Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
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
Development and Evaluation of Multimodel Informed Precision Dosing Tool for Optimizing Vancomycin Therapy in Pediatric Patients.
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DOI: 10.1097/ftd.0000000000001392
Abstract: BACKGROUND The narrow therapeutic window and high pharmacokinetic (PK) variability of vancomycin may lead to trough concentrations outside the usual therapeutic range, requiring dose adjustments. In this study, we aimed to identify suitable pediatric vancomycin… read more here.
Keywords: multimodel informed; tool; precision dosing; informed precision ... See more keywords
Overcoming barriers to implementing precision dosing with 5‐fluorouracil and capecitabine
Sign Up to like & getrecommendations! Published in 2021 at "British Journal of Clinical Pharmacology"
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
Recommended approaches for integration of population pharmacokinetic modelling with precision dosing in clinical practice
Sign Up to like & getrecommendations! Published in 2024 at "British Journal of Clinical Pharmacology"
DOI: 10.1111/bcp.16335
Abstract: Current methods of dose determination have contributed to suboptimal and inequitable health outcomes in underrepresented patient populations. The persistent demand to individualise patient treatment, alongside increasing technological feasibility, is leading to a growing adoption of… read more here.
Keywords: integration; population pharmacokinetic; precision dosing; precision ... 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
Hepatic Metabolic Enzyme Activity with Endogenous Substances-current Status, Challenges and Limitations.
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DOI: 10.2174/0113892002289027240809114634
Abstract: Precision dosing is essential in improving drug efficacy and minimizing adverse reactions, especially in liver impaired patients. However, there is no objective index to directly evaluate the body's ability to metabolize specific drugs. Many factors… read more here.
Keywords: precision dosing; endogenous substances; hepatic metabolic; drug ... 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