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Andreas Günther
Researcher at Hoffmann-La Roche
Publications - 6
Citations - 153
Andreas Günther is an academic researcher from Hoffmann-La Roche. The author has contributed to research in topics: SMA* & Pharmacodynamics. The author has an hindex of 4, co-authored 6 publications receiving 75 citations.
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Journal ArticleDOI
A phase 1 healthy male volunteer single escalating dose study of the pharmacokinetics and pharmacodynamics of risdiplam (RG7916, RO7034067), a SMN2 splicing modifier.
Stefan Sturm,Andreas Günther,Birgit Jaber,Paul Jordan,Nada Al Kotbi,Nikhat Parkar,Yumi Cleary,Nicolas Frances,Tobias Bergauer,Katja Heinig,Heidemarie Kletzl,Anne Marquet,Hasane Ratni,Agnès Poirier,Lutz Müller,Christian Czech,Omar Khwaja +16 more
TL;DR: The objectives of this entry‐into‐human study were to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of risdiplam, and the effect of the strong CYP3A inhibitor itraconazole on the PK of ris diplam in healthy male volunteers.
Journal ArticleDOI
Ocrelizumab in relapsing and primary progressive multiple sclerosis: Pharmacokinetic and pharmacodynamic analyses of OPERA I, OPERA II and ORATORIO
Ekaterina Gibiansky,Claire Petry,Francois Mercier,Andreas Günther,Ann Herman,Ludwig Kappos,Stephen L. Hauser,Yumi Yamamoto,Qing Wang,Fabian Model,Heidemarie Kletzl +10 more
TL;DR: Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20‐positive B cells and is indicated for treatment of patients with relapsing forms of multiple sclerosis or primary progressive multiple sclerosis.
Journal ArticleDOI
The oral splicing modifier RG7800 increases full length survival of motor neuron 2 mRNA and survival of motor neuron protein: Results from trials in healthy adults and patients with spinal muscular atrophy
Heidemarie Kletzl,Anne Marquet,Andreas Günther,Wakana Tang,Jules A. A. C. Heuberger,Geert Jan Groeneveld,W. Birkhoff,Eugenio Mercuri,Hanns Lochmüller,Claire L Wood,Dirk Fischer,Irene Gerlach,Katja Heinig,Teodorica L. Bugawan,Sebastian Dziadek,Russell Kinch,Christian Czech,Omar Khwaja +17 more
TL;DR: In two trials, oral administration of RG7800 increased in blood full-length SMN2 mRNA expression in healthy adults and SMN protein levels in SMA patients by up to two-fold, which is expected to provide clinical benefit.
Journal ArticleDOI
Early pediatric formulation development with new chemical entities: Opportunities of e-tongue besides human taste assessment.
Laura Isabell Immohr,Angela Dischinger,Peter Kühl,Heidemarie Kletzl,Stefan Sturm,Andreas Günther,Miriam Pein-Hackelbusch +6 more
TL;DR: Using this instrumental approach led to reproducible data versus the human taste assessment, without ethical concerns, and with a reduction in time and costs.
Journal ArticleDOI
Model-Based Drug-Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy.
Yumi Cleary,Yumi Cleary,Michael Gertz,Paul Grimsey,Andreas Günther,Katja Heinig,Kayode Ogungbenro,Leon Aarons,Aleksandra Galetin,Heidemarie Kletzl +9 more
TL;DR: In this paper, a physiologically-based pharmacokinetic (PBPK) model-based strategy was proposed to extrapolate DDI risk from healthy adults to children with SMA in an iterative manner.