6 papers
Conditional bootstrap for non-linear mixed effects models
Sofia Kaisaridi, Moreno Ursino, Emmanuelle Comets
Background and Objective: Uncertainty in non-linear mixed effect models is often assessed using the Fisher information matrix to derive the standard errors of estimation. The boots…
Latent Neural-ODE for Model-Informed Precision Dosing: Overcoming Structural Assumptions in Pharmacokinetics
Benjamin Maurel, Agathe Guilloux, Sarah Zohar +2
Accurate estimation of tacrolimus exposure, quantified by the area under the concentration-time curve (AUC), is essential for precision dosing after renal transplantation. Current…
Sample size reassessment in Bayesian hybrid clinical trials
Marco Ratta, Pavel Mozgunov, Sandrine Boulet +1
The use of historical controls offers a valuable alternative when traditional randomized controlled trials are not feasible. However, such approaches may introduce bias due to temp…
U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization in early-phase oncology trials based on Dose-Exposure, Safety, Pharmacodynamics, Efficacy
Anaïs Andrillon, Sandrine Micallef, Moreno Ursino +2
With the development of novel therapies such as molecularly targeted agents and immunotherapy, the maximum tolerated dose paradigm that "more is better" does not necessarily hold a…
In silico clinical trials in drug development: a systematic review
Bohua Chen, Lucia Chantal Schneider, Christian Röver +15
In the context of clinical research, computational models have received increasing attention over the past decades. In this systematic review, we aimed to provide an overview of th…
Straightforward Phase I Dose-Finding Design for Healthy Volunteers Accounting for Surrogate Activity Biomarkers
Sandrine Boulet, Emmanuelle Comets, Antoine Guillon +5
Conventionally, a first-in-human phase I trial in healthy volunteers aims to confirm the safety of a drug in humans. In such situations, volunteers should not suffer from any safet…