Publications by authors named "J F Marier"
Recombinant von Willebrand factor (rVWF, vonicog alfa, Takeda Pharmaceuticals USA) is indicated in adults diagnosed with von Willebrand disease (VWD). In this study, the exposure-response (ER) relationship between VWF activity (VWF:RCo) or factor VIII activity (FVIII:C) and spontaneous bleeding events (BEs) was evaluated in adults with severe VWD receiving rVWF prophylaxis for up to 1 year. This secondary analysis included 23 patients receiving rVWF prophylaxis in the open-label, phase 3 prophylaxis trial (NCT02973087).
View Article and Find Full Text PDFSitravatinib (MGCD516) is an orally available, small molecule, tyrosine kinase inhibitor that has been evaluated in patients with advanced solid tumors. Concentration-corrected QT interval (QTc; C-QTc) modeling was undertaken, using 767 matched concentration-ECG observations from 187 patients across two clinical studies in patients with advanced solid malignancies, across a dose range of 10-200 mg, via a linear mixed-effects (LME) model. The effect on heart rate (HR)-corrected QT interval via Fridericia's correction method (QTcF) at the steady-state maximum concentration (C) for the sitravatinib proposed therapeutic dosing regimen (100 mg malate once daily [q.
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- Trilaciclib is an intravenous drug that protects against blood cell depletion caused by chemotherapy, specifically studied in patients with extensive-stage small cell lung cancer (ES-SCLC) and triple-negative breast cancer (TNBC).
- A population pharmacokinetics analysis revealed that factors like sex, age, and body size influence how the body processes trilaciclib, but they don't significantly alter its efficacy.
- The drug provided effective protection against myelosuppression without affecting the cancer-fighting properties of chemotherapy, though higher doses were linked to increased side effects such as headaches and injection site reactions.
Evaluation of covariate effects using forest plots and introduction to the coveffectsplot R package.
CPT Pharmacometrics Syst Pharmacol
October 2022
The current tutorial describes why forest plots are needed for an effective communication of covariates effects, how they are constructed, and how they should be presented. Simulation-based methodologies allowing the user to evaluate the marginal impact of changing one covariate at a time or by considering the joint effects of correlated covariates are introduced along with graphical tools for an optimal assessment of the covariate effects. The R package coveffectsplot and an associated R Shiny application are provided to facilitate the design and construction of forest plots for the visualization of covariate effects.
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- Teduglutide is a synthesized version of a natural hormone that helps maintain the health of the intestinal lining and is specifically used to treat patients with short bowel syndrome who rely on parenteral support.
- A study involving 219 patients with short bowel syndrome and 259 non-SBS subjects provided insights into the drug's pharmacokinetics, showing that body weight and kidney function impact how the drug is processed in the body.
- Daily administration of 0.05 mg/kg of teduglutide led to a significant decrease in parenteral support needs, and both adult and pediatric patients showed similar responses to the treatment.