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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/27909943/simulating-different-dosing-scenarios-for-a-child-appropriate-valproate-er-formulation-in-a-new-pediatric-two-stage-dissolution-model
#1
Frank Karkossa, Antonia Krueger, Jana Urbaniak, Sandra Klein
Predictive in vitro test methods addressing the parameters relevant to drug release in the pediatric gastrointestinal tract could be an appropriate means for reducing the number of in vivo studies in children. However, dissolution models addressing the particular features of pediatric gastrointestinal physiology and typical pediatric dosing scenarios have not yet been described. The objective of the present study was to combine the knowledge on common vehicle types and properties and current information on pediatric gastrointestinal physiology to design a dissolution model that enables a biorelevant simulation of the gastrointestinal conditions in young children...
December 1, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/27909942/experiment-design-for-nonparametric-models-based-on-minimizing-bayes-risk-application-to-voriconazole-formula-see-text
#2
David S Bayard, Michael Neely
An experimental design approach is presented for individualized therapy in the special case where the prior information is specified by a nonparametric (NP) population model. Here, a NP model refers to a discrete probability model characterized by a finite set of support points and their associated weights. An important question arises as to how to best design experiments for this type of model. Many experimental design methods are based on Fisher information or other approaches originally developed for parametric models...
December 1, 2016: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/27909740/clinical-pharmacokinetics-of-magnesium-sulfate-in-the-treatment-of-children-with-severe-acute-asthma
#3
Joseph E Rower, Xiaoxi Liu, Tian Yu, Michael Mundorff, Catherine M T Sherwin, Michael D Johnson
PURPOSE: Intravenous (IV) magnesium sulfate (MgSO4) is used as adjunct therapy to treat acute asthma exacerbations. Despite its clinical use, there is a limited understanding of the disposition of magnesium in children. METHODS: To explore the pharmacokinetics (PK) of IV MgSO4 in this population, we collected retrospective data from 54 children who received IV MgSO4 for treatment of an acute asthma exacerbation at Primary Children's Hospital in Salt Lake City, UT...
December 2, 2016: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27905678/a-phase-i-ii-trial-of-at9283-a-selective-inhibitor-of-aurora-kinase-in-children-with-relapsed-or-refractory-acute-leukemia-challenges-to-run-early-phase-clinical-trials-for-children-with-leukemia
#4
B Vormoor, G J Veal, M J Griffin, A V Boddy, J Irving, L Minto, M Case, U Banerji, K E Swales, J R Tall, A S Moore, M Toguchi, G Acton, K Dyer, C Schwab, C J Harrison, J D Grainger, D Lancaster, P Kearns, D Hargrave, J Vormoor
Aurora kinases regulate mitosis and are commonly overexpressed in leukemia. This phase I/IIa study of AT9283, a multikinase inhibitor, was designed to identify maximal tolerated doses, safety, pharmacokinetics, and pharmacodynamic activity in children with relapsed/refractory acute leukemia. The trial suffered from poor recruitment and terminated early, therefore failing to identify its primary endpoints. AT9283 caused tolerable toxicity, but failed to show clinical responses. Future trials should be based on robust preclinical data that provide an indication of which patients may benefit from the experimental agent, and recruitment should be improved through international collaborations and early combination with established treatment strategies...
December 1, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27898598/pharmacokinetics-of-mycophenolic-acid-and-dose-optimization-in-children-after-intestinal-transplantation
#5
Caroline Barau, Antonio Mellos, Stéphanie Chhun, Florence Lacaille, Valérie Furlan
BACKGROUND: Mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (MPS) are now commonly used in pediatric intestinal transplantation (Tx), but to date, no clear recommendations regarding the dosing regimen have been made in this population. The aim of this study was to determine the MMF/MPS dosage required to achieve an area under the plasma concentration-time curve from 0 to 12 hours (AUC0-12) for mycophenolic acid (MPA) greater than 30 mg.h/L in children after intestinal transplantation...
November 28, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27895016/are-prophylactic-and-therapeutic-target-concentrations-different-the-case-of-lopinavir-ritonavir-or-lamivudine-administered-to-infants-for-the-prevention-of-mother-to-child-hiv-1-transmission-during-breastfeeding
#6
Frantz Foissac, Jörn Blume, Jean-Marc Tréluyer, Thorkild Tylleskär, Chipepo Kankasa, Nicolas Meda, James K Tumwine, Mandisa Singata-Madliki, Kim Harper, Silvia M Illamola, Naïm Bouazza, Nicolas Nagot, Philippe Van de Perre, Stéphane Blanche, Déborah Hirt
The ANRS 12174 trial assessed the efficacy and tolerance of LPV/r versus 3TC prophylaxis administered to breastfed infants, whose HIV-infected mothers were not on ART. In this sub-study, we assessed LPV/r and 3TC pharmacokinetics to evaluate the percentage of infants with therapeutic plasma concentrations and to discuss these data in the context of a prophylactic treatment. Infants from the South African trial site underwent blood sampling for pharmacokinetic study at week 6, 26 and 38 of life. We applied a Bayesian approach to derive the 3TC and LPV pharmacokinetic parameters based on previously published pharmacokinetic models for HIV-infected children...
November 28, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27891721/extended-half-life-pegylated-full-length-recombinant-factor-viii-for-prophylaxis-in-children-with-severe-haemophilia-a
#7
E S Mullins, O Stasyshyn, M T Alvarez-Román, D Osman, R Liesner, W Engl, M Sharkhawy, B E Abbuehl
INTRODUCTION: Primary factor VIII (FVIII) prophylaxis is the optimal treatment in children with severe haemophilia A. They are expected to benefit from extended half-life (T1/2 ) FVIII coverage by reduced infusion frequency while maintaining haemostatic efficacy. AIMS: To determine immunogenicity, pharmacokinetics (PK), efficacy, safety and quality of life of prophylaxis with a polyethylene glycol (peg)-ylated FVIII (BAX 855) based on full-length recombinant FVIII (ADVATE) in paediatric previously treated patients (PTPs) with severe haemophilia A...
November 27, 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/27891230/development-of-a-population-pharmacokinetic-model-of-prucalopride-in-children-with-functional-constipation
#8
Erno van Schaick, Marc A Benninga, Amy Levine, Mats Magnusson, Steven Troy
A recent phase 3 trial of prucalopride in children with functional constipation (SPD555-303 ClinicalTrials.gov Identifier: NCT01330381) reported negative efficacy results. Here, we developed a population pharmacokinetic (PK) model of prucalopride in children to assess prucalopride exposure in SPD555-303. An initial population PK model in children was developed based on sampled single-dose data from a phase 1 study (PRU-USA-12). This model was subsequently updated with sampled data from SPD555-303 and used to simulate plasma concentration-time profiles for children aged 6 months to 18 years who were treated once daily with prucalopride 0...
August 2016: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/27890414/developmental-neurotoxicants-in-human-milk-comparison-of-levels-and-intakes-in-three-european-countries
#9
Eliška Čechová, Martin Scheringer, Marta Seifertová, Ondřej Mikeš, Kristýna Kroupová, Jan Kuta, Joan Forns, Merete Eggesbø, Ilona Quaak, Marijke de Cock, Margot van de Bor, Henrieta Patayová, Ľubica Palkovičová Murínová, Anton Kočan
Developmental neurotoxicants (DNTs), such as methylmercury (MeHg), polychlorinated biphenyls (PCBs) and selected organochlorine pesticides (OCPs), have gained increasing interest recently due to their possible relation to developmental disorders in children, which are increasing worldwide. We analyzed levels of 14 developmental neurotoxicants in human milk samples from Slovakia (n=37), the Netherlands (n=120) and Norway (n=388). Positive identification for most target analytes was >95% in all samples. In all three countries MeHg was measured for the first time in mother milk...
November 24, 2016: Science of the Total Environment
https://www.readbyqxmd.com/read/27883269/oil-fortified-maize-porridge-increases-absorption-of-lumefantrine-in-children-with-uncomplicated-falciparum-malaria
#10
Norah Mwebaza, Markus Jerling, Lars L Gustafsson, Antero V Silva, Anton Pohanka, Celestino Obua, Paul Waako, Olof Beck, Manijeh Vafa Homann, Anna Färnert, Urban Hellgren
Artemether-lumefantrine (AL) is a first-line treatment for uncomplicated malaria. Absorption of lumefantrine (LUM) is fat-dependent, and in children intake is recommended with milk. We investigated whether oil-fortified maize porridge can be an alternative when milk is not available. In an open-label pharmacokinetic study, Ugandan children <5 years with uncomplicated Plasmodiun falciparum malaria were randomized to receive standard 6-dose AL treatment (1 tablet {20mgA/ 120mg LUM} if <15kg and 2 tablets if > 15 kg) with milk (A) or maize porridge plus oil (B)...
November 24, 2016: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/27877096/a-prospective-pilot-study-on-the-systemic-absorption-of-oral-vancomycin-in-children-with-colitis
#11
James W Antoon, Margaret Hall, Diana Metropulos, Michael J Steiner, Ravi Jhaveri, Jacob A Lohr
BACKGROUND: Oral vancomycin is used to treat refractory colitis due to Clostridium dificile infection. Traditionally, oral vancomycin was thought to not be absorbed systemically, but recent adult studies have demonstrated detectable serum levels in over half of patients with severe colitis. This has not been studied in children. OBJECTIVE: To determine the absorption of oral vancomycin and the renal safety profile of oral vancomycin in children hospitalized with colitis. METHODS: We performed a prospective, observational, pilot proof of principle study at the North Carolina Children's Hospital in patients 2 years to 18 years of age receiving oral vancomycin for the treatment of C dificile colitis...
September 2016: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/27875488/esomeprazole-fda-approval-in-children-with-gerd-exposure-matching-and-exposure-response
#12
Justin C Earp, Nitin Mehrotra, Kristina E Peters, Robert P Fiorentino, Donna Griebel, Sue Chih Lee, Andrew Mulberg, Kerstin Röhss, Marie Sandström, Amy Taylor, Christoffer W Tornøe, Erica L Wynn, Jan-Stefan Van der Walt, Christine Garnett
OBJECTIVES: FDA approval of proton-pump inhibitors for infantile GERD has been limited by intra-patient variability in the clinical assessment of GERD. For children 1-17 years old, extrapolating efficacy from adults for IV esomeprazole was accepted. The oral formulation was previously approved in children. Exposure-response and exposure matching analyses were sought to identify approvable pediatric doses. METHODS: Intragastric pH biomarker comparisons between children and adults were conducted...
November 19, 2016: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/27874250/immunosuppression-in-pediatric-liver-transplant-recipients-unique-aspects
#13
REVIEW
Miloh Tamir, Barton Andrea, Wheeler Justin, Pham Yen, Hewitt Winston, Keegan Tara, Sanchez Christine, Bulut Pinar, Goss John
Pediatric liver transplantation has experienced improved outcomes over the last 50 years. This can be attributed in part to establishing optimal use of immunosuppressive agents to achieve a balance between minimizing the risks of allograft rejection and infection. The management of immunosuppression in children is generally more complex and can be challenging when compared to the use of these agents in adult liver transplant patients. Physiologic differences in children alter the pharmacokinetics of immunosuppressive agents, which affects absorption, distribution, metabolism and drug excretion...
November 22, 2016: Liver Transplantation
https://www.readbyqxmd.com/read/27873037/the-true-distribution-volume-and-bioavailability-of-mizoribine-in-children-with-chronic-kidney-disease
#14
Takuhito Nagai, Osamu Uemura, Hisashi Kaneda, Katsumi Ushijima, Kazuhide Ohta, Yoshimitsu Gotoh, Kenichi Satomura, Masaki Shimizu, Mikiya Fujieda, Masashi Morooka, Takuji Yamada, Masayoshi Yamada, Naohiro Wada, Yukiya Hashimoto
BACKGROUND: Mizoribine (MZR) is used kidney transplant and various kidney diseases. However, few studies reported the association between pharmacokinetics and pharmacodynamics. The Pharmacokinetics Study Group for Pediatric Kidney Disease (PSPKD) used population pharmacokinetics (PPK) analysis and Bayesian analysis to investigate the usefulness of MZR. In this study, the fact that almost all MZR are excreted unchanged in urine was used to calculate its bioavailability (F) and true distribution volume (V d), and analyzed these correlation with age...
November 21, 2016: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/27870104/clinical-experience-with-daptomycin-in-pediatrics
#15
Katie C Namtu, Julianna C Crain, Allison F Messina, Juan A Dumois, David M Berman
INTRODUCTION: The management of Gram-positive infections has been complicated in recent years by the emergence of antimicrobial resistance, leaving fewer options for therapy. Daptomycin is a lipopeptide antibiotic used for the systemic treatment of Gram-positive infections and has a distinct mechanism of action, favorable side effect profile, and requires once daily dosing. Unfortunately, there is a paucity of safety, efficacy, and pharmacokinetic data in neonatal and pediatric patients...
November 21, 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/27859519/asymmetric-inner-wedge-group-sequential-tests-with-applications-to-verifying-whether-effective-drug-concentrations-are-similar-in-adults-and-children
#16
Lisa V Hampson, Roland Fisch, Linh M Van, Thomas Jaki
Extrapolating from information available on one patient group to support conclusions about another is common in clinical research. For example, the findings of clinical trials, often conducted in highly selective patient cohorts, are routinely extrapolated to wider populations by policy makers. Meanwhile, the results of adult trials may be used to support conclusions about the effects of a medicine in children. For example, if the effective concentration of a drug can be assumed to be similar in adults and children, an appropriate paediatric dosing rule may be found by 'bridging', that is, by matching the adult effective concentration...
November 8, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27855134/effects-of-ugt1a6-and-gabra1-on-standardized-valproic-acid-plasma-concentrations-and-treatment-effect-in-children-with-epilepsy-in-china
#17
Weixing Feng, Shenghui Mei, Leting Zhu, Yazhen Yu, Weili Yang, Baoqin Gao, Xiaojuan Wu, Zhigang Zhao, Fang Fang
BACKGROUND: Valproic acid (VPA) is a widely used antiepileptic drug with acceptable safety and efficacy in treating pediatric patients with various kinds of seizures. However, interindividual variations in plasma concentrations and treatment effects of patients with epilepsy treated with VPA are observed. This study aimed to evaluate the effects of various genetic variations on normalized plasma concentration of VPA (NCVPA) and the treatment response in Chinese children with epilepsy administered with VPA...
December 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27855070/pharmacokinetics-of-the-first-line-antituberculosis-drugs-in-ghanaian-children-with-tuberculosis-with-and-without-hiv-coinfection
#18
Sampson Antwi, Hongmei Yang, Anthony Enimil, Anima M Sarfo, Fizza S Gillani, Daniel Ansong, Albert Dompreh, Antoinette Orstin, Theresa Opoku, Dennis Bosumtwe, Lubbe Wiesner, Jennifer Norman, Charles A Peloquin, Awewura Kwara
Although human immunodefiency virus (HIV) coinfection is the most important risk factor for poor antituberculosis (anti-TB) treatment response, its effect on the pharmacokinetics of the first-line drugs in children is understudied. This study examined the pharmacokinetics of the four first-line anti-TB drugs in children with tuberculosis (TB) with and without HIV coinfection. Ghanaian children with TB on isoniazid, rifampin, pyrazinamide and ethambutol for at least 4 weeks had blood samples collected at pre-dose, 1, 2, 4, and 8-hours post-dose...
November 14, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27855062/safety-tolerability-and-pharmacokinetics-of-liposomal-amphotericin-b-in-immunocompromised-pediatric-patients
#19
Nita L Seibel, Aziza T Shad, Ihor Bekersky, Andreas H Groll, Corina Gonzalez, Lauren V Wood, Paul Jarosinski, Donald Buell, William W Hope, Thomas J Walsh
The safety, tolerability and pharmacokinetics of liposomal formulation of amphotericin B (L-AMB) were evaluated in 40 immunocompromised children and adolescents. The protocol was an open-label, sequential-dose-escalation, multidose pharmacokinetic study with 10 to 13 patients in each of the four dosage cohorts. Each cohort received daily dosages of 2.5, 5.0, 7.5 or 10 mg of amphotericin B in the form of L-AMB per kg of body weight. Neutropenic patients between ages 1 and 17 years were enrolled to receive empirical antifungal therapy or treatment of documented invasive fungal infections...
November 14, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27851686/gentamicin-pharmacokinetics-and-monitoring-in-pediatric-patients-with-febrile-neutropenia
#20
Sabina Bialkowski, Christine E Staatz, Julia Clark, Rachael Lawson, Stefanie Hennig
BACKGROUND: The pharmacokinetics of gentamicin in pediatric patients with febrile neutropenia is described, and the adequacy of initial dosing of once-daily gentamicin assessed at Queensland's largest Children's Hospital. METHODS: Data were retrospectively collected from all pediatrics with febrile neutropenia admitted over a 2-year period who had at least 2 gentamicin concentration-time measurements (a paired set within 1 dosing interval). Gentamicin clearance, volume of distribution, area under the concentration-time curve from 0 to 24 hours postdose (AUC0-24), and maximum concentration values were estimated with log-linear regression using each paired set...
December 2016: Therapeutic Drug Monitoring
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