Application of a Bayesian approach to physiological modelling of mavoglurant population pharmacokinetics
T Wendling, S Dumitras, K Ogungbenro… - … of pharmacokinetics and …, 2015 - Springer
Mavoglurant (MVG) is an antagonist at the metabotropic glutamate receptor-5 currently under
clinical development at Novartis Pharma AG for the treatment of central nervous system …
clinical development at Novartis Pharma AG for the treatment of central nervous system …
Model-based evaluation of the impact of formulation and food intake on the complex oral absorption of mavoglurant in healthy subjects
…, K Ogungbenro, E Pigeolet, S Dumitras… - Pharmaceutical …, 2015 - Springer
Purpose To compare the pharmacokinetics of intravenous (IV), oral immediate-release (IR)
and oral modified-release (MR) formulations of mavoglurant in healthy subjects, and to …
and oral modified-release (MR) formulations of mavoglurant in healthy subjects, and to …
[HTML][HTML] Reduction of a whole-body physiologically based pharmacokinetic model to stabilise the Bayesian analysis of clinical data
T Wendling, N Tsamandouras, S Dumitras, E Pigeolet… - The AAPS journal, 2016 - Springer
Whole-body physiologically based pharmacokinetic (PBPK) models are increasingly used in
drug development for their ability to predict drug concentrations in clinically relevant tissues …
drug development for their ability to predict drug concentrations in clinically relevant tissues …
[PDF][PDF] Effect of cimetidine, a model drug for inhibition of the organic cation transport (OCT2/MATE1) in the kidney, on the pharmacokinetics of glycopyrronium
S Dumitras, R Sechaud, A Drollmann, P Pal… - Int J Clin Pharmacol …, 2013 - researchgate.net
Objective: Glycopyrronium (NVA237), a novel once-daily long-acting muscarinic antagonist (LAMA),
has recently been approved for maintenance treatment of COPD. This study …
has recently been approved for maintenance treatment of COPD. This study …
Siponimod pharmacokinetics, safety, and tolerability in combination with the potent CYP3A4 inhibitor itraconazole in healthy subjects with different CYP2C9 …
…, A Feller, F Huth, S Neelakantham, S Dumitras - European Journal of …, 2019 - Springer
… Swati Dumitras supported the conceptualization of the study, provided critical revision of
the manuscript for the content, and supervised the overall research. All authors made a …
the manuscript for the content, and supervised the overall research. All authors made a …
Siponimod pharmacokinetics, safety, and tolerability in combination with rifampin, a CYP2C9/3A4 inducer, in healthy subjects
…, F Huth, AM Davidson, S Dumitras… - European journal of …, 2018 - Springer
Purpose To assess the potential pharmacokinetic (PK) interactions between siponimod and
rifampin, a strong CYP3A4/moderate CYP2C9 inducer, in healthy subjects. Methods This …
rifampin, a strong CYP3A4/moderate CYP2C9 inducer, in healthy subjects. Methods This …
[HTML][HTML] Safety, tolerability, pharmacodynamics and pharmacokinetics of intravenous siponimod: a randomized, open-label study in healthy subjects
…, A Gardin, C Gray, S Neelakantham, S Dumitras… - Clinical …, 2020 - Elsevier
Purpose The goal of this study was to assess the safety, tolerability, pharmacodynamics (PD)
and pharmacokinetics (PK) of intravenous (IV) siponimod in healthy subjects. Methods This …
and pharmacokinetics (PK) of intravenous (IV) siponimod in healthy subjects. Methods This …
Validation of an LC-MS/MS method for the quantitative determination of mavoglurant (AFQ056) in human plasma
…, S Winter, M Raccuglia, F Picard, S Dumitras… - Analytical and …, 2013 - Springer
A simple, sensitive, and selective liquid chromatography/tandem mass spectrometry method
was validated for the identification and quantification of mavoglurant (AFQ056) in human …
was validated for the identification and quantification of mavoglurant (AFQ056) in human …
Absolute Bioavailability of Single, Oral Dose of Siponimod in Healthy Subjects (P3. 402)
…, C Gray, S Neelakantham, E Legangneux, S Dumitras - 2018 - AAN Enterprises
Objective: To determine (1) the absolute bioavailability of a single oral dose of 0.25 mg
siponimod, and (2) the pharmacokinetic (PK) profile of siponimod and its metabolite following a …
siponimod, and (2) the pharmacokinetic (PK) profile of siponimod and its metabolite following a …
Safety, Tolerability and Pharmacodynamics of Intravenous Siponimod in Healthy Subjects (P3. 399)
…, A Gardin, C Gray, S Neelakantham, S Dumitras… - 2018 - AAN Enterprises
Objective: To investigate the safety, tolerability, and pharmacodynamics (PD) of intravenous
(iv) siponimod in healthy subjects to support an iv dosing regimen in patients with …
(iv) siponimod in healthy subjects to support an iv dosing regimen in patients with …