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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/29150845/effect-of-sorbitol-on-the-pharmacokinetic-profile-of-lamivudine-oral-solution-in-adults-an-open-label-randomized-study
#1
Kimberly Adkison, Allen Wolstenholme, Yu Lou, Zhiping Zhang, Amy Eld, Teodora Perger, Harald Vangerow, Katy Hayward, Mark Shaefer, Cynthia McCoig
In children aged ≤4 years, the relative bioavailability of lamivudine oral solution was 37% lower than that of a tablet formulation. An open-label, 4-way crossover study was conducted in healthy adults to evaluate the effect of sorbitol, a common liquid excipient, on the pharmacokinetics of lamivudine oral solution (ClinicalTrials.gov identifier, NCT02634073). Sixteen subjects were randomized to 1 of 4 sequences consisting of 4 doses of lamivudine 300 mg (10 mg/mL) alone or with sorbitol 3.2, 10.2, or 13...
November 18, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29136343/pharmacokinetics-pharmacodynamics-and-safety-of-a-long-acting-human-growth-hormone-mod-4023-in-healthy-japanese-and-caucasian-adults
#2
William G Kramer, Michal Jaron-Mendelson, Ronit Koren, Oren Hershkovitz, Gili Hart
Daily injections of growth hormone (GH) as replacement therapy in GH-deficient (GHD) patients may cause poor compliance and inconvenience. C-terminal peptide-modified human GH (MOD-4023) has been developed for once-weekly administration in GHD adults and children. In the present study, the pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous dose of MOD-4023 were evaluated in healthy Caucasian and Japanese adults, using a phase 1 double-blind, vehicle-controlled, randomized study design...
November 14, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29136286/brompheniramine-and-chlorpheniramine-pharmacokinetics-following-single-dose-oral-administration-in-children-aged-2-to-17-years
#3
Sudam Pathirana, Shyamalie Jayawardena, Suzanne Meeves, Gary A Thompson
Two pediatric studies characterized brompheniramine and chlorpheniramine pharmacokinetics in a total of 72 subjects, aged 2 to 17 years. A single age-/weight-based oral dose, ranging from 1 to 4 mg, was administered with 2 to 6 oz of water at least 2 hours after a light breakfast. Plasma samples were obtained before and for 72 hours after dosing and analyzed using high-pressure liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were estimated using noncompartmental methods; relationships with age were assessed using linear regression...
November 14, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29135906/effect-of-age-and-allele-variants-of-cyp3a5-cyp3a4-and-por-genes-on-the-pharmacokinetics-of-cyclosporin-a-in-pediatric-renal-transplant-recipients-from-serbia
#4
Mirjana Cvetković, Maja Zivković, Maja Bundalo, Ivana Gojković, Brankica Spasojević-Dimitrijeva, Aleksandra Stanković, Mirjana Kostić
BACKGROUND: The interindividual variability of cyclosporin A (CsA) pharmacokinetics might be explained by heterogeneity in the cytochrome P450 3A (CYP3A) subfamily. Altered CYP3A enzyme activity was associated with variant allele of P450 oxidoreductase gene (POR*28). The aim of this study was to assess the impact of age, CYP3A5*3, CYP3A4*22, and POR*28 alleles on CsA pharmacokinetics in pediatric renal transplant recipients. METHODS: Renal transplant patients receiving CsA (n = 47) were genotyped for CYP3A5*3, CYP3A4*22, and POR*28...
December 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29133560/levofloxacin-population-pharmacokinetics-in-south-african-children-treated-for-multidrug-resistant-tuberculosis
#5
Paolo Denti, Anthony J Garcia-Prats, Heather R Draper, Lubbe Wiesner, Jana Winckler, Stephanie Thee, Kelly E Dooley, Rada M Savic, Helen M McIlleron, H Simon Schaaf, Anneke C Hesseling
Background: Levofloxacin is increasingly used in the treatment of multidrug-resistant tuberculosis (MDR-TB). There are limited paediatric pharmacokinetic data to inform dose selection for children.Methods: Children routinely receiving levofloxacin (250 mg adult tablets) for MDR-TB prophylaxis or disease in Cape Town, South Africa, underwent pharmacokinetic sampling following a 15 or 20 mg/kg dose, given as whole tablet(s) or crushed, orally, or by nasogastric tube. Pharmacokinetic parameters were estimated using non-linear mixed effects modelling...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29133558/pharmacokinetics-and-drug-drug-interactions-of-lopinavir-ritonavir-administered-with-first-and-second-line-antituberculosis-drugs-in-hiv-infected-children-treated-for-multidrug-resistant-tuberculosis
#6
Louvina E van der Laan, Anthony J Garcia-Prats, H Simon Schaaf, Tjokosela Tikiso, Lubbe Wiesner, Mine de Kock, Jana Winckler, Jennifer Norman, Helen McIlleron, Paolo Denti, Anneke C Hesseling
Background Lopinavir/ritonavir forms the backbone of current first-line antiretroviral regimens in young HIV-infected children. As multidrug-resistant (MDR) tuberculosis (TB) frequently occurs in young children in high-burden TB settings, it is important to identify potential interactions between MDR-TB treatment and lopinavir/ritonavir. We describe the pharmacokinetics of and potential drug-drug interactions between lopinavir/ritonavir and routine drugs used for MDR-TB treatment in HIV-infected children.Methods A combined population pharmacokinetic model was developed to jointly describe the pharmacokinetics of lopinavir and ritonavir in 32 HIV-infected children (16 on MDR-TB treatment with combinations of high-dose isoniazid, pyrazinamide, ethambutol, ethionamide, terizidone, a fluoroquinolone, and amikacin: and 16 without TB), who were established on a lopinavir/ritonavir-containing antiretroviral regimen...
November 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29127805/prenatal-contribution-of-2-2-4-4-tetrabromodiphenyl-ether-bde-47-to-total-body-burden-in-young-children
#7
Mi-Yeon Shin, Sunmi Kim, Sunggyu Lee, Hai-Joong Kim, Jeong Jae Lee, Gyuyeon Choi, Sooran Choi, Sungjoo Kim, Su Young Kim, Jeongim Park, Hyo-Bang Moon, Kyungho Choi, Sungkyoon Kim
Many scientists made estimates of the body burden of PBDEs from breastmilk and house dust. Interestingly, they have not included the prenatal contribution to the body burden in young children after birth. In order to address how the prenatal contribution is important in the risk assessment of PBDEs in infants up to five years old, we used the median measurements of BDE-47 as a model chemical in 108 neonates in Korea, and made simulations of its disposition out of body from birth to five years. During the simulation periods, the environmental exposure was considered for house dust, babyfood, breastmilk consumption, etc...
November 8, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/29123086/assessing-the-impact-of-imperfect-adherence-to-artemether-lumefantrine-on-malaria-treatment-outcomes-using-within-host-modelling
#8
Joseph D Challenger, Katia Bruxvoort, Azra C Ghani, Lucy C Okell
Artemether-lumefantrine (AL) is the most widely-recommended treatment for uncomplicated Plasmodium falciparum malaria worldwide. Its safety and efficacy have been extensively demonstrated in clinical trials; however, its performance in routine health care settings, where adherence to drug treatment is unsupervised and therefore may be suboptimal, is less well characterised. Here we develop a within-host modelling framework for estimating the effects of sub-optimal adherence to AL treatment on clinical outcomes in malaria patients...
November 9, 2017: Nature Communications
https://www.readbyqxmd.com/read/29119932/relevance-of-cyp2c9-function-in-valproate-therapy
#9
Katalin Monostory, Andrea Nagy, Katalin Toth, Tamas Budi, Adam Kiss, Mate Deri, Gabor Csukly
Genetic polymorphisms of drug metabolizing enzymes can substantially modify the pharmacokinetics of a drug and eventually its efficacy or toxicity; however, inferring a patient's drug metabolizing capacity merely from his or her genotype can lead to false prediction. Non-genetic host factors (age, sex, disease states) and environmental factors (nutrition, co-medication) can transiently alter the enzyme expression and activities resulting in genotype-phenotype mismatch. Although valproic acid is a well-tolerated anticonvulsant, pediatric patients are particularly vulnerable to valproate injury that can be partly attributed to the age-related differences in metabolic pathways...
November 9, 2017: Current Neuropharmacology
https://www.readbyqxmd.com/read/29119149/sofosbuvir-ledipasvir-fixed-dose-combination-for-treatment-of-chronic-hepatitis-c-virus-infection-in-children
#10
S A Rizza, V Nehra, Z Temesgen
The United States Food and Drug Administration recently approved sofosbuvir and the fixed-dose combination of ledipasvir/sofosbuvir for the treatment of hepatitis C virus (HCV) infection in children ages 12 to 17. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Pharmacokinetic data confirm equivalent drug exposure in this population as that found in adults during clinical trials. The efficacy and safety of these drugs has been shown in clinical trials.
August 2017: Drugs of Today
https://www.readbyqxmd.com/read/29115708/cyp3a5-genotype-and-its-impact-on-vincristine-pharmacokinetics-and-development-of-neuropathy-in-kenyan-children-with-cancer
#11
Jodi L Skiles, ChienWei Chiang, Claire H Li, Steve Martin, Ellen L Smith, Gilbert Olbara, David R Jones, Terry A Vik, Saskia Mostert, Floor Abbink, Gertjan J Kaspers, Lang Li, Festus Njuguna, Tammy J Sajdyk, Jamie L Renbarger
BACKGROUND: Vincristine (VCR) is a critical part of treatment in pediatric malignancies and is associated with dose-dependent peripheral neuropathy (vincristine-induced peripheral neuropathy [VIPN]). Our previous findings show VCR metabolism is regulated by the CYP3A5 gene. Individuals who are low CYP3A5 expressers metabolize VCR slower and experience more severe VIPN as compared to high expressers. Preliminary observations suggest that Caucasians experience more severe VIPN as compared to nonCaucasians...
November 8, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29115052/dose-selection-based-on-modeling-and-simulation-for-rivipansel-in-pediatric-patients-aged-6-to-11-years-with-sickle-cell-disease
#12
Brinda K Tammara, Lutz O Harnisch
This modeling and simulation exercise aimed to provide dosing recommendations for rivipansel phase 3 studies in children aged 6 to 11 years with sickle cell disease (SCD). Pharmacokinetic data from 109 patients aged 12 to 51 years who received rivipansel (2-40 mg/kg) in previous studies (3 phase 1, one phase 2) were integrated to build a 3-compartmental simulation model. Renal clearance simulations across the age range accounted for renal function development and postulated hyperfiltration in SCD. Simulated demographic distributions for the pediatric SCD population were used to predict concentration-time profiles from 3 dosing regimens, which were then compared against efficacious average steady-state concentrations observed in phase 2...
November 8, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29112080/%C3%AE-lactam-therapeutic-drug-management-in-the-picu
#13
Jeffrey J Cies, Wayne S Moore, Adela Enache, Arun Chopra
OBJECTIVES: To determine whether contemporary β-lactam anti-infective dosing recommendations in critically ill children achieve concentrations associated with maximal anti-infective activity. The secondary objective was to describe the microbiological and clinical outcomes associated with β-lactam therapeutic drug management. DESIGN: Electronic Medical Record Review. SETTING: A 189-bed, freestanding children's tertiary care teaching hospital in Philadelphia, PA...
November 3, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/29105801/pharmacokinetics-of-pidotimod-in-broiler-chickens-by-uhplc-ms-ms-after-oral-and-intravenous-administration
#14
Ruili Zhang, Mei Qiu, Li Zhao, Liangliang Cui, Chunyuan Wang, Jiajia Zhu, Zhihui Hao
Pidotimod is widely used in children as an immune promoter but it has not been fully evaluated in animals. Pharmacokinetics of pidotimod and its oral bioavailability have not been described in broiler chickens. We developed a simple and sensitive UHPLC-MS/MS assay for rapid determination of pidotimod levels in chicken blood. Recoveries were nearly 100% and the coefficients of accuracy and precision were minimal. Healthy broiler chickens were given 10 mg/kg pidotimod either orally or intravenously. The oral pidotimod was rapidly absorbed [time of reaching maximum concentration (tmax ) 1...
November 6, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29103924/ceftaroline-pharmacokinetics-and-pharmacodynamics-in-patients-with-cystic-fibrosis
#15
Emily E Barsky, Luis M Pereira, Keri J Sullivan, Alanna Wong, Alexander J McAdam, Gregory S Sawicki, Gregory P Priebe, Susan M Goobie
BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is a prevalent pathogen in patients with cystic fibrosis (CF) associated with increased morbidity. Ceftaroline fosamil is an intravenous (IV) cephalosporin with activity against MRSA. There are minimal data regarding dosing in the CF population. The objective of this study was to determine the pharmacokinetic and pharmacodynamic profile of IV ceftaroline in patients with CF. METHODS: We conducted a single-center prospective study of children and young adults with CF receiving ceftaroline (15mg/kg IV up to 600mg every 8h) as part of treatment for a CF pulmonary exacerbation between June 2016 and April 2017...
November 2, 2017: Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society
https://www.readbyqxmd.com/read/29099735/effect-of-pharmacogenetic-markers-of-vitamin-d-pathway-on-deferasirox-pharmacokinetics-in-children
#16
Sarah Allegra, Jessica Cusato, Silvia De Francia, Filomena Longo, Elisa Pirro, Davide Massano, Antonio Piga, Antonio D'Avolio
OBJECTIVES: Patients with β-thalassemia major have extremely low vitamin D levels, owing to reduced intestinal absorption, subicteric tint, and/or iron-induced higher pigmentation. We investigated whether some polymorphisms within the VDR, CYP24A1, CYP27B1, and GC genes could play a role in deferasirox pharmacokinetics in a cohort of pediatric patients. PATIENTS AND METHODS: Eighteen children with β-thalassemia were enrolled. Drug plasma concentrations at the end of dosing interval (Ctrough) and after 0, 2, 4, 6, and 24 h of drug administration were measured by a HPLC-UV method...
November 2, 2017: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/29098603/development-of-guanfacine-extended-release-dosing-strategies-in-children-and-adolescents-with-adhd-using-a-physiologically-based-pharmacokinetic-model-to-predict-drug-drug-interactions-with-moderate-cyp3a4-inhibitors-or-inducers
#17
Aiqun Li, Karen Yeo, Devin Welty, Haojing Rong
BACKGROUND: Guanfacine extended-release (GXR) is an orally administered, non-stimulant treatment for children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and is primarily metabolized by the 3A4 isozyme of cytochrome P450 (CYP3A4). The results of clinical pharmacokinetic (PK) studies indicate that guanfacine is sensitive to drug-drug interactions (DDIs) perpetrated by strong inhibitors and inducers of CYP3A4. OBJECTIVE: The aim was to provide guidance on the possible requirement for GXR dose adjustment in children and adolescents with ADHD by predicting DDIs following co-administration with moderate CYP3A4 inhibitors and inducers...
November 2, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/29095954/pyrazinamide-clearance-is-impaired-among-hiv-tuberculosis-patients-with-high-levels-of-systemic-immune-activation
#18
Christopher Vinnard, Shruthi Ravimohan, Neo Tamuhla, Jotam Pasipanodya, Shashikant Srivastava, Chawangwa Modongo, Nicola M Zetola, Drew Weissman, Tawanda Gumbo, Gregory P Bisson
Pyrazinamide is the main driver of sterilizing effect in the standard regimen in adults and older children, and this effect is concentration-dependent. Tuberculosis patients co-infected with human immunodeficiency virus (HIV) have an increased risk for poor tuberculosis treatment outcomes and adverse drug events. We sought to determine whether measures of systemic immune activation were related to pyrazinamide pharmacokinetics among HIV/tuberculosis patients. We conducted a prospective cohort study of pyrazinamide pharmacokinetics in HIV/tuberculosis patients in Gaborone, Botswana...
2017: PloS One
https://www.readbyqxmd.com/read/29090524/outcome-of-pediatric-patients-with-acute-lymphoblastic-leukemia-lymphoblastic-lymphoma-with-hypersensitivity-to-pegaspargase-treated-with-pegylated-erwinia-asparaginase-pegcrisantaspase-a-report-from-the-children-s-oncology-group
#19
Rachel E Rau, ZoAnn Dreyer, Mi Rim Choi, Wei Liang, Roman Skowronski, Krishna P Allamneni, Meenakshi Devidas, Elizabeth A Raetz, Peter C Adamson, Susan M Blaney, Mignon L Loh, Stephen P Hunger
BACKGROUND: Erwinia asparaginase is a Food and Drug Administration approved agent for the treatment of acute lymphoblastic leukemia (ALL) for patients who develop hypersensitivity to Escherichia coli derived asparaginases. Erwinia asparaginase is efficacious, but has a short half-life, requiring six doses to replace one dose of the most commonly used first-line asparaginase, pegaspargase, a polyethylene glycol (PEG) conjugated E. coli asparaginase. Pegcristantaspase, a recombinant PEGylated Erwinia asparaginase with improved pharmacokinetics, was developed for patients with hypersensitivity to pegaspargase...
November 1, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29077992/population-pharmacokinetics-of-exendin-9-39-and-clinical-dose-selection-in-patients-with-congenital-hyperinsulinism
#20
Chee M Ng, Fei Tang, Steven Seeholzer, Yixuan Zou, Diva D De León
AIMS: Congenital hyperinsulinism (HI) is the most common cause of persistent hypoglycaemia in infants and children. Exendin-(9-39), an inverse glucagon-like peptide 1 (GLP-1) agonist, is a novel therapeutic agent for HI that has demonstrated glucose-raising effect. We reported the first population pharmacokinetic (PopPK) model of the exendin-(9-39) in patients with HI and proposed the optimal dosing regimen for future clinical trials in neonates with HI. METHODS: 182 pharmacokinetic (PK) observations from 26 subjects in three clinical studies were included for constructing the PopPK model using FOCE with interaction method in NONMEM...
October 27, 2017: British Journal of Clinical Pharmacology
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