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Population pharmacokinetics

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https://www.readbyqxmd.com/read/28937536/enoxaparin-population-pharmacokinetics-in-the-first-year-of-life
#1
Brady S Moffett, Marianne Galati, Donald Mahoney, YoungNa Lee-Kim, Jun Teruya, Mona D Shah, Donald L Yee
Aims Enoxaparin dosing requirements in the first year of life can be highly variable. Characterization of pharmacokinetics in this patient population can assist in dosing. METHODS: Patients less than one year post-natal age who received enoxaparin and had an anti-factor Xa activity level drawn as inpatients were identified through the pharmacy database over a five-year period. Patients on renal replacement therapy or with hyperbilirubinemia were excluded. Data collection included demographic variables, indication for enoxaparin, enoxaparin doses, anti-factor Xa activity levels, serum creatinine, hemoglobin, hematocrit, platelet count, and urine output over the previous 24 hours...
September 19, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28934640/continuous-longitudinal-infusion-of-rhigf-1-rhigfbp-3-in-extremely-preterm-infants-evaluation-of-feasibility-in-a-phase-ii-study
#2
Ingrid Hansen-Pupp, Ann Hellström, Mohamed Hamdani, Adina Tocoian, Nerissa C Kreher, David Ley, Boubou Hallberg
OBJECTIVE: To evaluate the feasibility of continuous longitudinal intravenous infusion of recombinant human insulin-like growth factor-1/recombinant human insulin-like growth factor binding protein-3 (rhIGF-1/rhIGFBP-3) for prevention of retinopathy of prematurity and other complications in extremely preterm infants (<28weeks' gestational age), based on initial sections of a phase II randomized controlled trial. DESIGN: The phase II trial was designed in four sections (A-D); we report pharmacokinetic and adverse events (AEs) data pooled for Sections B and C...
August 31, 2017: Growth Hormone & IGF Research
https://www.readbyqxmd.com/read/28933971/the-pharmacokinetics-safety-and-tolerability-of-single-high-strength-doses-of-fluticasone-propionate-and-fluticasone-propionate-salmeterol-delivered-via-a-novel-multidose-dry-powder-inhaler-in-adolescents-and-adults-with-persistent-asthma
#3
Courtney Nugent, Gloria Yiu, Sharon Song, Cynthia Caracta
OBJECTIVE: Characterize fluticasone propionate (Fp) and combination fluticasone propionate and salmeterol (FS) pharmacokinetic and safety profiles, delivered via a novel, inhalation-driven, multidose dry powder inhaler (MDPI). METHODS: This multicenter, open-label, 4-period crossover, single-dose study randomized patients aged ≥12 years with persistent asthma to Fp MDPI 200 mcg, FS MDPI 200/12.5 mcg, Fp dry powder inhaler (DPI) 500 mcg (250 mcg × 2 inhalations), or FS DPI 500/50 mcg...
September 21, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/28932236/quantitative-evaluation-of-temporal-regularizers-in-compressed-sensing-dynamic-contrast-enhanced-mri-of-the-breast
#4
Dong Wang, Lori R Arlinghaus, Thomas E Yankeelov, Xiaoping Yang, David S Smith
PURPOSE: Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) is used in cancer imaging to probe tumor vascular properties. Compressed sensing (CS) theory makes it possible to recover MR images from randomly undersampled k-space data using nonlinear recovery schemes. The purpose of this paper is to quantitatively evaluate common temporal sparsity-promoting regularizers for CS DCE-MRI of the breast. METHODS: We considered five ubiquitous temporal regularizers on 4...
2017: International Journal of Biomedical Imaging
https://www.readbyqxmd.com/read/28928173/cohort-profile-of-a-study-on-outcomes-related-to-tuberculosis-and-antiretroviral-drug-concentrations-in-uganda-design-methods-and-patient-characteristics-of-the-south-study
#5
Christine Sekaggya-Wiltshire, Barbara Castelnuovo, Amrei von Braun, Joseph Musaazi, Daniel Muller, Allan Buzibye, Ursula Gutteck, Lars Henning, Bruno Ledergerber, Natascia Corti, Mohammed Lamorde, Jan Fehr, Andrew Kambugu
PURPOSE: Tuberculosis (TB) is a leading cause of death among people living with HIV in sub-Saharan Africa. Several factors influence the efficacy of TB treatment by leading to suboptimal drug concentrations and subsequently affecting treatment outcome. The aim of this cohort is to determine the association between anti-TB drug concentrations and TB treatment outcomes. PARTICIPANTS: Patients diagnosed with new pulmonary TB at the integrated TB-HIV outpatient clinic in Kampala, Uganda, were enrolled into the study and started on first-line anti-TB treatment...
September 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28928162/therapeutic-drug-monitoring-of-carboplatin-in-high-dose-protocol-ti-ce-for-advanced-germ-cell-tumors-pharmacokinetic-results-of-a-phase-2-multicenter-study
#6
Sotheara Moeung, Christine Chevreau, Sophie Broutin, Jérôme Guitton, Bénédicte Lelièvre, Joseph Ciccolini, Christophe Massard, Aude Fléchon, Rémy Delva, Gwenaëlle Gravis, Jean-Pierre Lotz, Jacques-Olivier Bay, Marine Gross-Goupil, Angelo Paci, Sabrina Marsili, Laurence Malard, Etienne Chatelut, Fabienne Thomas
PURPOSE: We aimed to evaluate the performance of therapeutic drug monitoring (TDM) approach in controlling inter-patient variability of carboplatin exposure (AUC) in patients treated with TI-CE high-dose chemotherapy for advanced germ cell tumors and to assess the possibility of using a formula-based dosing method as a possible alternative. EXPERIMENTAL DESIGN: Eighty nine patients receiving carboplatin for 3 consecutive days during 3 cycles were evaluable for pharmacokinetic study...
September 19, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28925896/allopurinol-old-drug-new-indication-in-neonates
#7
Kim V Annink, Axel R Franz, Jan B Derks, Mario Rüdiger, Frank van Bel, Manon J N L Benders
BACKGROUND: Hypoxic-ischemic encephalopathy (HIE) is an important cause of neonatal mortality and neurological morbidity, even despite hypothermia treatment. Neuronal damage in these infants is partly caused by the production of superoxides via the xanthine-oxidase pathway and concomitant free radical formation. Allopurinol is a xanthine-oxidase inhibitor and can potentially reduce the formation of these superoxides that lead to brain damage in HIE. METHODS: The aim of this review is to provide an overview of the animal and clinical data about the neuroprotective effect of allopurinol in HIE and the relevant mechanisms leading to brain injury in HIE...
September 18, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28925806/population-pharmacokinetics-of-arginine-glutamate-in-healthy-chinese-volunteers
#8
Jing Wang, Heng Zheng, Kun Wang, Zheng Wang, Yufeng Ding
1. The present study developed population pharmacokinetic models of arginine and glutamate in healthy Chinese volunteers. Two nonlinear mixed-effect models were developed using NONMEM® software (ICON Development Solutions, Ellicott City, MD) to describe the pharmacokinetic properties and to assess the relevant parameters as well as the inter-individual variability. The potential covariates were screened using stepwise approach and the stability and predictive capability of the models were performed using bootstrap and visual predictive check...
September 19, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28924743/a-physiologically-based-pharmacokinetic-model-for-pregnant-women-to-predict-the-pharmacokinetics-of-drugs-metabolized-via-several-enzymatic-pathways
#9
André Dallmann, Ibrahim Ince, Katrin Coboeken, Thomas Eissing, Georg Hempel
BACKGROUND: Physiologically based pharmacokinetic modeling is considered a valuable tool for predicting pharmacokinetic changes in pregnancy to subsequently guide in-vivo pharmacokinetic trials in pregnant women. The objective of this study was to extend and verify a previously developed physiologically based pharmacokinetic model for pregnant women for the prediction of pharmacokinetics of drugs metabolized via several cytochrome P450 enzymes. METHODS: Quantitative information on gestation-specific changes in enzyme activity available in the literature was incorporated in a pregnancy physiologically based pharmacokinetic model and the pharmacokinetics of eight drugs metabolized via one or multiple cytochrome P450 enzymes was predicted...
September 18, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28922979/a-review-of-drug-drug-interactions-in-older-hiv-infected-patients
#10
Aarthi Chary, Nancy N Nguyen, Kimberly Maiton, Mark Holodniy
The number of older HIV-infected people is growing due to increasing life expectancies resulting from the use of antiretroviral therapy (ART). Both HIV and aging increase the risk of other comorbidities, such as cardiovascular disease, osteoporosis, and some malignancies, leading to greater challenges in managing HIV with other conditions. This results in complex medication regimens with the potential for significant drug-drug interactions and increased morbidity and mortality. Area covered: We review the metabolic pathways of ART and other medications used to treat medical co-morbidities, highlight potential areas of concern for drug-drug interactions, and where feasible, suggest alternative approaches for treating these conditions as suggested from national guidelines or articles published in the English language...
September 19, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28921160/gp2013-a-rituximab-biosimilar
#11
Hannah A Blair
GP2013 is the second biosimilar of the reference monoclonal anti-CD20 antibody rituximab to be approved in the EU. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. GP2013 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA...
September 18, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28920790/pharmacokinetics-efficacy-and-safety-of-voriconazole-and-itraconazole-in-healthy-cottonmouths-agkistrodon-piscivorus-and-massasauga-rattlesnakes-sistrurus-catenatus-with-snake-fungal-disease
#12
Dana M Lindemann, Matthew C Allender, Marta Rzadkowska, Grace Archer, Lauren Kane, Eric Baitchman, Elizabeth A Driskell, Caroline T Chu, Kuldeep Singh, Shih-Hsuan Hsiao, John M Sykes, Sherry Cox
Snake fungal disease (SFD; Ophidiomyces ophiodiicola) is posing a significant threat to several free-ranging populations of pitvipers. Triazole antifungals have been proposed for the treatment of mycoses in reptiles; however, data are lacking about their safety and efficacy in snakes with SFD. Study 1 investigated in vitro susceptibility, and identified that plasma concentrations >250 ng/ml (voriconazole) and >1,000 ng/ml (itraconazole) may be effective in vivo for SFD. In Study 2, the pharmacokinetics after a single subcutaneous voriconazole injection were assessed in apparently healthy free-ranging cottonmouths (Agkistrodon piscivorus)...
September 2017: Journal of Zoo and Wildlife Medicine: Official Publication of the American Association of Zoo Veterinarians
https://www.readbyqxmd.com/read/28918602/population-pharmacokinetics-and-optimal-sampling-strategy-for-model-based-precision-dosing-of-melphalan-in-patients-undergoing-hematopoietic-stem-cell-transplantation
#13
Kana Mizuno, Min Dong, Tsuyoshi Fukuda, Sharat Chandra, Parinda A Mehta, Scott McConnell, Elias J Anaissie, Alexander A Vinks
BACKGROUND: High-dose melphalan is an important component of conditioning regimens for patients undergoing hematopoietic stem cell transplantation. The current dosing strategy based on body surface area results in a high incidence of oral mucositis and gastrointestinal and liver toxicity. Pharmacokinetically guided dosing will individualize exposure and help minimize overexposure-related toxicity. OBJECTIVE: The purpose of this study was to develop a population pharmacokinetic model and optimal sampling strategy...
September 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28918591/platform-model-describing-pharmacokinetic-properties-of-vc-mmae-antibody-drug-conjugates
#14
Matts Kågedal, Leonid Gibiansky, Jian Xu, Xin Wang, Divya Samineni, Shang-Chiung Chen, Dan Lu, Priya Agarwal, Bei Wang, Ola Saad, Neelima Koppada, Bernard M Fine, Jin Y Jin, Sandhya Girish, Chunze Li
Antibody-drug conjugates (ADCs) developed using the valine-citrulline-MMAE (vc-MMAE) platform, consist of a monoclonal antibody (mAb) covalently bound with a potent anti-mitotic toxin (MMAE) through a protease-labile vc linker. Recently, clinical data for a variety of vc-MMAE ADCs has become available. The goal of this analysis was to develop a platform model that simultaneously described antibody-conjugated MMAE (acMMAE) pharmacokinetic (PK) data from eight vc-MMAE ADCs, against different targets and tumor indications; and to assess differences and similarities of model parameters and model predictions, between different compounds...
September 16, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28915668/nsc30049-inhibits-chk1-pathway-in-5-fu-resistant-crc-bulk-and-stem-cell-populations
#15
Satya Narayan, Aruna S Jaiswal, Ritika Sharma, Akbar Nawab, Lizette Vila Duckworth, Brian K Law, Maria Zajac-Kaye, Thomas J George, Jay Sharma, Arun K Sharma, Robert A Hromas
The 5-fluorouracil (5-FU) treatment induces DNA damage and stalling of DNA replication forks. These stalled replication forks then collapse to form one sided double-strand breaks, leading to apoptosis. However, colorectal cancer (CRC) stem cells rapidly repair the stalled/collapsed replication forks and overcome treatment effects. Recent evidence suggests a critical role of checkpoint kinase 1 (Chk1) in preventing the replicative stress. Therefore, Chk1 kinase has been a target for developing mono or combination therapeutic agents...
August 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/28914978/model-informed-dose-optimization-of-dichloroacetate-for-the-treatment-of-congenital-lactic-acidosis-in-children
#16
Naveen Mangal, Margaret O James, Peter W Stacpoole, Stephan Schmidt
Dichloroacetate (DCA) is an investigational drug used to treat congenital lactic acidosis and other mitochondrial disorders. Response to DCA therapy in young children may be suboptimal following body weight-based dosing. This is because of autoinhibition of its metabolism, age-dependent changes in pharmacokinetics, and polymorphisms in glutathione transferase zeta 1 (GSTZ1), its primary metabolizing enzyme. Our objective was to predict optimal DCA doses for the treatment of congenital lactic acidosis in children...
September 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28914844/-molecular-genetic-predictors-of-resistance-to-anti-helicobacter-pylori-therapy
#17
I V Maev, D N Andreev
In current clinical practice, there is no optimal empirical therapy for Helicobacter pylori (H. pylori) infection and there is a progressive decrease in the efficiency of classical eradication therapy (ET) regimens. The variability in the efficiency of ET in a specific patient is largely due to the heterogeneous molecular genetic mechanisms underlying the resistance of the microorganism to the components of the treatment regimens. The basis of the mechanisms for antibiotic resistance in H. pylori is mainly the point mutations in some genes, which determine alterations in the mechanisms of action of drugs, such as clarithromycin (domain V of 23S rRNA), metronidazole (rdxA, frxA), amoxicillin (pbp1A), tetracycline (16S rRNA), and levofloxacin (gyrA)...
2017: Terapevticheskiĭ Arkhiv
https://www.readbyqxmd.com/read/28914344/influence-of-genetic-co-factors-on-the-population-pharmacokinetic-model-for-clopidogrel-and-its-active-thiol-metabolite
#18
Dorota Danielak, Marta Karaźniewicz-Łada, Anna Komosa, Paweł Burchardt, Maciej Lesiak, Łukasz Kruszyna, Agnieszka Graczyk-Szuster, Franciszek Główka
PURPOSE: A high interindividual variability is observed in the pharmacokinetics of clopidogrel, a widely used antiplatelet drug. In the present study, a joint parent-metabolite population pharmacokinetic model was developed to adequately describe observed concentrations of clopidogrel and its active thiol metabolite (H4). METHODS: The study included 63 patients undergoing elective coronarography or percutaneous coronary intervention. The population pharmacokinetic model was developed in the NONMEM 7...
September 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28910830/consensus-guidelines-for-therapeutic-drug-monitoring-in-neuropsychopharmacology-update-2017
#19
C Hiemke, N Bergemann, H W Clement, A Conca, J Deckert, K Domschke, G Eckermann, K Egberts, M Gerlach, C Greiner, G Gründer, E Haen, U Havemann-Reinecke, G Hefner, R Helmer, G Janssen, E Jaquenoud, G Laux, T Messer, R Mössner, M J Müller, M Paulzen, B Pfuhlmann, P Riederer, A Saria, B Schoppek, G Schoretsanitis, M Schwarz, M Silva Gracia, B Stegmann, W Steimer, J C Stingl, M Uhr, S Ulrich, S Unterecker, R Waschgler, G Zernig, G Zurek, P Baumann
Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual variability of pharmacokinetics and thus enables personalized pharmacotherapy. In psychiatry and neurology, patient populations that may particularly benefit from TDM are children and adolescents, pregnant women, elderly patients, individuals with intellectual disabilities, patients with substance abuse disorders, forensic psychiatric patients or patients with known or suspected pharmacokinetic abnormalities...
September 14, 2017: Pharmacopsychiatry
https://www.readbyqxmd.com/read/28910514/pharmacokinetics-of-single-dose-ceftaroline-fosamil-in-children-with-cystic-fibrosis
#20
Jennifer Le, John S Bradley, Sara Hingtgen, Shannon Skochko, Nanette Black, Ronald N Jones, Meerana Lim, Edmund V Capparelli
BACKGROUND: Single-dose pharmacokinetics (PK) and safety of ceftaroline fosamil with population pharmacokinetic/pharmacodynamic (PK/PD) modeling for staphylococcal pneumonia was performed in children with CF. METHODS: Subjects between 6 and 18 years old were evaluated in this phase 1, open-label, single-dose, prospective study using 10 mg/kg (up to 600 mg). Non-compartmental analysis and population-based PK analyses with Monte Carlo simulation (for doses 8-20 mg/kg every 8 h, infused over 1-4 h) were conducted...
September 14, 2017: Pediatric Pulmonology
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