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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28319603/the-path-of-interchangeability-of-biosimilars-in-pediatric-inflammatory-bowel-disease-quality-before-cost-savings
#1
Dimple Patel, K T Park
The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, conclusions about interchangeability should not be made for pediatric patients with IBD. Children affected by IBD, in particular, are a vulnerable group if automatic substitution and non-medical switching are allowed based on limited data in adult patients...
March 17, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28316003/evaluation-of-the-safety-tolerability-and-pharmacokinetics-of-gammaplex-%C3%A2-10-versus-gammaplex-%C3%A2-5-in-subjects-with-primary-immunodeficiency
#2
Richard L Wasserman, Isaac R Melamed, Mark R Stein, Stephen Jolles, Miranda Norton, James N Moy
PURPOSE: This phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 children with primary immunodeficiency diseases (PIDs). METHODS: Eligible adults received five Gammaplex 5% infusions followed by five Gammaplex 10% infusions, or vice versa, stratified by a 21- or 28-day dosing regimen...
March 18, 2017: Journal of Clinical Immunology
https://www.readbyqxmd.com/read/28303006/short-course-high-dose-rifampicin-achieves-wolbachia-depletion-predictive-of-curative-outcomes-in-preclinical-models-of-lymphatic-filariasis-and-onchocerciasis
#3
Ghaith Aljayyoussi, Hayley E Tyrer, Louise Ford, Hanna Sjoberg, Nicolas Pionnier, David Waterhouse, Jill Davies, Joanne Gamble, Haelly Metugene, Darren A N Cook, Andrew Steven, Raman Sharma, Ana F Guimaraes, Rachel H Clare, Andrew Cassidy, Kelly L Johnston, Laura Myhill, Laura Hayward, Samuel Wanji, Joseph D Turner, Mark J Taylor, Stephen A Ward
Lymphatic filariasis (LF) and onchocerciasis are priority neglected tropical diseases targeted for elimination. The only safe drug treatment with substantial curative activity against the filarial nematodes responsible for LF (Brugia malayi, Wuchereria bancrofti) or onchocerciasis (Onchocerca volvulus) is doxycycline. The target of doxycycline is the essential endosymbiont, Wolbachia. Four to six weeks doxycycline therapy achieves >90% depletion of Wolbachia in worm tissues leading to blockade of embryogenesis, adult sterility and premature death 18-24 months post-treatment...
March 16, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28302350/primary-prophylaxis-in-haemophilia-care-guideline-update-2016
#4
Kathelijn Fischer, Rolf Ljung
This paper reviews the current status on recommendations or guidelines for primary prophylaxis based on recent published papers from organizations or group of experts as well as some original key papers. A rather uniform view exists that prophylaxis should be initiated at an early age before or after no more than a single joint bleed and, if possible, preferably be continued for life. The dose and dose frequency of prophylaxis is dependent on the goal of treatment, bleeding phenotype, compliance, venous access and economic resources in the health care system and should be tailored individually based on clinical outcome and pharmacokinetics...
February 17, 2017: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/28296824/multicentric-case-control-study-on-azathioprine-dose-and-pharmacokinetics-in-early-onset-pediatric-inflammatory-bowel-disease
#5
Gabriele Stocco, Stefano Martelossi, Serena Arrigo, Arrigo Barabino, Marina Aloi, Massimo Martinelli, Erasmo Miele, Daniela Knafelz, Claudio Romano, Samuele Naviglio, Diego Favretto, Eva Cuzzoni, Raffaella Franca, Giuliana Decorti, Alessandro Ventura
BACKGROUND: Early-onset inflammatory bowel disease (IBD) is generally aggressive, with a high probability of complications and need of surgery. Despite the introduction of highly effective biological drugs, treatment with azathioprine continues to be important even for early-onset IBD; however, in these patients azathioprine response seems to be reduced. This study evaluated azathioprine doses, metabolite concentrations, and their associations with patients' age in children with IBD treated at 6 tertiary pediatric referral centers...
April 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28295989/pharmacokinetics-of-two-6-mercaptopurine-liquid-formulations-in-children-with-acute-lymphoblastic-leukemia
#6
Jaszianne A Tolbert, Shasha Bai, Susan M Abdel-Rahman, Keith J August, Scott J Weir, Gregory L Kearns, Kathleen A Neville
BACKGROUND: A liquid formulation of 6-mercaptopurine (6-MP) was recently approved by the Food and Drug Administration (Purixan®) based on bioavailability (BA) data from healthy adults. We examined the pharmacokinetics (PK) and BA of 6-MP in children with acute lymphoblastic leukemia (ALL) comparing a marketed tablet, two extemporaneously prepared liquid formulations, and data from the approved liquid formulation. METHODS: Twenty-two children (6-17 years) participated in a randomized two-way, crossover study of two cohorts...
March 10, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28293101/new-developments-in-the-management-of-partial-onset-epilepsy-role-of-brivaracetam
#7
REVIEW
Giangennaro Coppola, Giulia Iapadre, Francesca Felicia Operto, Alberto Verrotti
Currently, a number of novel anticonvulsant drugs, the so-called third generation, are in various stages of development. Several of them are already available or in ongoing clinical trials. These new compounds should take advantage of new insights into the basic pathophysiology of epileptogenesis, drug metabolism and drug interactions. Many of them still need to be further evaluated mainly in real-world observational trials and registries. Among newer anticonvulsant drugs for partial-onset seizures (POSs), rufinamide, lacosamide, eslicarbazepine and perampanel are those new treatment options for which more substantial clinical evidence is currently available, both in adults and, to some extent, in children...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28290120/development-of-a-pediatric-physiologically-based-pharmacokinetic-model-of-clindamycin-using-opportunistic-pharmacokinetic-data
#8
Christoph P Hornik, Huali Wu, Andrea N Edginton, Kevin Watt, Michael Cohen-Wolkowiez, Daniel Gonzalez
Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool used to characterize maturational changes in drug disposition to inform dosing across childhood; however, its use is limited in pediatric drug development. Access to pediatric pharmacokinetic data is a barrier to widespread application of this model, which impedes its development and optimization. To support the development of a pediatric PBPK model, we sought to leverage opportunistically-collected plasma concentrations of the commonly used antibiotic clindamycin...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28289025/age-weight-and-cyp2d6-genotype-are-major-determinants-of-primaquine-pharmacokinetics-in-african-children
#9
Bronner P Gonçalves, Helmi Pett, Alfred B Tiono, Daryl Murry, Sodiomon Sirima, Mikko Niemi, Teun Bousema, Chris Drakeley, Rob Ter Heine
Low dose primaquine is recommended to prevent Plasmodium falciparum malaria transmission in areas threatened by artemisinin resistance and areas aiming for malaria elimination. Community treatment campaigns with artemisinin-based combination therapy in combination with the gametocytocidal primaquine dose target all age groups but no studies thus far have assessed the pharmacokinetics of this gametocytocidal drug in African children. We recruited forty children participating in a primaquine efficacy trial in Burkina Faso to study primaquine pharmacokinetics...
March 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28280887/brivaracetam-population-pharmacokinetics-in-children-with-epilepsy-aged-1%C3%A2-month-to-16%C3%A2-years
#10
Rik Schoemaker, Janet R Wade, Armel Stockis
PURPOSE: The aims of the study were to develop a population pharmacokinetic model of orally administered brivaracetam in paediatric patients and to provide dosing suggestions. METHODS: Analysis included 600 brivaracetam plasma concentrations from a phase 2a study (NCT00422422; N01263) in 96 paediatric patients with epilepsy aged 1 month to 16 years, taking one to three concomitant antiepileptic drugs (AEDs). Pharmacokinetic analysis was performed using non-linear mixed effects modelling, and a stepwise covariate search was used to determine factors influencing brivaracetam clearance...
March 9, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28276537/recombinant-von-willebrand-factor-a-first-of-its-kind-product-for-von-willebrand-disease
#11
M Singal, P A Kouides
von Willebrand disease (VWD) is caused by quantitative or qualitative defects in von Willebrand factor (VWF). The mainstay of therapy is desmopressin, which is, however, not useful in certain forms of VWD notwithstanding adverse events. For these patients, plasma-derived factor VIII (pdFVIII)/VWF concentrates have been available for close to three decades but have a theoretical risk of disease transmission, hypersensitivity/allergic reactions, inhibitors and thrombosis. A recombinant VWF (vonicog alfa, Vonvendi™; manufactured by Baxalta, now part of Shire) was approved by the U...
December 2016: Drugs of Today
https://www.readbyqxmd.com/read/28274234/efficacy-safety-and-population-pharmacokinetics-of-sapropterin-in-pku-patients-4%C3%A2-years-results-from-the-spark-open-label-multicentre-randomized-phase-iiib-trial
#12
Ania C Muntau, Alberto Burlina, François Eyskens, Peter Freisinger, Corinne De Laet, Vincenzo Leuzzi, Frank Rutsch, H Serap Sivri, Suresh Vijay, Milva Orquidea Bal, Gwendolyn Gramer, Renata Pazdírková, Maureen Cleary, Amelie S Lotz-Havla, Alain Munafo, Diane R Mould, Flavie Moreau-Stucker, Daniela Rogoff
BACKGROUND: Sapropterin dihydrochloride, a synthetic formulation of BH4, the cofactor for phenylalanine hydroxylase (PAH, EC 1.14.16.1), was initially approved in Europe only for patients ≥4 years with BH4-responsive phenylketonuria. The aim of the SPARK (Safety Paediatric efficAcy phaRmacokinetic with Kuvan®) trial was to assess the efficacy (improvement in daily phenylalanine tolerance, neuromotor development and growth parameters), safety and pharmacokinetics of sapropterin dihydrochloride in children <4 years...
March 9, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28266713/personalised-dosing-of-medicines-for-children
#13
REVIEW
Basma Al-Metwali, Hussain Mulla
OBJECTIVES: Doses for most drugs are determined from population-level information, resulting in a standard ?one-size-fits-all' dose range for all individuals. This review explores how doses can be personalised through the use of the individuals' pharmacokinetic (PK)-pharmacodynamic (PD) profile, its particular application in children, and therapy areas where such approaches have made inroads. KEY FINDINGS: The Bayesian forecasting approach, based on population PK/PD models that account for variability in exposure and response, is a potent method for personalising drug therapy...
March 7, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28264021/antimicrobial-use-in-paediatric-patients-in-a-teaching-hospital-in-ethiopia
#14
Hafte Kahsay Kebede, Hailay Abrha Gesesew, Tewodros Eyob Woldehaimanot, Kabaye Kumela Goro
BACKGROUND: Antibiotics use in in children are different from adults due to a lack of data on pharmacokinetics, pharmacodynamics, efficacy and safety of drugs, different physiological spectrum, pediatrics populations being vulnerable to the majority of the illnesses, and the adverse effect of their irrational use is more serious. However, antibiotic use is not explored much in a paediatric population. The current study focused on antibiotic use among pediatric population using data from a tertiary hospital in Ethiopia...
2017: PloS One
https://www.readbyqxmd.com/read/28258632/methylprednisolone-aceponate-for-atopic-dermatitis
#15
Antonio Torrelo
BACKGROUND: The 4th generation topical corticosteroids (TCS) have demonstrated a most favorablerisk-benefit ratio. Methylprednisolone aceponate (MPA) is a non-halogenated corticosteroid with a methyl group at C6, which confers higher intrinsic activity. MPA is included in the group of potent TCS (category III/IV). METHODS: A literature review is carried out of the clinical efficacy, pharmacokinetics, and adverse effects of MPA, especially for the treatment of atopic dermatitis (AD)...
March 4, 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/28250007/population-pharmacokinetics-of-intravenous-erwinia-asparaginase-in-pediatric-acute-lymphoblastic-leukemia-patients
#16
Sebastiaan D T Sassen, Ron A A Mathôt, Rob Pieters, Robin Q H Kloos, Valérie de Haas, Gertjan J L Kaspers, Cor van den Bos, Wim J E Tissing, Maroeska Te Loo, Marc B Bierings, Wouter J W Kollen, Christian M Zwaan, Inge M van der Sluis
Erwinia asparaginase is an important component in the treatment of pediatric acute lymphoblastic leukemia. A large variability in serum concentrations has been observed after intravenous Erwinia asparaginase. Currently, Dutch Childhood Oncology Group protocols dose alterations are based on trough concentrations to ensure adequate asparaginase activity (≥100 IU/L). The aim of this study was to describe the population pharmacokinetics of intravenous Erwinia asparaginase to quantify and gather insight into inter-individual and inter-occasion variability...
March 2017: Haematologica
https://www.readbyqxmd.com/read/28248836/pediatric-multiple-organ-dysfunction-syndrome-promising-therapies
#17
Allan Doctor, Jerry Zimmerman, Michael Agus, Surender Rajasekaran, Juliane Bubeck Wardenburg, James Fortenberry, Anne Zajicek, Emma Mairson, Katri Typpo
OBJECTIVE: To describe the state of the science, identify knowledge gaps, and offer potential future research questions regarding promising therapies for children with multiple organ dysfunction syndrome presented during the Eunice Kennedy Shriver National Institute of Child Health and Human Development Workshop on Pediatric Multiple Organ Dysfunction Syndrome (March 26-27, 2015). DATA SOURCES: Literature review, research data, and expert opinion. STUDY SELECTION: Not applicable...
March 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28245519/pharmacokinetics-of-tranexamic-acid-in-neonates-and-infants-undergoing-cardiac-surgery
#18
Ralph Gertler, Michael Gruber, Stanislas Grassin-Delyle, Saïk Urien, Klaus Martin, Peter Tassani-Prell, Siegmund Braun, Simon Burg, Gunther Wiesner
AIM: Tranexamic acid (TXA) continues to be one of the antifibrinolytics of choice during paediatric cardiac surgery. However, in infants less than one year of age, the optimal dosing based on pharmacokinetic (PK) considerations is still under discussion. METHODS: 43 children less than one year of age were enrolled. 37 required the use of cardiopulmonary bypass (CPB) while 6 were operated on without CPB. 50 mg kg(-1) TXA i.v. at the induction of anaesthesia was followed by 50 mg kg(-1) into the CPB prime in the CPB group...
February 28, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28244808/cyp2d6-pharmacogenetic-and-oxycodone-pharmacokinetic-association-study-in-pediatric-surgical-patients
#19
Rajiv Balyan, Marc Mecoli, Raja Venkatasubramanian, Vidya Chidambaran, Nichole Kamos, Smokey Clay, David L Moore, Jagroop Mavi, Chris D Glover, Peter Szmuk, Alexander Vinks, Senthilkumar Sadhasivam
AIM: Oxycodone is partly metabolized to the active metabolite oxymorphone by hepatic CYP2D6 in the liver. Significant genetic variability in CYP2D6 activity affects oxymorphone formation. This study aimed to associate CYP2D6 genotype and oxycodone's metabolism. METHODS: 30 children were administered oral oxycodone postoperatively. Plasma levels of oxycodone and oxymorphone, and CYP2D6 genotype were analyzed. CYP2D6 genotype and oxycodone metabolism phenotype were determined based on CYP2D6 total activity score (TAS) and metabolism phenotype: poor metabolizer (PM), intermediate metabolizer (IM), extensive metabolizer (EM) or ultrarapid metabolizer (UM)...
March 2017: Pharmacogenomics
https://www.readbyqxmd.com/read/28237000/dose-estimation-in-pediatric-nuclear-medicine
#20
REVIEW
Frederic H Fahey, Alison B Goodkind, Donika Plyku, Kitiwat Khamwan, Shannon E O'Reilly, Xinhua Cao, Eric C Frey, Ye Li, Wesley E Bolch, George Sgouros, S Ted Treves
The practice of nuclear medicine in children is well established for imaging practically all physiologic systems but particularly in the fields of oncology, neurology, urology, and orthopedics. Pediatric nuclear medicine yields images of physiologic and molecular processes that can provide essential diagnostic information to the clinician. However, nuclear medicine involves the administration of radiopharmaceuticals that expose the patient to ionizing radiation and children are thought to be at a higher risk for adverse effects from radiation exposure than adults...
March 2017: Seminars in Nuclear Medicine
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