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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28720346/pharmacokinetic-data-reduce-uncertainty-in-the-acceptable-daily-intake-for-benzoic-acid-and-its-salts
#1
K Zu, D M Pizzurro, T A Lewandowski, J E Goodman
The current acceptable daily intake (ADI) for benzoic acid and its salts as food additives is 0-5 mg/kg bw-day. This accounts for a total uncertainty factor (UF) of 100, which includes a default factor of 10 for interspecies differences. Based on pharmacokinetic data in rodents and humans, we derived a chemical-specific adjustment factor (CSAF) of 2 for the pharmacokinetic component of the interspecies UF. Additional analyses indicate that this CSAF is conservative and interspecies differences between rats and humans are likely closer to unity...
July 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28719501/evaluation-of-the-adequacy-of-the-2010-revised-world-health-organization-recommended-dosages-of-the-first-line-antituberculosis-drugs-for-children
#2
Hongmei Yang, Anthony Enimil, Fizza S Gillani, Sampson Antwi, Albert Dompreh, Antoinette Ortsin, Eugene Adu Awhireng, Maxwell Owusu, Lubbe Wiesner, Charles A Peloquin, Awewura Kwara
BACKGROUND: The World Health Organization recommended increased dosages of the first-line antituberculosis (anti-TB) drugs for children in 2010. We examined the frequency of and factors associated with low plasma maximum concentration (Cmax) of each drug in children treated with the revised dosages. METHODS: Children on anti-TB therapy for at least 4 weeks underwent pharmacokinetic testing. Plasma Cmax below the lower limit of proposed reference range was considered low...
July 14, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28718515/impact-of-single-nucleotide-polymorphisms-on-plasma-concentrations-of-efavirenz-and-lopinavir-ritonavir-in-chinese-children-infected-with-the-human-immunodeficiency-virus
#3
Xia Liu, Qing Ma, Yan Zhao, Weiwei Mu, Xin Sun, Yuewu Cheng, Huiping Zhang, Ye Ma, Fujie Zhang
Single-nucleotide polymorphisms (SNPs) in the genes that encode the cytochrome P450 (CYP) drug metabolizing enzymes and drug transporters have been reported to influence antiretroviral drug pharmacokinetics. While primarily metabolized by CYP2B6 and -3A, efavirenz (EFV) and lopinavir/ritonavir (LPV/r) are substrates of P-glycoprotein and solute carrier organic (SLCO) anion transporter, respectively OBJECTIVE: To investigate the association between SNPs and efavirenz (EFV) or lopinavir/ritonavir (LPV/r) concentrations in Chinese children infected with the human immunodeficiency virus (HIV) METHODS: Genotyping was performed on CYP2B6 516G→T, -1459C→T, and -983T→C, ABCB1 3435C→T, and SLCO1B1 521T→C in 229 HIV-infected Chinese pediatric patients with an age range from 4...
July 17, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28715810/population-pharmacokinetics-of-diazoxide-in-children-with-hyperinsulinemic-hypoglycemia
#4
Rika Kizu, Kazuko Nishimura, Reiko Sato, Kenjiro Kosaki, Toshiaki Tanaka, Yusuke Tanigawara, Tomonobu Hasegawa
BACKGROUND: Diazoxide is the first-line treatment for pediatric hyperinsulinemic hypoglycemia (HI). This study aimed to elucidate the pharmacokinetics of diazoxide in children with HI. METHODS: We obtained 81 blood samples from 22 children with HI. Measured serum diazoxide concentrations were used for population pharmacokinetic analysis. Patient factors influencing pharmacokinetics were estimated using nonlinear mixed-effects model analysis. Relationships between drug exposure and adverse drug reactions were also investigated...
July 14, 2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28715785/prenatal-exposure-estimation-of-bpa-and-dehp-using-integrated-external-and-internal-dosimetry-a-case-study
#5
M A Martínez, J Rovira, R Prasad Sharma, M Nadal, M Schuhmacher, V Kumar
Prenatal exposure to Endocrine disruptors (EDs), such as Bisphenol A (BPA) and di (2-ethylhexyl) phthalate (DEHP), has been associated with obesity and diabetes diseases in childhood, as well as reproductive, behavioral and neurodevelopment problems. The aim of this study was to estimate the prenatal exposure to BPA and DEHP through food consumption for pregnant women living in Tarragona County (Spain). Probabilistic calculations of prenatal exposure were estimated by integrated external and internal dosimetry modelling, physiologically based pharmacokinetic (PBPK) model, using a Monte-Carlo simulation...
July 14, 2017: Environmental Research
https://www.readbyqxmd.com/read/28710878/6-mercaptopurine-modifies-cerebrospinal-fluid-t-cell-abnormalities-in-pediatric-opsoclonus-myoclonus-as-steroid-sparer
#6
Michael R Pranzatelli, Elizabeth D Tate, Tyler J Allison
The purpose was to evaluate the capacity of 6-mercaptopurine (6-MP), a known immunosuppressant, to normalize cerebrospinal fluid (CSF) lymphocyte frequencies in opsoclonus-myoclonus syndrome (OMS) and function as a steroid sparer. CSF and blood lymphocytes were immunophenotyped in 11 children with OMS (without CSF B cell expansion), using a comprehensive panel of cell surface adhesion, activation, and maturation markers by flow cytometry, and referenced to 18 pediatric controls. Drug metabolites, lymphocyte counts, and liver function tests were used clinically to monitoring therapeutic range and toxicity...
July 15, 2017: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/28706488/postnatal-maturation-of-the-glomerular-filtration-rate-in-conventional-growing-piglets-as-potential-juvenile-animal-model-for-preclinical-pharmaceutical-research
#7
Elke Gasthuys, Mathias Devreese, Joske Millecam, Stanislas Sys, Katrien Vanderperren, Joris Delanghe, Johan Vande Walle, Marjolein Heyndrickx, Siska Croubels
Adequate animal models are required to study the preclinical pharmacokinetics (PK), pharmacodynamics (PD) and safety of drugs in the pediatric subpopulation. Over the years, pigs were presented as a potential animal model, since they display a high degree of anatomical and physiological similarities with humans. To assess the suitability of piglets as a preclinical animal model for children, the ontogeny and maturation processes of several organ systems have to be unraveled and compared between both species...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28705916/biodistribution-and-dosimetry-of-18-f-meta-fluorobenzyl-guanidine-mfbg-a-first-in-human-pet-ct-imaging-study-of-patients-with-neuroendocrine-malignancies
#8
Neeta Pandit-Taskar, Pat B Zanzonico, Kevin D Staton, Jorge A Carrasquillo, Diane Reidy-Lagunes, Serge K Lyashchenko, Eva Burnazi, Hanwen Zhang, Jason S Lewis, Ronald Blasberg, Steven M Larson, Wolfgang Andreas Weber, Shakeel Modak
Introduction: Iodine-123-meta-iodobenzylguanidine ((123)I-MIBG) imaging is currently a mainstay in the evaluation of many neuroendocrine tumors, especially neuroblastoma. (123)I-MIBG imaging has several limitations that can be overcome by the use of a PET agent. (18)F-MFBG is a positron emission tomography (PET) analog of MIBG that may allow for single-day, high-resolution quantitative imaging. We conducted a first-in-human study of (18)F-MFBG PET imaging to evaluate the safety, feasibility, pharmacokinetics, and dosimetry of (18)F-MFBG in neuroendocrine tumors (NETs)...
July 13, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28700449/development-of-a-simple-and-rapid-method-to-measure-free-fraction-of-valproic-acid-in-plasma-using-ultrafiltration-and-uhplc-ms-application-to-therapeutic-drug-monitoring
#9
Shansen Xu, Yanan Chen, Mingming Zhao, Limei Zhao
BACKGROUND: Valproic acid (VPA) is widely used as an antiepileptic drug in children, and it is usually co-administered with other antiepileptic drugs. Due to its narrow therapeutic range and large variations in pharmacokinetic/pharmacodynamic behavior in different individuals, therapeutic drug monitoring (TDM) of the trough total VPA concentration is commonly used to guide dosing. However, as only the free fraction of VPA that exerts pharmacological and toxic effects, it may be more meaningful to determine the unbound VPA concentration in plasma...
July 8, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28693359/coagulation-monitoring-correlation-with-heparin-dose-in-pediatric-extracorporeal-life-support
#10
Katie Moynihan, Kerry Johnson, Lahn Straney, Christian Stocker, Ben Anderson, Prem Venugopal, John Roy
OBJECTIVES: Extracorporeal Life Support (ECLS) risks thrombotic and hemorrhagic complications. Optimal anti-coagulation monitoring is controversial. We compared coagulation tests evaluating the heparin effect in pediatric ECLS. METHODS: A retrospective study of children (<18yrs) undergoing ECLS over 12 months in a tertiary pediatric intensive care unit (PICU). Variables included anti-Factor Xa activity (anti-Xa), activated partial thromboplastin time (aPTT), activated clotting time (ACT) and thromboelastogram (TEG(®)6s) parameters: ratio and delta reaction (R) times (the ratio and difference, respectively, between R times in kaolin assays with and without heparinase)...
July 1, 2017: Perfusion
https://www.readbyqxmd.com/read/28692842/pk-driven-prophylaxis-versus-standard-prophylaxis-when-a-tailored-treatment-may-be-a-real-and-achievable-cost-saving-approach-in-children-with-severe-hemophilia-a
#11
Samantha Pasca, Marta Milan, Lucia Sarolo, Ezio Zanon
BACKGROUND: Prophylaxis is the gold standard for the treatment of children with severe hemophilia. In the last years a new approach to prophylaxis based on annual bleeding rate (ABR), pharmacokinetics (PK) and lifestyle of each patient has begun to be adopted in hemophilia treatment. AIM: Aim of our observational retrospective study was to evaluate whether in a group of children with severe hemophilia A (HA) a tailored approach may be used to replace standard therapy, reducing costs...
July 5, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/28692448/the-use-of-biosimilars-in-paediatric-inflammatory-bowel-disease
#12
Maria Myrthe Elisabeth Jongsma, Arnold Vulto, Lissy de Ridder
PURPOSE OF REVIEW: After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists...
July 7, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28692108/safety-and-efficacy-of-a-glycopegylated-rfviii-turoctocog-alpha-pegol-n8-gp-in-paediatric-patients-with-severe-haemophilia-a
#13
Sandrine Meunier, Jayanthi Alamelu, Silke Ehrenforth, Hideji Hanabusa, Faraizah Abdul Karim, Kaan Kavakli, Melanie Khodaie, Janice Staber, Oleksandra Stasyshyn, Donald L Yee, Lina Rageliene
Turoctocog alfa pegol (N8-GP, Novo Nordisk, Bagsværd, Denmark), an extended half-life glycoPEGylated recombinant factor VIII (rFVIII), is being developed for prophylaxis and treatment of bleeds in haemophilia A patients. pathfinder™5 is a multinational, open-label, single-arm trial to assess safety, efficacy and pharmacokinetics of N8-GP in paediatric (<12 years), previously treated patients. Boys with severe haemophilia A (<1 % FVIII), no history of inhibitors and previously treated with FVIII products (>50 exposure days [ED] for patients aged 0-5 years [younger cohort]; >150 ED for patients aged 6-11 years [older cohort]) were included...
July 6, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/28688027/pharmacokinetics-of-fentanyl-and-its-derivatives-in-children-a-comprehensive-review
#14
REVIEW
Victoria C Ziesenitz, Janelle D Vaughns, Gilbert Koch, Gerd Mikus, Johannes N van den Anker
Fentanyl and its derivatives sufentanil, alfentanil, and remifentanil are potent opioids. A comprehensive review of the use of fentanyl and its derivatives in the pediatric population was performed using the National Library of Medicine PubMed. Studies were included if they contained original pharmacokinetic parameters or models using established routes of administration in patients younger than 18 years of age. Of 372 retrieved articles, 44 eligible pharmacokinetic studies contained data of 821 patients younger than 18 years of age, including more than 46 preterm infants, 64 full-term neonates, 115 infants/toddlers, 188 children, and 28 adolescents...
July 7, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28684371/pharmacokinetics-and-model-based-dosing-to-optimize-fludarabine-therapy-in-pediatric-hematopoietic-cell-transplant-recipients
#15
Vijay Ivaturi, Christopher C Dvorak, Danna Chan, Tao Liu, Morton J Cowan, Justin Wahlstrom, Melisa Stricherz, Cathryn Jennissen, Paul J Orchard, Jakub Tolar, Sung-Yun Pai, Liusheng Huang, Francesca Aweeka, Janel Long-Boyle
A prospective multi-center study was conducted to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of fludarabine plasma (f-ara-a) and intracellular triphosphate (f-ara-ATP) in children undergoing hematopoietic cell transplantation (HCT) and receiving fludarabine with conditioning. Plasma and peripheral blood mononuclear cells (PBMCs) were collected over the course of therapy for quantitation of f-ara-a and f-ara-ATP. Nonlinear mixed effects modeling was used to develop the PK model, including identification of covariates impacting drug disposition...
July 3, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28681225/a-population-pharmacokinetic-model-to-predict-the-individual-starting-dose-of-tacrolimus-following-pediatric-renal-transplantation
#16
Louise M Andrews, Dennis A Hesselink, Teun van Gelder, Birgit C P Koch, Elisabeth A M Cornelissen, Roger J M Brüggemann, Ron H N van Schaik, Saskia N de Wildt, Karlien Cransberg, Brenda C M de Winter
BACKGROUND: Multiple clinical, demographic, and genetic factors affect the pharmacokinetics of tacrolimus in children, yet in daily practice, a uniform body-weight based starting dose is used. It can take weeks to reach the target tacrolimus pre-dose concentration. OBJECTIVES: The objectives of this study were to determine the pharmacokinetics of tacrolimus immediately after kidney transplantation and to find relevant parameters for dose individualization using a population pharmacokinetic analysis...
July 5, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28675686/the-challenges-of-achieving-postprandial-glucose-control-using-closed-loop-systems-in-patients-with-type-1-diabetes
#17
REVIEW
Véronique Gingras, Nadine Taleb, Amélie Roy-Fleming, Laurent Legault, Rémi Rabasa-Lhoret
For patients with type 1 diabetes, closed-loop delivery systems (CLS) combining an insulin pump, a glucose sensor and a dosing algorithm allowing a dynamic hormonal infusion have been shown to improve glucose control when compared to conventional therapy. Yet, reducing glucose excursion as well as simplification of prandial insulin doses remains a challenge. The objective of this literature review is to examine current meal-time strategies in the context of automated delivery systems in adults and children with type 1 diabetes...
July 4, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28663606/conscious-sedation-emerging-trends-in-pediatric-dentistry
#18
REVIEW
Joginder Pal Attri, Radhe Sharan, Vega Makkar, Kewal Krishan Gupta, Ranjana Khetarpal, Amar Parkash Kataria
Dental fear and anxiety is a common problem in pediatric patients. There is considerable variation in techniques used to manage them. Various sedation techniques using many different anesthetic agents have gained considerable popularity over the past few years. Children are not little adults; they differ physically, psychologically, and emotionally. The purpose of this review is to survey recent trends and concerning issues in the rapidly changing field of pediatric sedation. We will study the topic from the perspective of an anesthesiologist...
April 2017: Anesthesia, Essays and Researches
https://www.readbyqxmd.com/read/28656605/somapacitan-a-once-weekly-reversible-albumin-binding-gh-derivative-in-children-with-gh-deficiency-a-randomized-dose-escalation-trial
#19
Tadej Battelino, Michael Højby Rasmussen, Jean De Schepper, Nehama Zuckerman-Levin, Zoran Gucev, Lars Sävendahl
OBJECTIVE: To evaluate the safety, local tolerability, pharmacodynamics and pharmacokinetics of escalating single doses of once-weekly somapacitan, a reversible, albumin-binding GH derivative, versus once-daily GH in children with GH deficiency (GHD). DESIGN: Phase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244). PATIENTS: Thirty-two pre-pubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0...
June 28, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/28650363/population-pharmacokinetics-and-pharmacodynamic-target-attainment-of-vancomycin-in-neonates-on-extracorporeal-life-support
#20
Jeffrey J Cies, Wayne S Moore, Kristen Nichols, Chad A Knoderer, Dominick M Carella, Arun Chopra
OBJECTIVES: To evaluate the population pharmacokinetics and pharmacodynamic target attainment of vancomycin in neonates with a contemporary ¼-inch extracorporeal life support circuit with a Quadrox-iD Pediatric oxygenator (Maquet Cardiovascular, LLC, Wayne, NJ). DESIGN: Retrospective medical record review. SETTING: Two free-standing tertiary/quaternary pediatric children's hospitals. PATIENTS: Neonates receiving either veno-arterial or veno-venous extracorporeal life support and vancomycin for empiric or definitive therapy with resulting serum concentrations...
June 22, 2017: Pediatric Critical Care Medicine
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