Model‐Informed Drug Development for Antimicrobials: Translational PK and PK/PD Modeling to Predict an Efficacious Human Dose for Apramycin
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2104
Abstract: Apramycin represents a subclass of aminoglycoside antibiotics that has been shown to evade almost all mechanisms of clinically relevant aminoglycoside resistance. Model‐informed drug development may facilitate its transition from preclinical to clinical phase. This study… read more here.
Keywords: model informed; model; informed drug; dose ... See more keywords
Model Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2491
Abstract: Leveraging limited clinical and non-clinical data through modeling approaches facilitates new drug development and regulatory decision making amid the Coronavirus Disease 2019 (COVID-19) pandemic. Model-informed drug development (MIDD) is an essential tool to integrate those… read more here.
Keywords: drug development; model informed; new drug; drug ... See more keywords
Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release Tofacitinib
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DOI: 10.1002/cpt.576
Abstract: Extended‐release (XR) formulations enable less frequent dosing vs. conventional (e.g., immediate release (IR)) formulations. Regulatory registration of such formulations typically requires pharmacokinetic (PK) and clinical efficacy data. Here we illustrate a model‐informed, exposure–response (E‐R) approach… read more here.
Keywords: tofacitinib; extended release; model informed; registration ... See more keywords
Model-Informed Deep Q-Networks to Guide Infliximab Dosing in Pediatric Crohn's Disease.
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DOI: 10.1002/cpt.70118
Abstract: Model‐informed precision dosing (MIPD) utilizes pharmacokinetic/pharmacodynamic (PK/PD) models to optimize drug therapy. However, conventional MIPD often requires manual simulation and regimen selection, which are time‐consuming and demand specialized expertise. Reinforcement learning (RL), in which an… read more here.
Keywords: informed deep; crohn disease; infliximab dosing; model informed ... See more keywords
From lab-to-clinic with model informed formulation development: a case study of hydroxyzine SR tablets
Sign Up to like & getrecommendations! Published in 2025 at "Xenobiotica"
DOI: 10.1080/00498254.2025.2497045
Abstract: Abstract Model Informed Formulation Development (MIFD) uses physiologically based pharmacokinetic (PBPK) modelling and other in silico tools to facilitate new product development. These tools help set target profiles, predict in vivo formulation performance, guide iterative… read more here.
Keywords: formulation; drug; hydroxyzine; model ... See more keywords
Evaluation of the Real-World Practice of Model-Informed Therapeutic Drug Monitoring and Its Association With Pharmacokinetic Target Attainment Rates: A Large-Scale, Single-Center Retrospective Study.
Sign Up to like & getrecommendations! Published in 2025 at "Therapeutic drug monitoring"
DOI: 10.1097/ftd.0000000000001402
Abstract: BACKGROUND Model-informed therapeutic drug monitoring (TDM) optimizes drug-dosing regimens using concentration measurements and mathematical models. Despite its importance, the implementation of TDM and pharmacokinetic (PK) target attainment rates may vary across drug and clinical settings.… read more here.
Keywords: drug; target attainment; model informed; attainment rates ... See more keywords
MISD: Model-Informed Stable Diffusion Model for Limited Noisy Data CT Reconstruction
Sign Up to like & getrecommendations! Published in 2025 at "IEEE Transactions on Computational Imaging"
DOI: 10.1109/tci.2025.3617237
Abstract: Limited data computed tomography (LDCT) plays a critical role in accelerating the scanning process and reducing radiation exposure for patients. However, LDCT reconstruction is inherently an ill-posed inverse problem, often resulting in pronounced edge artifacts… read more here.
Keywords: misd model; stable diffusion; reconstruction; model informed ... See more keywords
Model informed dosing of hydroxycholoroquine in COVID‐19 patients: Learnings from the recent experience, remaining uncertainties and gaps
Sign Up to like & getrecommendations! Published in 2020 at "British Journal of Clinical Pharmacology"
DOI: 10.1111/bcp.14436
Abstract: In the absence of a commonly agreed dosing protocol based on pharmacokinetic (PK) considerations, the dose and treatment duration for hydroxychloroquine (HCQ) in COVID‐19 disease currently vary across national guidelines and clinical study protocols. We… read more here.
Keywords: covid patients; hydroxycholoroquine covid; dosing hydroxycholoroquine; model informed ... See more keywords
Model‐informed drug repurposing: A pharmacometric approach to novel pathogen preparedness, response and retrospection
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DOI: 10.1111/bcp.14760
Abstract: During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model‐informed drug… read more here.
Keywords: novel pathogen; drug repurposing; model informed; drug ... See more keywords
Pharmacokinetic equations versus Bayesian guided vancomycin monitoring: Pharmacokinetic model and model‐informed precision dosing trial simulations
Sign Up to like & getrecommendations! Published in 2022 at "Clinical and Translational Science"
DOI: 10.1111/cts.13210
Abstract: The recently released revised vancomycin consensus guideline endorsed area under the concentration‐time curve (AUC) guided monitoring. Means to AUC‐guided monitoring include pharmacokinetic (PK) equations and Bayesian software programs, with the latter approach being preferable. We… read more here.
Keywords: guided monitoring; model; informed precision; bayesian guided ... See more keywords
Model Informed Drug Development: Novel Oncology Agents are Lost in Translation
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DOI: 10.1158/1078-0432.ccr-19-2482
Abstract: Excitement around and investment in oncology drug development are at unprecedented levels. To maximize the health impact and productivity of this research and development investment, quantitative modeling should impact key decisions in early clinical oncology… read more here.
Keywords: informed drug; development; drug development; oncology ... See more keywords