Publikováno v:
Clinical pharmacology in drug developmentReferences. 11(1)
Letermovir is a human cytomegalovirus (CMV) terminase inhibitor for the prophylaxis of CMV infection and disease in allogeneic hematopoietic stem-cell transplant recipients. In vitro studies have identified letermovir as a potential cytochrome P450 (
Autor:
Egj Hulskotte, H-P Stobernack, Dirk Kropeit, Katharina Erb-Zohar, Holger Zimmermann, Helga Rübsamen-Schaeff, J Scheuenpflug, A van Schanke
Publikováno v:
Clinical and Translational Science
Letermovir is a novel antiviral in clinical development for prophylaxis against human cytomegalovirus in immunocompromised transplant recipients. This two‐part, single‐center, randomized, double‐blind, placebo‐controlled trial evaluated the s
Autor:
Dirk, Kropeit, Jürgen, Scheuenpflug, Katharina, Erb-Zohar, Atef, Halabi, Hans-Peter, Stobernack, Ellen G J, Hulskotte, Arne, van Schanke, Holger, Zimmermann, Helga, Rübsamen-Schaeff
Publikováno v:
British journal of clinical pharmacology. 83(9)
Human cytomegalovirus remains a significant issue for immunocompromised patients and existing viral polymerase targeting therapies are associated with significant toxicity. Accordingly, the viral terminase complex inhibitor, letermovir, is in develop