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Population pharmacokinetics

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https://www.readbyqxmd.com/read/29677389/population-pharmacokinetics-of-intramuscular-and-intravenous-ketamine-in-children
#1
Christoph P Hornik, Daniel Gonzalez, John van den Anker, Andrew M Atz, Ram Yogev, Brenda B Poindexter, Kee Chong Ng, Paula Delmore, Barrie L Harper, Chiara Melloni, Andrew Lewandowski, Casey Gelber, Michael Cohen-Wolkowiez, Jan Hau Lee
Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in children undergoing invasive procedures. Available for both intravenous and intramuscular administration, ketamine is commonly used when vascular access is limited. Pharmacokinetic (PK) data in children are sparse, and the bioavailability of intramuscular ketamine in children is unknown. We performed 2 prospective PK studies of ketamine in children receiving either intramuscular or intravenous ketamine and combined the data to develop a pediatric population PK model using nonlinear mixed-effects methods...
April 20, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29673329/comparison-of-electroencephalographic-changes-in-response-to-acute-electrical-and-thermal-stimuli-with-the-tail-flick-and-hot-plate-test-in-rats-administered-with-opiorphin
#2
Preet Singh, Kavitha Kongara, David Harding, Neil Ward, Venkata Sayoji Rao Dukkipati, Craig Johnson, Paul Chambers
BACKGROUND: The objective of this study was to compare the changes in the electroencephalogram (EEG) in response to noxious stimuli with tail flick and hot plate responses of rats administered opiorphin. METHODS: Female Sprague -Dawley rats (n = 8 per group) randomly received intravenous (IV) injection of morphine (1 mg/kg,) or opiorphin (2 mg/kg,) or saline (0.5 ml,) in each of the three testing methods (EEG, tail flick and hot plate). Each type of test (n = 24 per test) was conducted in different population of rats on separate occasions...
April 19, 2018: BMC Neurology
https://www.readbyqxmd.com/read/29667720/mycophenolate-mofetil-administered-every-8-hours-in-combination-with-tacrolimus-is-efficacious-in-the-prophylaxis-of-acute-graft-versus-host-disease-in-childhood-adolescent-and-young-adult-allogeneic-stem-cell-transplantation-recipients
#3
Olga Militano, Mehmet F Ozkaynak, Brinda Mehta, Carmella van deVen, Carl Hamby, Mitchell S Cairo
BACKGROUND: The optimal dose and schedule of mycophenolate mofetil (MMF) in pediatric allogeneic stem cell transplant recipients remains to be determined. We previously reported safety and pharmacokinetics of MMF at 900 mg/m2 q6h dosing. This study was conducted to investigate the efficacy of tacrolimus plus q8h MMF dosing for acute graft versus host disease (GVHD) prophylaxis in a heterogeneous population of children, adolescent, young adult allogeneic stem cell transplant recipients, utilizing multiple allogeneic donor sources...
April 18, 2018: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29666902/effect-of-cyp2c19-ugt1a8-and-ugt2b7-on-valproic-acid-clearance-in-children-with-epilepsy-a-population-pharmacokinetic-model
#4
Shenghui Mei, Weixing Feng, Leting Zhu, Xingang Li, Yazhen Yu, Weili Yang, Baoqin Gao, Xiaojuan Wu, Fang Fang, Zhigang Zhao
PURPOSE: Valproic acid (VPA) is an important drug in seizure control with great inter-individual differences in metabolism and treatment effect. This study aims to identify the effects of genetic variants on VPA clearance in a population pharmacokinetic (popPK) model in children with epilepsy. METHODS: A total of 325 VPA plasma concentrations from 290 children with epilepsy were used to develop the popPK model by using the nonlinear mixed-effects modeling method...
April 17, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29665062/phase-1-studies-to-assess-the-safety-tolerability-and-pharmacokinetics-of-jte-052-a-novel-janus-kinase-inhibitor-ointment-in-japanese-healthy-volunteers-and-patients-with-atopic-dermatitis
#5
Hidemi Nakagawa, Osamu Nemoto, Hiroyuki Yamada, Takeshi Nagata, Noriko Ninomiya
The purpose of the present two phase 1 studies was to assess the safety, tolerability and pharmacokinetics for topical application of a novel Janus kinase (JAK) inhibitor, JTE-052, in Japanese healthy adult male volunteers and Japanese adult patients with atopic dermatitis (AD). Additionally, exploratory investigation was performed on the efficacy for disease severity and pruritus score in AD patients. In the QBX1-1 study, the cutaneous safety of JTE-052 ointment by a patch test and a photo patch test was assessed in an intra-individual comparative study using placebo ointment, white petrolatum and non-application as comparators...
April 17, 2018: Journal of Dermatology
https://www.readbyqxmd.com/read/29663428/midazolam-single-time-point-concentrations-to-estimate-exposure-and-cytochrome-p450-cyp-3a-constitutive-activity-utilizing-limited-sampling-strategy-with-a-population-pharmacokinetic-approach
#6
Jincheng Yang, Maulik Patel, Mina Nikanjam, Edmund V Capparelli, Shirley M Tsunoda, Howard E Greenberg, Scott R Penzak, S Aubrey Stoch, Joseph S Bertino, Anne N Nafziger, Joseph D Ma
Midazolam is the preferred probe to phenotype cytochrome P450 (CYP) 3A activity. This study evaluated a single-concentration, midazolam limited sampling strategy utilizing a population pharmacokinetic (PK) approach to estimate area under the curve, and thus CYP3A activity. Midazolam concentrations from adults during CYP3A constitutive conditions were obtained from previous studies after single, oral or intravenous administration. Population PK modeling was conducted by nonlinear mixed-effects modeling. Potential covariates of clearance, volume of distribution, and bioavailability were evaluated...
April 17, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29663421/population-pharmacokinetic-analysis-of-busulfan-in-japanese-pediatric-and-adult-hct-patients
#7
Atsuko Kawazoe, Tomoo Funaki, Seongryul Kim
Busulfan is the most common chemotherapy agent used in allogeneic hematopoietic cell transplant (HCT) conditioning regimens. As narrow therapeutic index and interpatient variability exists in the effectiveness and toxicity of conditioning regimens, personalizing intravenous busulfan therapy is desirable. Population pharmacokinetic-based approaches have been applied to therapeutic drug monitoring for the purpose of personalizing therapy. A population pharmacokinetic analysis with the objective of personalizing therapy in Japanese patients was conducted by integrating pediatric patient data with adult patient data...
April 17, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29661865/modeling-and-simulation-of-pretomanid-pharmacokinetics-in-pulmonary-tuberculosis-patients
#8
Michael A Lyons
Pretomanid is a nitroimidazole antibiotic in late phase clinical testing as a component of several novel antituberculosis (anti-TB) regimens. A population pharmacokinetic model for pretomanid was constructed using a Bayesian analysis of data from two phase 2 studies, PA-824-CL-007 and PA-824-CL-010, conducted with newly diagnosed adult (median age 27 years) pulmonary TB patients in Cape Town, South Africa. Combined, these studies included 63 males and 59 females administered once daily oral pretomanid doses of 50, 100, 150, 200, 600, 1000, or 1200 mg for 14 days...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29661414/dexmedetomidine-metabolic-clearance-is-not-affected-by-fat-mass-in-obese-patients
#9
A Rolle, S Paredes, L I Cortínez, B J Anderson, N Quezada, S Solari, F Allende, J Torres, D Cabrera, V Contreras, J Carmona, C Ramírez, A M Oliveros, M Ibacache
BACKGROUND: Obesity has been associated with reduced dexmedetomidine clearance, suggesting impaired hepatic function or reduced hepatic blood flow. The aim of this study was to clarify the effect of obesity in dexmedetomidine metabolic clearance. METHODS: Forty patients, ASA I-III, 18-60 yr old, weighing 47-126 kg, scheduled for abdominal laparoscopic surgery, were enrolled. Anaesthetic agents (propofol, remifentanil, and dexmedetomidine) were dosed based on lean body weight measured by dual X-ray absorptiometry...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29661412/pharmacokinetic-pharmacodynamic-model-for-propofol-for-broad-application-in-anaesthesia-and-sedation
#10
D J Eleveld, P Colin, A R Absalom, M M R F Struys
BACKGROUND: Pharmacokinetic (PK) and pharmacodynamic (PD) models are used in target-controlled-infusion (TCI) systems to determine the optimal drug administration to achieve a desired target concentration in a central or effect-site compartment. Our aim was to develop a PK-PD model for propofol that can predict the bispectral index (BIS) for a broad population, suitable for TCI applications. METHODS: Propofol PK data were obtained from 30 previously published studies, five of which also contained BIS observations...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29661389/esketamine-counters-opioid-induced-respiratory-depression
#11
K Jonkman, E van Rijnsoever, E Olofsen, L Aarts, E Sarton, M van Velzen, M Niesters, A Dahan
BACKGROUND: Opioids can produce life-threatening respiratory depression. This study tested whether subanaesthetic doses of esketamine stimulate breathing in an established human model of opioid-induced respiratory depression. METHODS: In a study with a randomised, double blind, placebo controlled, crossover design, 12 healthy, young volunteers of either sex received a dose escalating infusion of esketamine (cumulative dose 40 mg infused in 1 h) on top of remifentanil-induced respiratory depression...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29661383/does-intranasal-dexmedetomidine-provide-adequate-plasma-concentrations-for-sedation-in-children-a-pharmacokinetic-study
#12
J W Miller, R Balyan, M Dong, M Mahmoud, J E Lam, J N Pratap, J R Paquin, B L Li, J P Spaeth, A Vinks, A W Loepke
BACKGROUND: Atomised intranasal dexmedetomidine administration is an attractive option when sedation is required for paediatric diagnostic procedures, as vascular access is not required. The risk of haemodynamic instability caused by dexmedetomidine necessitates better understanding of its pharmacokinetics in young children. To date, intranasal dexmedetomidine pharmacokinetics has only been studied in adults. METHODS: Eighteen paediatric patients received dexmedetomidine 1 or 2 μg kg-1 intranasally or 1 μg kg-1 i...
May 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29660785/integrated-population-pharmacokinetic-analysis-of-rivaroxaban-across-multiple-patient-populations
#13
Stefan Willmann, Liping Zhang, Matthias Frede, Dagmar Kubitza, Wolfgang Mueck, Stephan Schmidt, Alexander Solms, Xiaoyu Yan, Dirk Garmann
The population pharmacokinetics (PK) of rivaroxaban have been evaluated in several population-specific models. We developed an integrated population PK model using pooled data from 4,918 patients in 7 clinical trials across all approved indications. Effects of gender, age, and weight on apparent clearance (CL/F) and apparent volume of distribution (V/F), renal function, and comedication on CL/F, and relative bioavailability as a function of dose (F) were analyzed. Virtual subpopulations for exposure simulations were defined by age, creatinine clearance (CrCL) and body mass index (BMI)...
April 16, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29659758/accelerated-clearance-of-infliximab-is-associated-with-treatment-failure-in-patients-with-corticosteroid-refractory-acute-ulcerative-colitis
#14
David Kevans, Sanjay Murthy, Diane R Mould, Mark S Silverberg
Background and Aims: A significant proportion of patients with corticosteroid-refractory acute ulcerative colitis [UC] fail therapy. We aimed to assess the pharmacokinetics [PK] of infliximab [IFX] in patients with corticosteroid-refractory acute UC and determine the association between induction IFX PK and short- and long-term therapy outcome. Methods: A population PK model was developed using data from 51 patients with UC [n = 42] and Crohn's disease [n = 9]. A subset of patients [n = 36] with acute corticosteroid-refractory UC (median Mayo score 11 [range 8-12]; 33 of 36 hospitalized; median corticosteroid dose at study entry 50mg prednisolone equivalent IV/oral) commencing IFX were studied to assess further correlations between PK from the first induction dose and therapy outcomes...
April 6, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29659182/ropivacaine-wound-infiltration-for-pain-management-after-breast-cancer-mastectomy-a-population-pharmacokinetic-analysis
#15
Camille Riff, Romain Guilhaumou, Amelie Marsot, Marc Beaussier, Monique Cohen, Olivier Blin, Daniel Francon
Ropivacaine continuous wound infusions (CWIs) are extensively used as a component of multimodal analgesia. The rational application of CWI of ropivacaine requires a thorough understanding of its pharmacokinetics to investigate the risk of potential systemic toxicity. A population pharmacokinetic (popPK) study was undertaken to describe the pharmacokinetics of ropivacaine CWI during 75 hours. Women undergoing a unilateral mastectomy were scheduled to receive CWI for 40 hours for postoperative analgesia. A 10-mL ropivacaine 0...
April 16, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29655470/techniques-for-monitoring-drug-efficacy
#16
REVIEW
Marike Visser
The efficacy of drugs can vary greatly between species and individuals. Establishing efficacious drug doses for a species requires integration of population pharmacokinetic and pharmacodynamic data into a dose-response curve. Unfortunately, these data sets are rarely available for exotic species. The use of alternative monitoring techniques is required to determine drug efficacy and safety. This article discusses methods to integrate efficacy monitoring into clinical practice, including the use of diagnostic testing and therapeutic drug monitoring...
May 2018: Veterinary Clinics of North America. Exotic Animal Practice
https://www.readbyqxmd.com/read/29655372/population-pharmacokinetics-pharmacodynamics-of-micafungin-against-candida-species-in-obese-critically-ill-and-morbidly-obese-critically-ill-patients
#17
Emilio Maseda, Santiago Grau, Sonia Luque, Maria-Pilar Castillo-Mafla, Alejandro Suárez-de-la-Rica, Ana Montero-Feijoo, Patricia Salgado, Maria-Jose Gimenez, Carlos A García-Bernedo, Fernando Gilsanz, Jason A Roberts
BACKGROUND: Dosing in obese critically ill patients is challenging due to pathophysiological changes derived from obesity and/or critical illness, and it remains fully unexplored. This study estimated the micafungin probability of reaching adequate 24-h area under the curve (AUC0-24h )/minimum inhibitory concentration (MIC) values against Candida spp. for an obese/nonobese, critically ill/noncritically ill, large population. METHODS: Blood samples for pharmacokinetic analyses were collected from 10 critically ill nonobese patients, 10 noncritically ill obese patients, and 11 critically ill morbidly obese patients under empirical/directed micafungin treatment...
April 15, 2018: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/29652968/-therapeutic-monitoring-of-antimicrobial-agents-in-pediatrics-review-based-on-latin-american-experiences
#18
Brenda Zylbersztajn, Marlon Barraza, Juan P Torres, Jorge Morales
This review summarizes recommendations of therapeutic monitoring of three antimicrobials based in regional data: vancomycin, amikacin and voriconazole in pediatric population. Regional evidence agrees with international literature regarding the requirement of higher daily doses than 40 mg/kg/day of vancomycin, as well as with the possibility of use one daily doses of amikacin and to recommend higher doses of voriconazole compared to the initially recommended doses of 8 mg/kg/day. Local data on the pharmacokinetic/pharmacodynamic behavior of various antimicrobials in pediatrics are of great value for dosing adjustment in our pediatric population...
2018: Revista Chilena de Infectología: órgano Oficial de la Sociedad Chilena de Infectología
https://www.readbyqxmd.com/read/29651785/predicting-escitalopram-exposure-to-breastfeeding-infants-integrating-analytical-and-in-silico-techniques
#19
Sarah R Delaney, Paul R V Malik, Cristiana Stefan, Andrea N Edginton, David A Colantonio, Shinya Ito
BACKGROUND: Escitalopram is used for post-partum depression; however, there are limited pharmacokinetic data of escitalopram in milk and plasma of infants breastfed by women taking the drug. OBJECTIVE: The objective of this study was to apply physiologically-based pharmacokinetic (PBPK) modelling to predict infant drug exposure (plasma area under the curve from time zero to infinity [AUC∞ ]) based on drug monitoring data of escitalopram in breast milk. METHODS: Using a newly developed liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, we quantified escitalopram concentrations in milk samples of 18 breastfeeding women with escitalopram therapy at steady state, collected at three to five time points...
April 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29651213/genetic-polymorphism-of-cyp2c9-among-sistani-ethnic-group-in-gorgan
#20
Abdoljalal Marjani, Aman Mohammad Gharanjik
Cytochrome P450 2C9 (CYP2C9) is involved in metabolism of many important drugs and its genotype variations is thought to affect drug efficacy and the treatment process. The aim of this study was to assess the distribution of CYP2C9 allele and genotypic variants in Sistani ethnic group, living in Gorgan, South East of Caspian Sea and North East of Iran. This study included 140 Sistani, referred to the health center of Gorgan. CYP2C9 genotyping was carried out by polymerase chain reaction-restriction fragment length polymorphism technique...
April 2018: Indian Journal of Clinical Biochemistry: IJCB
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