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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28531881/first-in-man-dose-escalation-and-pharmacokinetic-study-of-cap7-1-a-novel-prodrug-of-etoposide-in-adults-with-refractory-solid-tumours
#1
U Keilholz, L Rohde, P Mehlitz, M Knoedler, A Schmittel, V Kümmerlen, K Klinghammer, P Treasure, M Lassus, G Steventon, M Machacek, N Utku
AIM: An open-label, phase I dose-escalation trial was performed in adult patients with various solid cancers to identify the maximum tolerated dose (MTD), to assess the safety, pharmacokinetic profile and anti-tumour activity of the new prodrug CAP7.1. The prodrug is converted to its active moiety etoposide via carboxylesterases in selective cells leading to a better tolerability and higher efficacy in therapeutic resistance cells and children with refractory neuroblastoma. PATIENTS AND METHODS: Eligible adult patients with advanced, refractory, solid malignancies received CAP7...
May 19, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28526896/signal-intensity-at-unenhanced-t1-weighted-magnetic-resonance-in-the-globus-pallidus-and-dentate-nucleus-after-serial-administrations-of-a-macrocyclic-gadolinium-based-contrast-agent-in-children
#2
Maria Camilla Rossi Espagnet, Bruno Bernardi, Luca Pasquini, Lorenzo Figà-Talamanca, Paolo Tomà, Antonio Napolitano
BACKGROUND: Few studies have been conducted on the relations between T1-weighted signal intensity changes in the pediatric brain following gadolinium-based contrast agent (GBCA) exposure. OBJECTIVE: The purpose of this study is to investigate the effect of multiple administrations of a macrocyclic GBCA on signal intensity in the globus pallidus and dentate nucleus of the pediatric brain on unenhanced T1-weighted MR images. MATERIALS AND METHODS: This retrospective study included 50 patients, mean age: 8 years (standard deviation: 4...
May 19, 2017: Pediatric Radiology
https://www.readbyqxmd.com/read/28521373/paediatric-medicines-regulatory-and-scientific-issues
#3
Chrysa Daousani, Vangelis D Karalis
In the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons...
May 18, 2017: Drug Research
https://www.readbyqxmd.com/read/28513136/cold-chain-free-storable-hydrogel-for-infant-friendly-oral-delivery-of-amoxicillin-for-the-treatment-of-pneumococcal-pneumonia
#4
Keming Xu, Liang Li, Mingyue Cui, Yiyuan Han, Huseyin Enis Karahan, Vincent Tak Kwong Chow, Chenjie Xu
Pneumonia is the major cause of death in children under five, particularly in developing countries. Antibiotics such as amoxicillin greatly help in mitigating this problem. However, there is lack of an infant/toddler-friendly formulation for countries with limited clean water and electricity. Here we report the development of a shear-thinning hydrogel system for the oral delivery of amoxicillin to the infant/toddler patients, without the need of clean water and refrigeration. The hydrogel formulation consists of metolose (hydroxypropyl methylcellulose) and amoxicillin...
May 17, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28510304/flip-flop-phenomenon-in-epidural-sufentanil-pharmacokinetics-a-population-study-in-children-and-infants
#5
Agnieszka Borsuk, Bogumiła Wołoszczuk-Gębicka, Alicja Bartkowska-Śniatkowska, Jowita Rosada-Kurasińska, Agnieszka Bienert, Paweł Wiczling
The aims of this study were to develop a population pharmacokinetic model of sufentanil coadministered with 0.2% ropivacaine as an epidural infusion in infants and describe the sufentanil absorption profile from epidural space. Data from 2 previously published studies were merged for analysis-20 infants aged 3-36 months receiving sufentanil as an epidural infusion and 41 children 0-17 years old receiving sufentanil as a long-term intravenous infusion. A population nonlinear mixed-effects model was built in NONMEM...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510296/pharmacokinetics-and-safety-of-single-dose-inhaled-loxapine-in-children-and-adolescents
#6
Sally Selim, Robert Riesenberg, James Cassella, Jeevan Kunta, Edward Hellriegel, Mark A Smith, Alexander A Vinks, Laura Rabinovich-Guilatt
This multisite open-label study sought to characterize the pharmacokinetics and safety of a single dose of inhaled loxapine in children and adolescents. Loxapine powder for oral inhalation was administered via a single-use handheld drug device to children and adolescents (aged 10-17 years) with any condition warranting chronic antipsychotic use. Patients were dosed according to body weight and cohort (<50 kg [n = 15], 2.5 or 5 mg; ≥50 kg [n = 15], 5 or 10 mg); the first 6 patients (cohort 1) enrolled in each weight group received the lower dose...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28509794/an-allometric-model-of-remifentanil-pharmacokinetics-and-pharmacodynamics
#7
Douglas J Eleveld, Johannes H Proost, Hugo Vereecke, Anthony R Absalom, Erik Olofsen, Jaap Vuyk, Michel M R F Struys
BACKGROUND: Pharmacokinetic and pharmacodynamic models are used to predict and explore drug infusion schemes and their resulting concentration profiles for clinical application. Our aim was to develop a pharmacokinetic-pharmacodynamic model for remifentanil that is accurate in patients with a wide range of age and weight. METHODS: Remifentanil pharmacokinetic data were obtained from three previously published studies of adults and children, one of which also contained pharmacodynamic data from adults...
June 2017: Anesthesiology
https://www.readbyqxmd.com/read/28507219/subcutaneous-golimumab-for-children-with-active-polyarticular-course-juvenile-idiopathic-arthritis-results-of-a-multicentre-double-blind-randomised-withdrawal-trial
#8
Hermine I Brunner, Nicolino Ruperto, Nikolay Tzaribachev, Gerd Horneff, Vyacheslav G Chasnyk, Violeta Panaviene, Carlos Abud-Mendoza, Andreas Reiff, Ekaterina Alexeeva, Nadina Rubio-Pérez, Vladimir Keltsev, Daniel J Kingsbury, Maria Del Rocio Maldonado Velázquez, Irina Nikishina, Earl D Silverman, Rik Joos, Elzbieta Smolewska, Márcia Bandeira, Kirsten Minden, Annet van Royen-Kerkhof, Wolfgang Emminger, Ivan Foeldvari, Bernard R Lauwerys, Flavio Sztajnbok, Keith E Gilmer, Zhenhua Xu, Jocelyn H Leu, Lilianne Kim, Sarah L Lamberth, Matthew J Loza, Daniel J Lovell, Alberto Martini
OBJECTIVE: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). METHODS: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m(2) of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo...
May 15, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28506866/non-maturational-covariates-for-dynamic-systems-pharmacology-models-in-neonates-infants-and-children-filling-the-gaps-beyond-developmental-pharmacology
#9
Karel Allegaert, Sinno H P Simons, Dick Tibboel, Elke Krekels, Catherijne Knibbe, John van den Anker
Pharmacokinetics and -dynamics show important changes throughout childhood. Studies on the different maturational processes that influence developmental pharmacology have been used to create population PK/PD models that can yield individualized pediatric drug dosages. These models were subsequently translated to semi-physiologically or physiology-based PK (PBPK) models that support predictions in pediatric patient cohorts and other special populations. Although these translational efforts are crucial, these models should be further improved towards individual patient predictions by including knowledge on non-maturational covariates...
May 12, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28503116/melatonin-pharmacology-functions-and-therapeutic-benefits
#10
REVIEW
Sylvie Tordjman, Sylvie Chokron, Richard Delorme, Annaëlle Charrier, Eric Bellissant, Nemat Jaafari, Claire Fougerou
BACKGROUND: Melatonin synchronizes central but also peripheral oscillators (fetal adrenal gland, pancreas, liver, kidney, heart, lung, fat, gut, etc.), allowing temporal organization of biological functions through circadian rhythms (24-hour cycles) in relation to periodic environmental changes and therefore adaptation of the individual to his/her internal and external environment. Measures of melatonin are considered the best peripheral indices of human circadian timing based on an internal 24-hour clock...
April 2017: Current Neuropharmacology
https://www.readbyqxmd.com/read/28495584/food-effects-in-paediatric-medicines-development-for-products-co-administered-with-food
#11
Hannah Batchelor, Ann Marie Kaukonen, Sandra Klein, Barbara Davit, Rob Ju, Robert Ternik, Tycho Heimbach, Wen Lin, Jian Wang, David Storey
A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food...
May 8, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28491900/screening-of-conventional-anticonvulsants-in-a-genetic-mouse-model-of-epilepsy
#12
Nicole A Hawkins, Lyndsey L Anderson, Tracy S Gertler, Linda Laux, Alfred L George, Jennifer A Kearney
OBJECTIVE: Epilepsy is a common neurological disorder that affects 1% of the population. Approximately, 30% of individuals with epilepsy are refractory to treatment, highlighting the need for novel therapies. Conventional anticonvulsant screening relies predominantly on induced seizure models. However, these models may not be etiologically relevant for genetic epilepsies. Mutations in SCN1A are a common cause of Dravet Syndrome, a severe epileptic encephalopathy. Dravet syndrome typically begins in infancy with seizures provoked by fever and then progresses to include afebrile pleomorphic seizure types...
May 2017: Annals of Clinical and Translational Neurology
https://www.readbyqxmd.com/read/28490206/pharmacokinetics-pharmacodynamics-and-pharmacogenetics-associated-with-nonsteroidal-anti-inflammatory-drugs-and-opioids-in-pediatric-cancer-patients
#13
Jonathan Constance, Sarah Campbell, Amit A Somani, Venkata Yellepeddi, Katie Owens, Catherine Sherwin
Advancing appropriate and adequate analgesic pharmacotherapy in pediatric patients with cancer is an area of clinical need. Few studies have been performed to evaluate the selection of an analgesic and appropriate dosing corresponding to analgesic effect among pediatric cancer patients. This review describes information related to pharmacokinetic, pharmacodynamic, and pharmacogenomic (when applicable) considerations for analgesics that are commonly used to manage pain experienced by pediatric patients with cancer...
May 11, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28483965/pharmacokinetics-of-efavirenz-in-2-3-years-old-children-a-high-dose-of-25-mg-kg-per-day
#14
Claire Pressiat, Madeleine Amorissani-Folquet, Caroline Yonaba, Jean-Marc Treluyer, Désiré Lucien Dahourou, François Eboua, Stéphane Blanche, Véronique Mea-Assande, Naïm Bouazza, Frantz Foissac, Karen Malateste, Sylvie Ouedraogo, Gabrielle Lui, Valériane Leroy, Déborah Hirt
Background: The MONOD ANRS 12206 trial was designated to assess simplification of a successful LPV-based antiretroviral treatment in young HIV-infected children using efavirenz (25 mg/kg/day) to preserve the protease inhibitors class before the age of 3. In this sub-study, EFV concentrations were measured to check the consistency of a 25 mg/kg EFV dose and to compare it with the 2016 FDA recommended dose.Methods: Fifty-two children underwent blood sampling for pharmacokinetic study at 6-month and 12-month after switching to EFV...
May 8, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28481829/a-population-pharmacokinetic-analysis-to-study-the-effect-of-therapeutic-hypothermia-on-vancomycin-disposition-in-children-resuscitated-from-cardiac-arrest
#15
Nicole R Zane, Michael D Reedy, Marc R Gastonguay, Adam S Himebauch, Evan Z Ramsey, Alexis A Topjian, Athena F Zuppa
OBJECTIVES: Limited data exist on the effects of therapeutic hypothermia on renal function and pharmacokinetics in pediatric patients after cardiac arrest. The objective was to describe the differences in vancomycin disposition in pediatric patients following cardiac arrest treated with either therapeutic hypothermia or normothermia using population pharmacokinetic modeling. DESIGN: Single-center, retrospective cohort study. SETTING: A tertiary care hospital pediatric and cardiac ICU...
May 5, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28480608/metabolomic-analysis-for-the-study-of-maturation-in-paediatrics-effect-of-confounding-factors-in-a-pilot-study
#16
María Encarnación Blanco, Oskar González, Oihane Elena Albóniga, M Luz Alonso, Rosa M Alonso
A pilot study for the investigation of the maturation grade of children has been carried out using plasma samples already analyzed in a previous pharmacokinetic study. By using a meticulous data treatment, possible confounding factors that may hinder the obtained results were identified. By doing so, it was possible to obtain enough evidence to support the feasibility of performing a larger study eluding some unwanted variability and minimizing not only the number of subjects involved but also the time and money spent on the study...
May 8, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28471911/application-of-population-pharmacokinetic-modeling-for-individualized-infliximab-dosing-strategies-in-crohn-s-disease
#17
Adam Frymoyer, Daniël R Hoekman, Travis L Piester, Tim G de Meij, Thalia Z Hummel, Marc A Benninga, Angelika Kindermann, K T Park
OBJECTIVES: The pharmacokinetics of infliximab are highly variable in children with Crohn's disease (CD), and a one-size-fits-all approach to dosing is inadequate. Model-based drug dosing can help individualize dosing strategies. We evaluated the predictive performance and clinical utility of a published population pharmacokinetic model of infliximab in children with CD. METHODS: Within a cohort of 34 children with CD who had infliximab trough concentrations measured, the pharmacokinetics of each patient was estimated in NONMEM® using a published population pharmacokinetic model...
May 3, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28470102/oct1-genetic-variants-are-associated-with-postoperative-morphine-related-adverse-effects-in-children
#18
Rajiv Balyan, Xue Zhang, Vidya Chidambaran, Lisa J Martin, Tomoyuki Mizuno, Tsuyoshi Fukuda, Alexander A Vinks, Senthilkumar Sadhasivam
AIM: Large interindividual variability in morphine pharmacokinetics (PK) could contribute to variability in morphine analgesia and adverse events. Respiratory depression (RD) and postoperative nausea and vomiting (PONV) are significant adverse drug response of intravenous morphine in the perioperative setting limiting its efficacy in achieving adequate surgical pain relief. OCT1 is a transporter in the liver that transports morphine from the bloodstream into hepatocytes. Earlier we reported association of genetic polymorphisms in OCT1 with morphine PK, and lower morphine clearance in Caucasian children as compared with African-American (AA) children...
May 4, 2017: Pharmacogenomics
https://www.readbyqxmd.com/read/28451892/oral-paricalcitol-expanding-therapeutic-options-for-pediatric-chronic-kidney-disease-patients
#19
EDITORIAL
Michael Freundlich, Carolyn L Abitbol
The complex pathophysiology of progressive chronic kidney disease (CKD) and the development of mineral and bone disorder, abbreviated as CKD-MBD, is of vital importance to a pediatric patient. Paricalcitol, the 19 nor-1,25(OH)2D2 analogue was shown to be effective and safe in the treatment of secondary hyperparathyroidism (SHPT) in adults almost two decades ago. It also significantly improved survival in dialysis patients compared to the standard calcitriol. The successful treatment of CKD-MBD in children is essential if they are to grow and survive into adulthood...
April 27, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28449393/a-phase-1-study-of-the-c-met-inhibitor-tivantinib-arq197-in-children-with-relapsed-or-refractory-solid-tumors-a-children-s-oncology-group-study-phase-1-and-pilot-consortium-trial-advl1111
#20
James I Geller, John P Perentesis, Xiaowei Liu, Charles G Minard, Rachel A Kudgus, Joel M Reid, Elizabeth Fox, Susan M Blaney, Brenda J Weigel
BACKGROUND: The c-Met receptor tyrosine kinase is dysregulated in many pediatric cancers. Tivantinib is an oral small molecule that inhibits the c-Met receptor tyrosine kinase. A phase 1 and pharmacokinetic (PK) trial evaluating tivantinib was conducted in children with relapsed/refractory solid tumors. METHODS: Oral tivantinib capsules were administered twice daily with food, continuously in 28-day cycles. Dose levels 170, 200, and 240 mg/m(2) /dose were evaluated using a rolling-six design (Part A)...
April 27, 2017: Pediatric Blood & Cancer
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