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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28218755/changes-in-the-incidence-patterns-and-outcomes-of-graft-failure-following-hematopoietic-stem-cell-transplantation-for-hurler-syndrome
#1
S H Lum, W P Miller, S Jones, K Poulton, W Ogden, H Lee, A Logan, D Bonney, T C Lund, P J Orchard, R F Wynn
Hematopoietic stem cell transplantation (HSCT) is the standard of care in children with Hurler syndrome (HS) as it is the only therapy that can arrest disease progression. We examined the incidence, patterns and outcomes of graft failure in all HS children undergoing first HSCT at the Royal Manchester Children's Hospital or the University of Minnesota Children's Hospital from 1983 to 2016. Implementation of busulfan pharmacokinetic monitoring started in 2004 in both institutions. Two hundred and forty HS children were included in this analysis (historical era (pre-2004), n=131; current era (post 2004), n=109)...
February 20, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28213957/a-bosentan-pharmacokinetic-study-to-investigate-dosing-regimens-in-paediatric-patients-with-pulmonary-arterial-hypertension-future-3
#2
R M F Berger, M Gehin, M Beghetti, D Ivy, A Kusic-Pajic, P Cornelisse, S Grill, D Bonnet
AIM: To investigate whether increasing bosentan dosing frequency from 2 mg/kg twice daily (b.i.d.) to 2 mg/kg three times daily (t.i.d.) in children with pulmonary arterial hypertension (PAH) (from ≥3 months to <12 years of age) would increase exposure. METHODS: An open-label, prospective, randomised, multicentre, multiple-dose, Phase 3 study was conducted. Patients (n = 64) were randomised 1:1 to receive oral doses of bosentan of 2 mg/kg b.i...
February 18, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28211198/safety-of-antifibrinolytics-in-cranial-vault-reconstructive-surgery-a-report-from-the-pediatric-craniofacial-collaborative-group
#3
Susan M Goobie, Franklyn P Cladis, Chris D Glover, Henry Huang, Srijaya K Reddy, Allison M Fernandez, David Zurakowski, Paul A Stricker
BACKGROUND: Antifibrinolytic therapy significantly decreases blood loss and transfusion in pediatric cranial vault reconstructive surgery; however, concern regarding the side effects profile limits clinical use. AIMS: The aim was to utilize the Pediatric Craniofacial Surgery Perioperative Registry database to identify the safety profile of antifibrinolytic therapy for cranial vault reconstructive surgery by reporting the incidence of adverse events as they relate to exposure to tranexamic acid and aminocaproic acid compared to no exposure to antifibrinolytics...
March 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28209419/a-safety-and-pharmacokinetic-dosing-study-of-glucagon-like-peptide-2-in-infants-with-intestinal-failure
#4
David L Sigalet, Mary E Brindle, Dana Boctor, Bryan Dicken, Viona Lam, Lily Sia Lu, Elaine de Heuvel, Bolette Hartmann, Jens J Holst
BACKGROUND & AIMS: Glucagon-like peptide 2 (GLP-2) analogues are approved for adults with intestinal failure (IF), but no studies have included infants. This study examined the pharmacokinetics (PK), safety, and nutritional effects of GLP-2 in infants with IF. METHODS: With parental consent (Health Canada Protocol:150,979), parenteral nutrition (PN)-dependent infants were treated with 5-20-μg/kg/day GLP-2 for 3days (phase 1), and if tolerated continued for 42days (phase 2)...
January 29, 2017: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/28206886/guideline-for-monitoring-and-management-of-pediatric-patients-before-during-and-after-sedation-for-diagnostic-and-therapeutic-procedures-update-2016
#5
(no author information available yet)
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase thepotential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions...
October 15, 2016: Pediatric Dentistry
https://www.readbyqxmd.com/read/28205374/developmental-pharmacokinetics-of-sirolimus-implications-for-precision-dosing-in-neonates-and-infants-with-complicated-vascular-anomalies
#6
Tomoyuki Mizuno, Tsuyoshi Fukuda, Chie Emoto, Paula S Mobberley-Schuman, Adrienne M Hammill, Denise M Adams, Alexander A Vinks
BACKGROUND: Sirolimus has recently been shown to be efficacious and tolerable in pediatric patients with complicated vascular anomalies. Nevertheless, dosing information remains very limited especially for neonates and infants. The purpose of this study was to develop an age-appropriate sirolimus starting dosing regimen based on the developmental changes in drug elimination capacity using data collected in neonates and infants. PROCEDURE: A recently developed sirolimus maturation model [Emoto et al...
February 16, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#7
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28205004/maturation-of-oxycodone-pharmacokinetics-in-neonates-and-infants-a-population-pharmacokinetic-model-of-three-clinical-trials
#8
Pyry Välitalo, Merja Kokki, Veli-Pekka Ranta, Klaus T Olkkola, Andrew C Hooker, Hannu Kokki
PURPOSE: The aim of the current population pharmacokinetic study was to quantify oxycodone pharmacokinetics in children ranging from preterm neonates to children up to 7 years of age. METHODS: Data on intravenous or intramuscular oxycodone administration were obtained from three previously published studies (n = 119). The median [range] postmenstrual age of the subjects was 299 days [170 days-7.8 years]. A population pharmacokinetic model was built using 781 measurements of oxycodone plasma concentration...
February 15, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28202365/optimising-the-use-of-medicines-to-reduce-acute-kidney-injury-in-children-and-babies
#9
REVIEW
L Oni, D B Hawcutt, M A Turner, M W Beresford, S McWilliam, C Barton, B K Park, P Murray, B Wilm, I Copple, R Floyd, M Peak, A Sharma, D J Antoine
The majority of medications in children are administered in an unlicensed or off-label manner. Paediatricians are obliged to prescribe using the limited evidence available. The 2007 EU regulation on the use of paediatric drugs means pharmaceutical companies are now obliged to (and receive incentives for) contributing to paediatric drug data and carrying out paediatric clinical trials. This is important, as the efficacy and adverse effect profiles of medicines vary across childhood. Additionally, there are significant age-related changes in the pharmacodynamic and pharmacokinetic activity of many drugs...
February 12, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28186264/predictive-performance-of-eleven-pharmacokinetic-models-for-propofol-infusion-in-children-for-long-duration-anaesthesia
#10
M Hara, K Masui, D J Eleveld, M M R F Struys, O Uchida
No abstract text is available yet for this article.
February 10, 2017: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28177130/a-population-pharmacokinetic-model-of-at9283-in-adults-and-children-to-predict-the-maximum-tolerated-dose-in-children-with-leukaemia
#11
Janna K Duong, Melanie J Griffin, Darren Hargrave, Josef Vormoor, David Edwards, Alan V Boddy
AIMS: AT9283 is used to treat patients with solid tumors and patients with leukaemia. However, the maximum tolerated dose (MTD) for children with leukaemia remains unknown due to early termination of the Phase I trial. The aim of this study was to develop a population model of AT9283 to describe the pharmacokinetics in adults and children and to estimate the MTD in children with leukaemia. METHODS: Data from Phase I dose-escalation studies in adults and children were used to build a population pharmacokinetic model (NONMEM v7...
February 8, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28166608/safety-efficacy-and-pharmacokinetics-of-rviii-singlechain-in-children-with-severe-hemophilia-a-sesults-of-a-multicenter-clinical-trial
#12
Oleksandra Stasyshyn, Claudia Djambas Khayat, Genadi Iosava, Jeannie Ong, Faraizah Abdul Karim, Kathelijn Fischer, Alex Veldman, Nicole Blackman, Katie St Ledger, Ingrid Pabinger
BACKGROUND: rVIII-SingleChain, is a novel B-domain truncated recombinant Factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand Factor. OBJECTIVES: This Phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients <12 years of age with severe hemophilia A. PATIENTS/METHODS: Patients could be assigned to prophylaxis or on-demand therapy by the investigator...
February 6, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28165318/an-evaluation-approach-for-the-performance-of-dosing-regimens-in-attention-deficit-hyperactivity-disorder-treatment
#13
Guillaume Bonnefois, Philippe Robaey, Olivier Barrière, Jun Li, Fahima Nekka
OBJECTIVE: Stimulant medications, with methylphenidate as the main agent, are the most prescribed for the treatment of attention-deficit/hyperactivity disorder. Nevertheless, real challenges still remain for clinicians concerned with adaptation of the therapeutic regimens, in terms of doses and timing, to children's daily activities. The aim of this study was to optimize short-acting methylphenidate regimens according to specific children's needs by evaluating the performance of a particular regimen through a web-based application...
February 6, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28159657/dose-optimisation-of-voriconazole-with-therapeutic-drug-monitoring-in-children-a-single-centre-experience-in-china
#14
Liang Liu, Xing Zhou, Tingting Wu, Hongliang Jiang, Sitao Yang, Yang Zhang
The pharmacokinetic profile of voriconazole is highly variable, rendering inconsistent and/or inadequate dosing, especially in children <2 years old. A retrospective analysis was performed in children receiving voriconazole with at least one plasma trough level (Ctrough) monitored. Statistical analyses were performed to examine the dose-exposure relationship as well as other factors potentially affecting voriconazole Ctrough in children of different ages. A total of 107 paediatric patients were included, of whom 75 were <2 years old...
January 31, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28159192/recombinant-factor-ix-fc-fusion-protein-in-children-with-haemophilia-b-kids-b-long-results-from-a-multicentre-non-randomised-phase-3-study
#15
Kathelijn Fischer, Roshni Kulkarni, Beatrice Nolan, Johnny Mahlangu, Savita Rangarajan, Giulia Gambino, Lei Diao, Alejandra Ramirez-Santiago, Glenn F Pierce, Geoffrey Allen
BACKGROUND: Kids B-LONG was a multicentre, open-label, phase 3 study assessing the safety, efficacy, and pharmacokinetics of recombinant factor IX Fc fusion protein (rFIXFc) in previously treated paediatric patients younger than 12 years with severe haemophilia B. METHODS: The study enrolled 30 previously treated boys younger than 12 years with haemophilia B (≤2 IU/dL [≤2%] endogenous coagulation factor IX [FIX] activity). All patients were initially given rFIXFc prophylaxis (50-60 IU/kg) once per week with adjustments to dose (≤100 IU/kg per infusion) or dosing frequency (up to two times per week) as needed...
February 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28157063/safe-excipient-exposure-in-neonates-and-small-children-protocol-for-the-seen-project
#16
Kristine Svinning Valeur, Steen Axel Hertel, Kaare Engell Lundstrøm, Helle Holst
INTRODUCTION: The pharmacokinetics of excipients in neonates differs from that of older children. In a recent pan--European survey, two thirds of neonates received at least one potentially harmful excipient, such as ethanol and benzoates. The content of sweeteners varied by route of administration (more common by enteral than parenteral route), and regional differences were revealed. The survey did not identify if the content of excipients was more pronounced in medications prescribed for specific medical diseases, e...
February 2017: Danish Medical Journal
https://www.readbyqxmd.com/read/28155137/successful-use-of-14-c-paracetamol-microdosing-to-elucidate-developmental-changes-in-drug-metabolism
#17
Miriam G Mooij, Esther van Duijn, Catherijne A J Knibbe, Karel Allegaert, Albert D Windhorst, Joost van Rosmalen, N Harry Hendrikse, Dick Tibboel, Wouter H J Vaes, Saskia N de Wildt
BACKGROUND: We previously showed the practical and ethical feasibility of using [(14)C]-microdosing for pharmacokinetic studies in children. We now aimed to show that this approach can be used to elucidate developmental changes in drug metabolism, more specifically, glucuronidation and sulfation, using [(14)C]paracetamol (AAP). METHODS: Infants admitted to the intensive care unit received a single oral [(14)C]AAP microdose while receiving intravenous therapeutic AAP every 6 h...
February 2, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28137820/pharmacokinetics-of-clindamycin-in-obese-and-non-obese-children
#18
Michael J Smith, Daniel Gonzalez, Jennifer L Goldman, Ram Yogev, Janice E Sullivan, Michael D Reed, Ravinder Anand, Karen Martz, Katherine Berezny, Daniel K Benjamin, P Brian Smith, Michael Cohen-Wolkowiez, Kevin Watt
Although obesity is prevalent among children in the United States, pharmacokinetic (PK) data in obese children are limited. Clindamycin is a commonly used antibiotic that may require dose adjustment in obese children due to its lipophilic properties. We performed a clindamycin population PK analysis using data from three separate trials. A total of 420 samples from 220 children, 76 of whom had a body mass index ≥ 95(th) percentile for age, were included in the analysis. As compared to other metrics, total body weight (TBW) was the most robust measure of body size...
January 30, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28129817/-dalbavancin-pharmacokinetic-and-pharmacodynamic-parameters
#19
José Ramón Azanza, Belén Sádaba, Joana Reis
Dalbavancin is a new lipoglycopeptide antibiotic whose structure influences its pharmacokinetic profile. It is not absorbed after oral administration and is therefore administered intravenously. It is distributed through intracellular fluid, reaching adequate concentrations in the skin, bone, blister fluid and synovial fluid. Plasma protein binding is very high. Concentrations in brain tissue and cerebrospinal fluid (CSF) are inadequate. Excretion is through non-microsomal metabolism with inactive metabolites and through the kidneys by glomerular filtration...
January 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28125553/o-005-combination-therapy-with-methotrexate-does-not-change-infliximab-pharmacokinetics-in-children-with-inflammatory-bowel-disease
#20
Valentina Shakhnovich, Leon Van Haandel, Mara Becker, Ryan Funk
BACKGROUND: There remains a question of equipoise regarding the use of anti-TNF-α agent (e.g., infliximab) monotherapy versus combination therapy with immunomodulators (e.g., methotrexate), for the treatment of pediatric Inflammatory Bowel Disease (IBD). The aim of this prospective cross-sectional study was to assess the impact of methotrexate (MTX) on infliximab (IFX) pharmacokinetics (i.e., serum trough levels) and infliximab antibody (anti-IFX) formation in children with IBD. METHODS: Forty-one children with IBD (9-21 yr of age), receiving maintenance IFX infusions as part of their standard-of-medical-care, had serum IFX and anti-IFX concentrations assessed via an established NF-kB luciferase gene-reporter assay (ARUP Laboratories)...
February 2017: Inflammatory Bowel Diseases
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