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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28640009/augmented-renal-clearance-using-population-based-pharmacokinetic-modeling-in-critically-ill-pediatric-patients
#1
Sean N Avedissian, Erin Bradley, Diana Zhang, John S Bradley, Lama H Nazer, Tri M Tran, Austin Nguyen, Jennifer Le
OBJECTIVES: The objectives of this study were to: 1) evaluate the prevalence of augmented renal clearance in critically ill pediatric patients using vancomycin clearance; 2) derive the pharmacokinetic model that best describes vancomycin clearance in critically ill pediatric patients; and 3) correlate vancomycin clearance with creatinine clearance estimated by modified Schwartz or Cockcroft-Gault. DESIGN: Retrospective, two-center, cohort study from 2003 to 2016...
June 20, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28639216/biocomparison-study-of-adult-and-paediatric-dose-strengths-of-the-prostacyclin-receptor-agonist-selexipag
#2
Margaux Boehler, Shirin Bruderer, Ivan Ulč, Jasper Dingemanse
BACKGROUND AND OBJECTIVES: Selexipag is an oral, non-prostanoid, selective prostacyclin receptor agonist recently marketed for the treatment of pulmonary arterial hypertension (PAH) in adults. Selexipag may also be an effective treatment in children with PAH. The aim of this study was to compare the pharmacokinetics of selexipag and its active metabolite ACT-333679 following single oral administration of one tablet of 200 µg selexipag (Treatment A) vs. 4 paediatric tablets of 50 µg (Treatment B) in healthy adult male subjects...
June 21, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28637741/the-closed-trial-clonidine-compared-with-midazolam-for-sedation-of-paediatric-patients-in-the-intensive-care-unit-study-protocol-for-a-multicentre-randomised-controlled-trial
#3
Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti, Dick Tibboel
INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28634578/neonatal-venous-thromboembolism
#4
REVIEW
Kristina M Haley
Neonates are the pediatric population at highest risk for development of venous thromboembolism (VTE), and the incidence of VTE in the neonatal population is increasing. This is especially true in the critically ill population. Several large studies indicate that the incidence of neonatal VTE is up almost threefold in the last two decades. Central lines, fluid fluctuations, sepsis, liver dysfunction, and inflammation contribute to the risk profile for VTE development in ill neonates. In addition, the neonatal hemostatic system is different from that of older children and adults...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/28631529/use-of-buccal-morphine-in-the-management-of-pain-in-children-with-life-limiting-conditions-results-of-a-laboratory-study
#5
Renée McCulloch, Mohammed Sattar, Ellen M Henderson, Majella E Lane, Myra Bluebond-Langner
BACKGROUND: Children and infants with impaired swallow or compromised enteral absorption require alternative routes for administration of analgesia. Recent clinical guidance and practice for paediatric palliative care teams, who often treat such children, supports buccal morphine sulphate as a fast acting, effective and easily administered agent for pain relief. However, a consideration of the physicochemical properties and potency of morphine would suggest that it is not a suitable candidate for delivery via the transmucosal route, raising questions about its use in children and infants...
June 1, 2017: Palliative Medicine
https://www.readbyqxmd.com/read/28618224/design-synthesis-and-structure-activity-relationship-of-tetrahydropyrido-4-3-d-pyrimidine-derivatives-as-potent-smoothened-antagonists-with-in-vivo-activity
#6
Wenfeng Lu, Yongqiang Liu, Haikuo Ma, Jiyue Zheng, Sheng Tian, Zhijian Sun, Lusong Luo, Jiajun Li, Hongjian Zhang, Zeng-Jie Yang, Xiaohu Zhang
Medulloblastoma is one of the most prevalent brain tumors in children. Aberrant hedgehog (Hh) pathway signaling is thought to be involved in the initiation and development of medulloblastoma. Vismodegib, the first FDA-approved cancer therapy based on inhibition of aberrant hedgehog signaling, targets smoothened (Smo), a G-protein coupled receptor (GPCR) central to the Hh pathway. Although vismodegib exhibits promising therapeutic efficacy in tumor treatment, concerns have been raised from its non-linear pharmacokinetic (PK) profiles at high doses partly due to low aqueous solubility...
June 15, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28605510/phase-i-study-of-oral-sonidegib-lde225-in-pediatric-brain-and-solid-tumors-and-a-phase-ii-study-in-children-and-adults-with-relapsed-medulloblastoma
#7
Mark W Kieran, Julia Chisholm, Michela Casanova, Alba A Brandes, Isabelle Aerts, Eric Bouffet, Simon Bailey, Sarah Leary, Tobey J MacDonald, Francoise Mechinaud, Kenneth J Cohen, Riccardo Riccardi, Warren Mason, Darren Hargrave, Stacey Kalambakas, Priya Deshpande, Feng Tai, Eunju Hurh, Birgit Geoerger
Background.: Sonidegib (LDE225) is a potent, selective Hedgehog (Hh) inhibitor of SMOOTHENED. This study explored the safety and pharmacokinetics (PK) of sonidegib in children with relapsed/recurrent tumors followed by a phase II trial in pediatric and adult patients with relapsed medulloblastoma (MB) to assess tumor response. Methods.: Pediatric patients aged ≥1-<18 years were included according to a Bayesian design starting at 372mg/m2 of continuous once daily oral sonidegib...
June 9, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28605170/pharmacokinetics-based-adherence-measures-for-antiretroviral-therapy-in-hiv-infected-kenyan-children
#8
Wanzhu Tu, Winstone M Nyandiko, Hai Liu, James E Slaven, Michael L Scanlon, Samuel O Ayaya, Rachel C Vreeman
BACKGROUND: Traditional medication adherence measures do not account for the pharmacokinetic (PK) properties of the drugs, potentially misrepresenting true therapeutic exposure. METHODS: In a population of HIV-infected Kenyan children on antiretroviral therapy including nevirapine (NVP), we used a one-compartment model with previously established PK parameters and Medication Event Monitoring Systems (MEMS®)-recorded dosing times to estimate the mean plasma concentration of NVP (Cp) in individual patients during 1 month of follow-up...
June 7, 2017: Journal of the International AIDS Society
https://www.readbyqxmd.com/read/28600736/blood-pressure-management-in-children-on-dialysis
#9
F Paglialonga, S Consolo, A Edefonti, G Montini
Hypertension is a leading cause of cardiovascular complications in children on dialysis. Volume overload and activation of the renin-angiotensin-aldosterone system play a major role in the pathophysiology of hypertension. The first step in managing blood pressure (BP) is the careful assessment of ambulatory BP monitoring. Volume control is essential and should start with the accurate identification of dry weight, based on a comprehensive assessment, including bioimpedance analysis and intradialytic blood volume monitoring (BVM)...
June 9, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28597037/erratum-to-population-pharmacokinetic-modelling-of-doxorubicin-and-doxorubicinol-in-children-with-cancer-is-there-a-relationship-with-cardiac-troponin-profiles
#10
Kuhan Kunarajah, Stefanie Hennig, Ross L G Norris, Michael Lobb, Bruce G Charles, Ross Pinkerton, Andrew S Moore
No abstract text is available yet for this article.
June 8, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28591025/neurocognitive-development-in-hiv-positive-children-is-correlated-with-plasma-viral-loads-in-early-childhood
#11
Valentin Weber, Daniel Radeloff, Bianca Reimers, Emilia Salzmann-Manrique, Peter Bader, Dirk Schwabe, Christoph Königs
Because of neurocognitive impairments in perinatally human immunodeficiency virus (HIV)-infected children and adolescents, this study aimed to demonstrate the effect of plasma viral loads and early initiation of sufficient combined antiretroviral therapy (cART) on neurocognitive development.In total, 14 perinatally infected HIV-positive children (median age 8.24 years [range: 6.0-16.74]) receiving lopinavir/ritonavir (LPV/r)-based ART underwent neurocognitive testing using the Wechsler Intelligence Score for Children, 4th Edition (WISC-IV)...
June 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28581691/recombinant-factor-xiii-prophylaxis-is-safe-and-effective-in-young-children-with-congenital-fxiii-a-deficiency-international-phase-3b-trial-results
#12
Bryce A Kerlin, Aida Inbal, Andrew Will, Michael Williams, May-Lill Garly, Lotte Jacobsen, Susan L Kearney
BACKGROUND: Factor XIII deficiency is a rare, severe congenital bleeding disorder. Monthly prophylaxis with recombinant factor XIII (rFXIII) has demonstrated favorable safety and efficacy in patients ≥6 years and may similarly benefit younger children. OBJECTIVE: To evaluate the long-term safety and efficacy of rFXIII in children <6 years with congenital FXIII A-subunit deficiency. PATIENTS/METHODS: Six children, who previously completed a single-dose pharmacokinetic trial of rFXIII, received 35 IU kg(-1) rFXIII every 28 (± 2) days for a minimum of 52 weeks and were evaluated for bleeding and adverse events...
June 5, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28581633/population-pharmacokinetic-analysis-of-zolmitriptan-and-its-metabolite-in-adults-and-adolescents-to-support-dose-selection-in-children-with-migraine
#13
Wangda Zhou, Jianguo Li, Bruce Birmingham, Hongmei Xu, Stefan Lillieborg, Diansong Zhou, Nidal Al-Huniti
Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist effective for the treatment of migraine. This analysis aimed to develop a population pharmacokinetic (PK) model for zolmitriptan and its active metabolite in adults and adolescents and provide appropriate dosing regimens to be used in clinical trials for children 6-11 years old. The data from a single-dose clinical study of 5.0-mg zolmitriptan nasal spray (ZNS) conducted in adult and adolescent patients with migraine between migraine attacks was applied...
June 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28579455/killing-kinetics-of-minocycline-doxycycline-and-tosufloxacin-against-macrolide-resistant-mycoplasma-pneumoniae
#14
Miyuki Morozumi, Takafumi Okada, Takeshi Tajima, Kimiko Ubukata, Satoshi Iwata
Macrolide-resistant Mycoplasma pneumoniae (MRMP) has emerged and is increasing worldwide. In a 2011 outbreak of MRMP infections in Japan, symptoms failed to improve in many patients who initially received macrolides; the therapeutic agent was then changed to minocycline (MIN), doxycycline (DOX) or tosufloxacin (TFX). In this study, the bactericidal effects of these three agents against MRMP were evaluated. Time-kill kinetics against MRMP and macrolide-susceptible M. pneumoniae (MSMP) were determined over 5 days at concentrations corresponding to the respective minimum inhibitory concentration (MIC) and 2× MIC, i...
June 1, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28578536/population-pharmacokinetic-and-exposure-response-analyses-of-prasugrel-in-pediatric-patients-with-sickle-cell-anemia
#15
Brian A Moser, Elizabeth S LaBell, Emmanuel Chigutsa, Joseph A Jakubowski, David S Small
BACKGROUND AND OBJECTIVE: Prasugrel, a P2Y12 adenosine diphosphate (ADP) receptor antagonist, inhibits ADP-mediated platelet activation and aggregation in patients with sickle cell anemia (SCA). We developed a population pharmacokinetic (popPK) model in pediatric patients from 2 to <18 years of age with SCA, and performed exposure-response evaluations to characterize the effects of prasugrel in a subset of these patients who weighed 19 kg or more and experienced at least two episodes of vaso-occlusive crises (VOC) in the past year...
June 3, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28577293/pharmacokinetics-of-bevacizumab-in-three-patients-under-the-age-of-3%C3%A2-years-with-cns-malignancies
#16
Johannes Gojo, Robert Sauermann, Ursula Knaack, Irene Slavc, Andreas Peyrl
BACKGROUND: Bevacizumab is a recombinant antibody that is increasingly used in pediatric malignancies. The pharmacokinetics of bevacizumab in pediatric patients have been shown to be influenced by tumor localization and body weight. In this report, we present data on the pharmacokinetics and safety of bevacizumab in children under the age of 3 years with central nervous system (CNS) malignancies. METHODS: Three patients (mean age 22 months) were treated with intravenous bevacizumab 10 mg/kg every 2 weeks...
June 2, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28575523/safety-and-pharmacokinetic-study-of-fidaxomicin-in-children-with-clostridium-difficile-associated-diarrhea-a-phase-2a-multicenter-clinical-trial
#17
Molly A O'Gorman, Marian G Michaels, Sheldon L Kaplan, Anthony Otley, Larry K Kociolek, Edward J Hoffenberg, Kwang Sik Kim, Sharon Nachman, Marian D Pfefferkorn, Timothy Sentongo, Janice E Sullivan, Pamela Sears
Background.: Fidaxomicin is an approved therapy for Clostridium difficile-associated diarrhea (CDAD) in adults. The safety of fidaxomicin in children has not been reported. Methods.: In this study (ClinicalTrials.gov identifier NCT01591863), pediatric patients with CDAD received twice-daily oral fidaxomicin at a dose of 16 mg/kg per day (up to 200 mg) for 10 days in an open-label study. Plasma and fecal samples were collected for pharmacokinetic assessments. The primary outcome measure was safety, which was assessed by adverse-event (AE), laboratory, and physical examination/vital-sign monitoring...
May 31, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28561203/relationship-between-daily-dose-serum-concentration-and-clinical-response-to-quetiapine-in-children-and-adolescents-with-psychotic-and-mood-disorders
#18
Laura Albantakis, Karin Egberts, Rainer Burger, Christine Kulpok, Claudia Mehler-Wex, Regina Taurines, Stefan Unterecker, Christoph Wewetzer, Marcel Romanos, Manfred Gerlach
Introduction In child and adolescent psychiatry, therapeutic drug monitoring (TDM) is strongly recommended. However, therapeutic ranges (TR) are defined only for adults. The objectives of this naturalistic study were to assess the relationships between serum quetiapine concentration, daily dose, and clinical outcomes as well as the determinants of pharmacokinetic variability. Furthermore, it was elucidated whether the recommended TR for adult patients with psychotic disorders is valid for children and adolescents...
May 23, 2017: Pharmacopsychiatry
https://www.readbyqxmd.com/read/28558308/age-predicts-cytokine-kinetics-and-innate-immune-cell-activation-following-intranasal-delivery-of-ifn%C3%AE-and-gm-csf-in-a-mouse-model-of-rsv-infection
#19
Katherine M Eichinger, Erin Resetar, Jacob Orend, Kacey Anderson, Kerry M Empey
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and is further associated with increased healthcare utilization and cost of care in the first years of life. Severe RSV disease during infancy has also been linked to the later development of allergic asthma, yet there remains no licensed RSV vaccine or effective treatment. Pre-clinical and clinical studies have shown that disease severity and development of allergic asthma are associated with differences in cytokine production...
May 27, 2017: Cytokine
https://www.readbyqxmd.com/read/28556691/t1-weighted-dynamic-contrast-enhanced-brain-magnetic-resonance-imaging-a-preliminary-study-with-low-infusion-rate-in-pediatric-patients
#20
Bruno-Bernard Rochetams, Bénédicte Marechal, Jean-Philippe Cottier, Kathleen Gaillot, Catherine Sembely-Taveau, Dominique Sirinelli, Baptiste Morel
Background The aim of this preliminary study is to evaluate the results of T1-weighted dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) in pediatric patients at 1.5T, with a low peripheral intravenous gadoteric acid injection rate of 1 ml/s. Materials and methods Children with neurological symptoms were examined prospectively with conventional MRI and T1-weighted DCE MRI. An magnetic resonance perfusion analysis method was used to obtain time-concentration curves (persistent pattern, type-I; plateau pattern, type-II; washout pattern, type-III) and to calculate pharmacokinetic parameters...
January 1, 2017: Neuroradiology Journal
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