Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling
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DOI: 10.1002/cpdd.1531
Abstract: There is a shortage of data in clinical studies of neonatal populations, which often utilize extrapolation strategies and model simulation techniques to support drug development and clinical applications. This study established an adult physiological‐based pharmacokinetic/pharmacodynamic… read more here.
Keywords: neonates using; based pharmacokinetic; physiological based; extrapolation ... See more keywords
Physiologically‐Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug–Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations
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DOI: 10.1002/cpt.1693
Abstract: Physiologically‐based pharmacokinetic (PBPK) modeling has been extensively used to quantitatively translate in vitro data and evaluate temporal effects from drug–drug interactions (DDIs), arising due to reversible enzyme and transporter inhibition, irreversible time‐dependent inhibition, enzyme induction,… read more here.
Keywords: based pharmacokinetic; pbpk modeling; physiologically based; drug ... See more keywords
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
Physiologically‐Based Pharmacokinetic Modelling to Investigate Baricitinib and Tofacitinib Dosing Recommendations for COVID‐19 in Geriatrics
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DOI: 10.1002/cpt.2600
Abstract: Janus kinase (JAK) inhibitors baricitinib and tofacitinib are recommended by the US National Institutes of Health as immunomodulatory drugs for coronavirus disease 2019 (COVID‐19) treatment. In addition, baricitinib has recently received Emergency Use Authorization from… read more here.
Keywords: baricitinib; based pharmacokinetic; renal impairment; baricitinib tofacitinib ... See more keywords
Physiologically‐Based Pharmacokinetic Modeling‐Guided Dose Management of Oral Anticoagulants when Initiating Nirmatrelvir/Ritonavir (Paxlovid) for COVID‐19 Treatment
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DOI: 10.1002/cpt.2687
Abstract: Patients with coronavirus disease 2019 (COVID‐19) with cardiovascular diseases who are at higher risk of progressing to critical illness should be treated with nirmatrelvir/ritonavir (Paxlovid). Ritonavir, the booster in nirmatrelvir/ritonavir, modulates multiple drug metabolizing enzymes… read more here.
Keywords: ritonavir paxlovid; based pharmacokinetic; nirmatrelvir ritonavir; physiologically based ... See more keywords
The Impact of Dexamethasone and Prednisone on Apixaban and Rivaroxaban Exposure in COVID‐19 Patients: A Physiologically Based Pharmacokinetic Modeling Study
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DOI: 10.1002/cpt.3491
Abstract: Dexamethasone (DEX) is currently the treatment of choice for patients with oxygen‐dependent COVID‐19. It has been observed, primarily in vitro, that dexamethasone induces the expression of CYP3A and the ABCB1 gene, which encodes P‐glycoprotein (P‐gp).… read more here.
Keywords: covid; dex; based pharmacokinetic; pharmacokinetic modeling ... See more keywords
Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study.
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DOI: 10.1002/cpt.70082
Abstract: Mezigdomide (MEZI) is an oral, highly potent CELMoD™ agent with promising antitumor and immune-stimulatory activity, optimized for Aiolos and Ikaros degradation. Preclinical evidence suggests MEZI is primarily metabolized by cytochrome P450 (CYP) 3A4/5 and has… read more here.
Keywords: pbpk; based pharmacokinetic; drug drug; drug ... See more keywords
A physiologically based pharmacokinetic model of vitamin D
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DOI: 10.1002/jat.3489
Abstract: Despite the plethora of studies discussing the benefits of vitamin D on physiological functioning, few mathematical models of vitamin D predict the response of the body on low‐concentration supplementation of vitamin D under sunlight‐restricted conditions.… read more here.
Keywords: pharmacokinetic model; based pharmacokinetic; physiologically based; model ... See more keywords
New insights into the vancomycin‐induced nephrotoxicity using in vitro metabolomics combined with physiologically based pharmacokinetic modeling
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DOI: 10.1002/jat.3951
Abstract: Vancomycin is a first‐line treatment for invasive infections caused by multidrug‐resistant gram‐positive bacteria. However, vancomycin‐induced nephrotoxicity is an increasing burden, particularly in patients with complex life‐threatening conditions. Vancomycin‐induced nephrotoxicity associated with clinically relevant exposure on… read more here.
Keywords: vancomycin; based pharmacokinetic; induced nephrotoxicity; physiologically based ... See more keywords
Brexpiprazole pharmacokinetics in CYP2D6 poor metabolizers: Using physiologically-based pharmacokinetic modeling to optimize time-to-effective concentrations (JCP-21-Apr-211-R2).
Sign Up to like & getrecommendations! Published in 2021 at "Journal of clinical pharmacology"
DOI: 10.1002/jcph.1946
Abstract: Brexpiprazole is an oral antipsychotic agent indicated for use in patients with schizophrenia, or as adjunctive treatment for major depressive disorder (MDD). As CYP2D6 contributes significantly to brexpiprazole metabolism, there is a label-recommended 50% reduction… read more here.
Keywords: based pharmacokinetic; physiologically based; time effective; effective concentrations ... See more keywords
Determination of Vatiquinone Drug‐Drug Interactions, as CYP450 Perpetrator and Victim, Using Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation
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DOI: 10.1002/jcph.6133
Abstract: Vatiquinone, a 15‐lipoxygenase inhibitor, is in development for patients with Friedreich's ataxia. Physiologically based pharmacokinetic (PBPK) modeling addressed drug‐drug interaction gaps without additional studies. A PBPK model (Simcyp Simulator version 21, full model) was developed… read more here.
Keywords: pharmacokinetic pbpk; vatiquinone; based pharmacokinetic; drug ... See more keywords