Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study
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DOI: 10.1002/cpt.2092
Abstract: Accelerated drug development for diseases with high unmet need demands patient focus without compromising scientific rigor. Precision dosing informed by physiologically-based pharmacokinetic (PBPK) models will enable inclusive clinical trials and narrow the gap between clinical… read more here.
Keywords: drug development; mass balance; based pharmacokinetic; precision dosing ... See more keywords
Overcoming barriers to implementing precision dosing with 5‐fluorouracil and capecitabine
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DOI: 10.1111/bcp.14723
Abstract: Despite advances in targeted cancer therapy, the fluoropyrimidines 5‐fluorouracil (5FU) and capecitabine continue to play an important role in oncology. Historically, dosing of these drugs has been based on body surface area. This approach has… read more here.
Keywords: precision dosing; capecitabine; implementing precision; overcoming barriers ... See more keywords
Precision dosing‐based optimisation of paroxetine during pregnancy for poor and ultrarapid CYP2D6 metabolisers: a virtual clinical trial pharmacokinetics study
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Pharmacy and Pharmacology"
DOI: 10.1111/jphp.13281
Abstract: Paroxetine has been demonstrated to undergo gestation‐related reductions in plasma concentrations, to an extent which is dictated by the polymorphic state of CYP 2D6. However, knowledge of appropriate dose titrations is lacking. read more here.
Keywords: paroxetine pregnancy; dosing based; optimisation paroxetine; precision dosing ... See more keywords
Precision Dosing of Targeted Therapies Is Ready for Prime Time
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DOI: 10.1158/1078-0432.ccr-20-4555
Abstract: Fixed dosing of oral targeted therapies is inadequate in the era of precision medicine. Personalized dosing, based on pharmacokinetic (PK) exposure, known as therapeutic drug monitoring (TDM), is rational and supported by increasing evidence. The… read more here.
Keywords: dosing targeted; therapies ready; targeted therapies; exposure ... See more keywords
Physiologically based modelling of the antiplatelet effect of aspirin: A tool to characterize drug responsiveness and inform precision dosing
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DOI: 10.1371/journal.pone.0268905
Abstract: A computational approach involving mathematical modeling and in silico experiments was used to characterize the determinants of extent and duration of platelet cyclooxygenase (COX)-1 inhibition by aspirin and design precision dosing in patients with accelerated… read more here.
Keywords: precision dosing; cox inhibition; physiologically based; drug ... See more keywords
Precision dosing of targeted anticancer drugs—challenges in the real world
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DOI: 10.21037/16980
Abstract: Abstract: The prerequisites for the successful implementation of therapeutic drug monitoring (TDM) include high inter-subject variation, low inter-occasion variation, narrow therapeutic index and a strong link between plasma drug concentrations and clinical effects. The degree… read more here.
Keywords: real world; precision dosing; anticancer drugs; precision ... See more keywords
Role of pharmacokinetic modeling and simulation in precision dosing of anticancer drugs
Sign Up to like & getrecommendations! Published in 2017 at "Translational cancer research"
DOI: 10.21037/tcr.2017.09.14
Abstract: The prospect of precision dosing in oncology is attractive for several reasons. Many anticancer drugs display narrow therapeutic indices, where suboptimal therapy may lead to severe patient outcomes. Clinical study participant recruitment is seldom extended… read more here.
Keywords: pharmacokinetic modeling; precision dosing; anticancer drugs; dosing anticancer ... 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
β-lactam precision dosing in critically ill children: Current state and knowledge gaps
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DOI: 10.3389/fphar.2022.1044683
Abstract: There has been emerging interest in implementing therapeutic drug monitoring and model-informed precision dosing of β-lactam antibiotics in critically ill patients, including children. Despite a position paper endorsed by multiple international societies that support these… read more here.
Keywords: ill children; critically ill; lactam precision; precision dosing ... See more keywords
Reinforcement learning as an innovative model-based approach: Examples from precision dosing, digital health and computational psychiatry
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2022.1094281
Abstract: Model-based approaches are instrumental for successful drug development and use. Anchored within pharmacological principles, through mathematical modeling they contribute to the quantification of drug response variability and enables precision dosing. Reinforcement learning (RL)—a set of… read more here.
Keywords: precision dosing; approach; model based; digital health ... See more keywords
External Evaluation of Population Pharmacokinetic Models to Inform Precision Dosing of Meropenem in Critically Ill Patients
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DOI: 10.3389/fphar.2022.838205
Abstract: Routine clinical meropenem therapeutic drug monitoring data can be applied to model-informed precision dosing. The current study aimed to evaluate the adequacy and predictive capabilities of the published models with routine meropenem data and identify… read more here.
Keywords: precision dosing; meropenem concentrations; external evaluation; meropenem ... See more keywords