Model‐Informed Drug Development for Antimicrobials: Translational PK and PK/PD Modeling to Predict an Efficacious Human Dose for Apramycin
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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 dosing of hydroxycholoroquine in COVID‐19 patients: Learnings from the recent experience, remaining uncertainties and gaps
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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
Precision medicine technology reality not hype - The example of model-informed precision dosing
Sign Up to like & getrecommendations! Published in 2019 at "F1000Research"
DOI: 10.12688/f1000research.20489.2
Abstract: Novel technologies labelled as ‘precision medicine’ are targeting all aspects of clinical care. Whilst some technological advances are undeniably exciting, many doctors at the frontline of healthcare view precision medicine as being out of reach… read more here.
Keywords: medicine; precision medicine; model informed; medicine technology ... See more keywords
Model-Informed Precision Dosing of Antibiotics in Pediatric Patients: A Narrative Review
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DOI: 10.3389/fped.2021.624639
Abstract: Optimal pharmacotherapy in pediatric patients with suspected infections requires understanding and integration of relevant data on the antibiotic, bacterial pathogen, and patient characteristics. Because of age-related physiological maturation and non-maturational covariates (e.g., disease state, inflammation,… read more here.
Keywords: narrative review; precision dosing; model informed; drug ... See more keywords
Model-Informed Precision Dosing of Vancomycin in Hospitalized Children: Implementation and Adoption at an Academic Children’s Hospital
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DOI: 10.3389/fphar.2020.00551
Abstract: Background Model-informed precision dosing (MIPD) can serve as a powerful tool during therapeutic drug monitoring (TDM) to help individualize dosing in populations with large pharmacokinetic variation. Yet, adoption of MIPD in the clinical setting has… read more here.
Keywords: implementation; cds tool; model informed; mipd ... See more keywords
A New Framework to Implement Model-Informed Dosing in Clinical Guidelines: Piperacillin and Amikacin as Proof of Concept
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DOI: 10.3389/fphar.2020.592204
Abstract: Background: Modeling and simulation is increasingly used to study pediatric pharmacokinetics, but clinical implementation of age-appropriate doses lags behind. Therefore, we aimed to develop model-informed doses using published pharmacokinetic data and a decision framework to… read more here.
Keywords: framework; pta; model informed; critically ill ... See more keywords