Results 11 to 20 of about 6,245 (194)

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics & Systems Pharmacology
Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik deGreef   +10 more
doaj   +2 more sources

Automated Pharmacometric Model Development by Leveraging Low-Dimensional Neural ODEs and LASSO Regression. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Current pharmacometrics (PMX) model development is a manual process with iterative model building, fitting, and evaluation, which can be resource‐intensive and time‐consuming. Existing automated model development approaches utilize algorithms that still rely on iterative processes and perform model selection based on goodness‐of‐fit criteria ...
Bräm DS, Steiert B, Steffens B, Pfister M, Koch G.   +4 more
europepmc   +2 more sources

PMX-CovEval: A Framework Including a Simulated Pharmacokinetic Database for Covariate Model Building Methods Benchmarking. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT The development of new methods for covariate model building (CMB) in population pharmacokinetics (popPK) highlights the need for a standardized evaluation framework for method benchmarking. This data paper introduces PMX‐CovEval, a framework including a collection of datasets based on 127 distinct scenarios.
Karlsen M, Azé J, Bringay S, Poncelet P, Fabre D, Marchionni D, Calvier EAM.   +6 more
europepmc   +2 more sources

The Empirical Bayes Variational Autoencoder-A Neural ODE Approach for Population Modeling in Pharmacology. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Variational autoencoders (VAEs) combined with neural ordinary differential equations provide a flexible framework for exploring neural latent‐variable models in population pharmacokinetics. In this work, we investigate an empirical Bayes VAE formulation that integrates encoder–decoder architectures with covariate‐dependent population priors ...
Baaz M, Sjöberg A, Jirstrand M.
europepmc   +2 more sources

Pharmacometrics: Focus on the Patient [PDF]

CPT: Pharmacometrics & Systems Pharmacology, 2014
Pharmacometrics, whether using simple or complex models, has contributed to rational and efficient drug development,(1-3) with the main focus on early drug development.(4) This article describes why opportunities more directly focused on the patient abound in late stage development, illustrating the concept with three innovative examples which focus on
Dumitrescu, T Pene, Fossler, MJ, Schmith, VD   +2 more
openaire   +2 more sources

The clinical utility of pharmacometric models [PDF]

British Journal of Clinical Pharmacology, 2018
Pharmacometric models are powerful tools that can be used for a variety of purposes in clinical pharmacology, drug development and dose individualization. Lewis Sheiner famously described the process of learning versus confirming in the setting of drug development 1 and as applied to pharmacometrics.
Shaun S. Kumar, Eman Biltaji, Robert Bies, Catherine M. Sherwin   +3 more
openaire   +4 more sources

A generic framework for the physiologically‐based pharmacokinetic platform qualification of PK‐Sim and its application to predicting cytochrome P450 3A4–mediated drug–drug interactions

CPT: Pharmacometrics & Systems Pharmacology, 2021
The success of applications of physiologically‐based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a
Sebastian Frechen, Juri Solodenko, Thomas Wendl, André Dallmann, Ibrahim Ince, Thorsten Lehr, Jörg Lippert, Rolf Burghaus   +7 more
doaj   +1 more source

Phase II Dose Selection for Alpha Synuclein–Targeting Antibody Cinpanemab (BIIB054) Based on Target Protein Binding Levels in the Brain

CPT: Pharmacometrics & Systems Pharmacology, 2020
This modeling and simulation analysis was aimed at selecting doses of cinpanemab (BIIB054), a monoclonal antibody targeting aggregated α‐synuclein, for a phase II study in Parkinson’s disease (PD).
Mita Kuchimanchi, Michael Monine, Kumar Kandadi Muralidharan, Caroline Woodward, Natalia Penner   +4 more
doaj   +1 more source

Physiologically Based Pharmacokinetic Modeling of Monoclonal Antibodies in Pediatric Populations Using PK-Sim

Frontiers in Pharmacology, 2020
Physiologically based pharmacokinetic (PBPK) models are increasingly used to support pediatric dose selection for small molecule drugs. In contrast, only a few pediatric PBPK models for therapeutic antibodies have been published recently, and the ...
Sumit Basu, Yi Ting (Kayla) Lien, Valvanera Vozmediano, Jan-Frederik Schlender, Thomas Eissing, Stephan Schmidt, Christoph Niederalt   +6 more
doaj   +1 more source

Mechanistic Modeling of Intra‐Tumor Spatial Distribution of Antibody‐Drug Conjugates: Insights into Dosing Strategies in Oncology

Clinical and Translational Science, 2021
Antibody drug conjugates (ADCs) provide targeted delivery of cytotoxic agents directly inside tumor cells. However, many ADCs targeting solid tumors have exhibited limited clinical efficacy, in part, due to insufficient penetration within tumors.
Jared Weddell, Manoj S. Chiney, Sumit Bhatnagar, John P. Gibbs, Mohamad Shebley   +4 more
doaj   +1 more source