Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Ronald Niebecker"'
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology
Models were developed to characterize the relationship between afatinib exposure and diarrhea and rash/acne adverse event (AE) trajectories, and their predictive ability was assessed. Based on pooled data from seven phase II/III clinical studies incl
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a016b07cc0b5263799f1f6b1f47a3e5f
https://doi.org/10.1002/psp4.12384
https://doi.org/10.1002/psp4.12384
Publikováno v:
Journal of Pharmacokinetics and Pharmacodynamics
Knowledge of the uncertainty in model parameters is essential for decision-making in drug development. Contrarily to other aspects of nonlinear mixed effects models (NLMEM), scrutiny towards assumptions around parameter uncertainty is low, and no dia
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5cd8756e495a14f5516016c1898d00c2
https://doi.org/10.1007/s10928-016-9496-7
https://doi.org/10.1007/s10928-016-9496-7
Autor:
Ulrika S. H. Simonsson, Ronald Niebecker, Elke H. J. Krekels, Joakim Nyberg, Raymond Miller, Siv Jönsson, Mats O. Karlsson
Publikováno v:
British Journal of Clinical Pharmacology. 80:1374-1387
Aims This study characterized the population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism in the Hokusai-VTE phase 3 study. The impact of the protocol-specified 50% dose reductions applied t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ff7cf3508ba64f43b63c4bec0b456948
https://doi.org/10.1111/bcp.12727
https://doi.org/10.1111/bcp.12727
Autor:
Takako Shimizu, Ulrika S. H. Simonsson, Kristin E. Karlsson, Ronald Niebecker, Mats O. Karlsson, Raymond Miller, Elke H. J. Krekels, Christian T. Ruff, Siv Jönsson
INTRODUCTION:Edoxaban is a novel factor Xa inhibitor. This study characterizes the population pharmacokinetics of edoxaban in patients with non-valvular atrial fibrillation (NVAF) included in the phase III ENGAGE AF-TIMI 48 study, evaluates covariate
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::86dde6fecf4014cfb544794afa5eea84
http://hdl.handle.net/1887/3199467
http://hdl.handle.net/1887/3199467
Autor:
Charles A. Peloquin, Alexander S. Pym, Mats O. Karlsson, Stefanie Hennig, Keith Gallicano, P. Bernard Fourie, Marc H Weiner, Ronald Niebecker, Peter Vis, Piero Olliaro, Helen McIlleron, Charles Flexner, Elin M. Svensson, Stefano Bonora
Publikováno v:
Journal of Antimicrobial Chemotherapy, 71, 1330-40
Journal of Antimicrobial Chemotherapy, 71, 5, pp. 1330-40
Journal of Antimicrobial Chemotherapy, 71, 5, pp. 1330-40
Item does not contain fulltext OBJECTIVES: Extensive but fragmented data from existing studies were used to describe the drug-drug interaction between rifabutin and HIV PIs and predict doses achieving recommended therapeutic exposure for rifabutin in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b557ac777920f704514cf2402dfb72d7
http://hdl.handle.net/2066/169464
http://hdl.handle.net/2066/169464
Autor:
Charlotte Kloft, Ronald Niebecker
Publikováno v:
Current Drug Safety. 5:275-286
Therapeutic monoclonal antibodies (mAbs) including antibody fusion proteins and antibody conjugates present an innovative class of (bio-)pharmaceuticals with increasing clinical importance. MAbs were initially perceived as comparatively safe drugs. A
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c8ef9bf108e14ac6b47d6575f1b76a59
https://doi.org/10.2174/157488610792246055
https://doi.org/10.2174/157488610792246055