13 hasil untuk "Farrell, Colm"
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Artikel Jurnal Teks lengkap
A Physiologically Based Pharmacokinetic Model to Predict Potential Drug–Drug Interactions and Inform Dosing of Acumapimod, an Oral p38 MAPK Inhibitor
Acumapimod, an investigational oral p38 mitogen‐activated protein kinase inhibitor for treatment during severe acute exacerbations of chronic obstructive pulmonary disease, is metabolized primarily by cytochrome P450 3A4 (CYP3A4) and is a P‐glycoprotein (P‐gp) substrate. Concerns about drug–drug…
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Population pharmacokinetic/ pharmacodynamic modelling of eltrombopag in healthy volunteers and subjects with chronic liver disease
AIMS: To characterize the pharmacokinetics (PK)/pharmacodynamics (PD) of eltrombopag in chronic liver disease (CLD). METHODS: The PK/PD model was developed using data from 79 CLD patients using nonlinear mixed-effects modelling. RESULTS: The PK of eltrombopag were described by a two-compartment…
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Artikel Jurnal Teks lengkap
Population pharmacokinetic modeling and simulation of maribavir to support dose selection and regulatory approval in adolescents with posttransplant refractory cytomegalovirus
Maribavir was approved by the US Food and Drug Administration for the treatment of patients aged ≥12 years and weighing ≥35 kg with posttransplant cytomegalovirus infection/disease refractory (with/without resistance) to valganciclovir, ganciclovir, cidofovir, or foscarnet, with an oral dose of 400…
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Artikel Jurnal Teks lengkap
Safety, pharmacokinetics, and pharmacodynamics of intravenous ferric carboxymaltose in children with iron deficiency anemia
BACKGROUND: Iron deficiency is the primary cause of anemia in children. Intravenous (IV) iron formulations circumvent malabsorption and rapidly restore hemoglobin. METHODS: This Phase 2, non-randomized, multicenter study characterized the safety profile and determined appropriate dosing of ferric…
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Artikel Jurnal Teks lengkap
Population pharmacokinetic and pharmacodynamic analyses of safinamide in subjects with Parkinson's disease
Safinamide is an orally administered α‐aminoamide derivative with both dopaminergic and non‐dopaminergic properties. Nonlinear mixed effects models for population pharmacokinetic (PK) and pharmacokinetic–pharmacodynamic (PKPD) analyses were developed using records from, respectively, 623 and 668…
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Artikel Jurnal Teks lengkap
Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease
BACKGROUND: Population pharmacokinetic methods were used to characterize the pharmacokinetics of fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) when administered as a fixed-dose combination via a single closed…
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Artikel Jurnal Teks lengkap
Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials
B cell stimulating factor (BLyS) and a proliferation‐inducing ligand (APRIL) are targets for novel treatments in patients with systemic lupus erythematosus (SLE). Atacicept is a recombinant, soluble fusion protein that blocks BLyS and APRIL activity. This study characterized the pharmacokinetic…
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Population pharmacokinetics of recombinant human C1 inhibitor in patients with hereditary angioedema
AIMS: To characterize the pharmacokinetics (PK) of recombinant human C1 inhibitor (rhC1INH) in healthy volunteers and hereditary angioedema (HAE) patients. METHODS: Plasma levels of C1INH following 294 administrations of rhC1INH in 133 subjects were fitted using nonlinear mixed-effects modelling…
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Artikel Jurnal Teks lengkap
A population pharmacokinetic meta‐analysis of custirsen, an antisense oligonucleotide, in oncology patients and healthy subjects
AIMS: Custirsen (OGX‐011/TV‐1011), a second‐generation antisense oligonucleotide that reduces clusterin production, is under investigation with chemotherapy in prostate and lung cancer. This meta‐analysis evaluated the population pharmacokinetics (PK) of custirsen in cancer patients and healthy…
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Artikel Jurnal Teks lengkap
Population pharmacokinetics and exposure–response relationships of maribavir in transplant recipients with cytomegalovirus infection
Maribavir is approved for management of post-transplant cytomegalovirus (CMV) infections refractory and/or resistant to CMV therapies at a dose of 400 mg twice daily (BID). Population pharmacokinetic (PopPK) and exposure–response analyses were conducted to support the appropriateness of 400 mg BID…
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Artikel Jurnal Teks lengkap
Population pharmacokinetics of farletuzumab, a humanized monoclonal antibody against folate receptor alpha, in epithelial ovarian cancer
PURPOSE: The purpose of this analysis was to develop a population pharmacokinetic model for farletuzumab, a humanized immunoglobulin (Ig)G(1) monoclonal antibody (mAb) to the folate receptor alpha, which is a receptor over-expressed in ovarian cancer, but largely absent from normal tissue. METHODS…
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Development of Xanamem, an isoform 1 specific inhibitor of 11‐βHSD, as a procognitive and disease modifying treatment for mild/moderate Alzheimer’s disease. A pharmacodynamic and biomarker driven approach
BACKGROUND: Selecting the optimal dose for clinical development is especially problematic for drugs directed at CNS‐specific targets. For drugs with a novel mechanism of action, these problems are often greater. We describe Xanamem’s clinical pharmacology, including the approach to dose selection…
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Artikel Jurnal Teks lengkap
Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report
Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for…