Thursday 16 October, 2025
Objectives: Item response theory (IRT) has shown to be a valuable asset for the analysis of (late phase) clinical trials…
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Evaluation of Darigabat QTc Prolongation in Healthy Volunteers: a Concentration-QTcF Analysis
Thursday 16 October, 2025
Objectives: Darigabat (CVL-865; PF-06372865) is a novel, brain-penetrable positive allosteric modulator (PAM) of α2/3/5 subunit-containing gamma-amino-butyric-acid type A (GABAA) receptors,…
Read moreCharacterization of absorption kinetics of oral esketamine in healthy volunteers
Thursday 16 October, 2025
Objectives: The interest in esketamine as antidepressant drug remains high ever since it first got registered as an option for…
Read moreNew features in PFIM for optimal design in nonlinear mixed effects models using the S4 object system in R
Thursday 16 October, 2025
Introduction: Nonlinear mixed effects models (NLMEM) are widely used in model-based drug development to analyse longitudinal data. The use of…
Read moreDesign evaluation and optimisation in nonlinear mixed effects models with the R package PFIM 6.0
Thursday 16 October, 2025
Objectives: Nonlinear mixed effects models (NLMEMs) are widely used in model-based drug development to analyse longitudinal data. For optimising the…
Read moreDesign evaluation and optimisation in nonlinear mixed effects models with the R package PFIM
Thursday 16 October, 2025
Objectives: Nonlinear mixed effects models (NLMEMs) are widely used in model-based drug development to analyse longitudinal data. For optimising the…
Read moreOptimizing the value of preclinical data for the design of first-in-human clinical studies with oral cabazitaxel through population pharmacokinetic modelling
Thursday 16 October, 2025
Introduction Cabazitaxel is currently approved as an intravenous (IV) formulation for the second line treatment of hormone refractory prostate cancer…
Read moreGeneralized FOCE with Pumas
Thursday 16 October, 2025
Introduction: Traditionally, the first-order estimation method (FOCE) [1] has been associated with the Gaussian error models. However, when FOCE is…
Read moreOn the error of the Laplace approximation when lags and duration parameters have between-subject variation
Thursday 16 October, 2025
It is well known that estimation based on the Laplace approximation, such as the First Order Conditional Estimation (FOCE), of…
Read morepedPower – An R package to aid pediatric clinical trial design and exposure evaluation
Thursday 16 October, 2025
Introduction As one step in the pediatric development of drugs that have been evaluated in adults, pediatric trials are conducted…
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