Applying Modeling and Simulations for Rational Dose Selection of Novel Toll‐Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need
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DOI: 10.1002/cpt.2606
Abstract: Dual toll‐like receptor (TLR) 7 and TLR8 inhibitor enpatoran is under investigation as a treatment for lupus and coronavirus disease 2019 (COVID‐19) pneumonia. Population pharmacokinetic/pharmacodynamic (PopPK/PD) model‐based simulations, using PK and PD (inhibition of ex… read more here.
Keywords: toll like; like receptor; dose selection; inhibitor enpatoran ... See more keywords
Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development.
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DOI: 10.1002/jcph.1990
Abstract: The BCR-ABL1 inhibitor ponatinib is approved for the treatment of adults with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia, including those with the T315I mutation. We report a population pharmacokinetic (PK) model-based analysis… read more here.
Keywords: selection pediatric; dose selection; model; population ... See more keywords
Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures
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DOI: 10.1007/s10928-018-9596-7
Abstract: Modeling and simulations were used to support body weight-based dose selection for eslicarbazepine acetate (ESL) in pediatric subjects aged 4–17 years with partial-onset seizures. A one-compartment pediatric population pharmacokinetic model with formulation-specific first-order absorption, first-order elimination,… read more here.
Keywords: selection eslicarbazepine; dose selection; support; modeling simulations ... See more keywords
Population Pharmacokinetic Analysis to Assist Dose Selection of the l-Ornithine Salt of Phenylacetic Acid
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DOI: 10.1007/s40262-021-01075-1
Abstract: l-Ornithine phenylacetate is an intravenous formulation of the l-ornithine salt of phenylacetic acid under development for the treatment of hepatic encephalopathy. Very limited clinical data in patients are available, with a phase II study in… read more here.
Keywords: population pharmacokinetic; dose selection; phenylacetic acid; ornithine ... See more keywords
Target modulation and pharmacokinetics/pharmacodynamics translation of the BTK inhibitor poseltinib for model-informed phase II dose selection
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DOI: 10.1038/s41598-021-98255-7
Abstract: The selective Bruton tyrosine kinase (BTK) inhibitor poseltinib has been shown to inhibit the BCR signal transduction pathway and cytokine production in B cells (Park et al. Arthritis Res. Ther. 18, 91, 10.1186/s13075-016-0988-z, 2016). This… read more here.
Keywords: dose selection; btk; btk inhibitor; inhibitor poseltinib ... See more keywords
Model‐informed drug development for immuno‐oncology agonistic anti‐GITR antibody GWN323: Dose selection based on MABEL and biologically active dose
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DOI: 10.1111/cts.13355
Abstract: GWN323, an agonistic human anti‐GITR (glucocorticoid‐induced TNFR‐related protein) IgG1 antibody, was studied clinically as an immuno‐oncology therapeutic agent. A model‐based minimum anticipated biological effect level (MABEL) approach integrating in vitro and in vivo data informed… read more here.
Keywords: oncology; gitr; model; dose selection ... See more keywords
Model-Optimized Fluconazole Dose Selection for Critically Ill Patients Improves Early Pharmacodynamic Target Attainment without the Need for Therapeutic Drug Monitoring
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DOI: 10.1128/aac.02019-20
Abstract: Fluconazole has been associated with higher mortality compared with the echinocandins in patients treated for invasive candida infections. Underexposure from current fluconazole dosing regimens may contribute to these worse outcomes, so alternative dosing strategies require… read more here.
Keywords: drug; target attainment; model; dose selection ... See more keywords
Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents
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DOI: 10.1128/aac.02309-18
Abstract: In June 2017, The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, organized a workshop entitled “Pharmacokinetics-Pharmacodynamics (PK/PD) for Development of Therapeutics against Bacterial Pathogens” to discuss details and… read more here.
Keywords: pharmacodynamics development; drug; development; dose selection ... See more keywords
Optimal dose selection in oncology biologics development: Need for a paradigm shift.
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DOI: 10.1200/jco.2021.39.15_suppl.3093
Abstract: 3093 Background: In oncology, the recommended phase 2 dose (RP2D) is typically selected from the first-in-patient (FIP) dose escalation and then carried forward to late stage trials. The RP2D is often informed by limited data… read more here.
Keywords: oncology biologics; optimization; dose selection; oncology ... See more keywords
Dose Selection of Ropivacaine for Spinal Anesthesia in Elderly Patients with Hip Fracture: An Up-Down Sequential Allocation Study
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DOI: 10.2147/cia.s371219
Abstract: Objective The dose selection of ropivacaine for spinal anesthesia in clinical work mainly depends on the experience of the anesthesiologist. In this study, a prospective and modified up-down sequential allocation design was used to provide… read more here.
Keywords: spinal anesthesia; ropivacaine spinal; selection ropivacaine; dose selection ... See more keywords