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Population pharmacokinetics

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https://www.readbyqxmd.com/read/29223508/on-the-pharmacokinetics-of-two-inhaled-budesonide-formoterol-combinations-in-asthma-patients-using-modeling-approaches
#1
K Soulele, P Macheras, V Karalis
Dry powder inhalers containing the budesonide/formoterol combination have currently a well-established position among other inhaled products. Even though their efficacy mainly depends on the local concentrations of the drug they deliver within the lungs, their safety profile is directly related to their total systemic exposure. The aim of the present investigation was to explore the absorption and disposition kinetics of the budesonide/formoterol combination delivered via two different dry powder inhalers in asthma patients...
December 6, 2017: Pulmonary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29222309/using-pharmacokinetics-to-individualize-hemophilia-therapy
#2
REVIEW
Alfonso Iorio
Prevention and treatment of bleeding in hemophilia requires that plasma clotting factor activity of the replaced factor exceeds a defined target level. Most clinical decisions in hemophilia are based on implicit or explicit application of pharmacokinetic measures. The large interindividual variability in pharmacokinetics of factor concentrates suggests that relying on the average pharmacokinetic characteristics of factor concentrates would not allow optimizing the treatment of individual patients; for example, adjusting the frequency of infusions and targeting a specific clotting factor activity level on a case-by-case basis...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29218501/evaluating-safety-reporting-in-paediatric-antibiotic-trials-2000-2016-a-systematic-review-and-meta-analysis
#3
REVIEW
Paola Pansa, Yingfen Hsia, Julia Bielicki, Irja Lutsar, A Sarah Walker, Mike Sharland, Laura Folgori
BACKGROUND: There are very few options to treat multidrug-resistant bacterial infections in children. A major barrier is the duration and complexity of regulatory trials of new antibiotics. Extrapolation of safety data from adult trials could facilitate drug development for children. OBJECTIVE: We performed a systematic review on the safety of antibiotic clinical trials (CTs) in children (0-18 years) to evaluate the overall quality of safety trials conducted in children and to determine if age-specific adverse events (AEs) could be identified for specific antibiotic classes...
December 7, 2017: Drugs
https://www.readbyqxmd.com/read/29217526/first-in-human-phase-i-study-of-single-agent-vanucizumab-a-first-in-class-bi-specific-anti-ang-2-anti-vegf-antibody-in-adult-patients-with-advanced-solid-tumors
#4
Manuel Hidalgo, Maria Martinez-Garcia, Christophe Le Tourneau, Christophe Massard, Elena Garralda, Valentina Boni, Alvaro Taus, Joan Albanell, Marie-Paule Sablin, Marie Alt, Rastilav Bahleda, Andreea Varga, Christophe Boetsch, Izolda Franjkovic, Florian Heil, Angelika Lahr, Katharina Lechner, Anthony Morel, Tapan K Nayak, Simona Rossomanno, Kevin Smart, Kay-Gunnar Stubenrauch, Oliver Krieter
PURPOSE: Vanucizumab is an investigational anti-angiogenic, first-in-class, bi-specific monoclonal antibody targeting VEGF-A and angiopoietin-2 (Ang-2). This first-in-human study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of vanucizumab in adults with advanced solid tumors refractory to standard therapies. EXPERIMENTAL DESIGN: Patients received escalating bi-weekly (q2w; 3-30 mg/kg) or weekly (qw; 10-30 mg/kg) intravenous doses guided by a Bayesian logistic regression model with overdose control...
December 7, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29214439/a-pharmacometric-approach-to-substitute-for-a-conventional-dose-finding-study-in-rare-diseases-example-of-phase-iii-dose-selection-for-emicizumab-in-hemophilia-a
#5
Koichiro Yoneyama, Christophe Schmitt, Naoki Kotani, Gallia G Levy, Ryu Kasai, Satofumi Iida, Midori Shima, Takehiko Kawanishi
BACKGROUND: Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I-I/II studies, emicizumab reduced the bleeding frequency in patients with severe hemophilia A, regardless of the presence of factor VIII inhibitors, at once-weekly subcutaneous doses of 0.3, 1, and 3 mg/kg. METHODS: Using the phase I-I/II study data, population pharmacokinetic and repeated time-to-event (RTTE) modeling were performed to quantitatively characterize the relationship between the pharmacokinetics of emicizumab and reduction in bleeding frequency...
December 6, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29213040/-brivaracetam-in-the-treatment-of-patients-with-epilepsy
#6
V A Karlov, P N Vlasov, I A Zhidkova, M Ya Kissin, A V Lebedeva, L V Lipatova, V R Mkrtchyan, K Yu Mukhin, I G Rudakova
The newest antiepileptic drug (AED) brivaracetam (Briviac, UCB Pharma) (BRV) was approved in the Russian Federation in 2017 as an adjuvant therapy for the treatment of partial seizures with/without secondary generalization in adults and adolescents over 16 years old with epilepsy. This review contains the data of BRV preclinical studies, pharmacokinetic profile and the results of comparative study of BRV and LEV. The results of main studies of efficacy and tolerability with pooled analysis as well as data from meta-analysis are presented...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/29210976/therapeutic-drug-monitoring-of-asparaginase-activity-method-comparison-of-maattm-and-aha-test-used-in-the-international-aieop-bfm-all-2009-trial
#7
Claudia Lanvers-Kaminsky, Andrea Rüffer, Gudrun Würthwein, Joachim Gerss, Massimo Zucchetti, Andrea Ballerini, Andishe Attarbaschi, Petr Smisek, Christa Nath, Samiuela Lee, Sara Elitzur, Martin Zimmermann, Anja Möricke, Martin Schrappe, Carmelo Rizzari, Joachim Boos
BACKGROUND: In the international AIEOP-BFM ALL 2009 trial, asparaginase (ASE) activity was monitored after each dose of pegylated E. coli ASE (PEG-ASE). Two methods were used: the AHA test and MAAT. As the latter method overestimates PEG-ASE activity because it calibrates using E. coli ASE, method comparison was performed using samples from the AIEOP-BFM ALL 2009 trial. METHODS: PEG-ASE activities were determined by MAAT and AHA test in two sets of samples (1st set: 630 samples; 2nd set: 91 samples)...
November 23, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29209208/the-clinical-pharmacokinetics-and-pharmacodynamics-of-warfarin-when-combined-with-compound-danshen-a-case-study-for-combined-treatment-of-coronary-heart-diseases-with-atrial-fibrillation
#8
Chunxiao Lv, Changxiao Liu, Zhuhua Yao, Xiumei Gao, Lanjun Sun, Jia Liu, Haibo Song, Ziqiang Li, Xi Du, Jinxia Sun, Yanfen Li, Kui Ye, Ruihua Wang, Yuhong Huang
Warfarin is used as anticoagulant and Compound Danshen prescription (CDP) is able to promote blood circulation. The combination might produce a synergic effect for patients of coronary heart diseases (CHDs) with atrial fibrillation (AF). Whether the combination increases the bleeding risk of warfarin is unclear, so the effects of Compound Danshen dripping pill (CDDP) on the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of warfarin was investigated in patients. The dose and blood concentrations of warfarin, the four indicators of blood coagulation, prothrombin time, activated partial thromboplatin time, thrombin time, fibrinogen, and international normalized ratio value were compared when with and without CDDP treatment...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29207608/gsta1-diplotypes-affect-busulfan-clearance-and-toxicity-in-children-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-a-multicenter-study
#9
Marc Ansari, Patricia Huezo-Diaz Curtis, Chakradhara Rao S Uppugunduri, Mohammed Aziz Rezgui, Tiago Nava, Vid Mlakar, Laurence Lesne, Yves Théoret, Yves Chalandon, Lee L Dupuis, Tao Schechter, Imke H Bartelink, Jaap J Boelens, Robbert Bredius, Jean-Hugues Dalle, Saba Azarnoush, Petr Sedlacek, Victor Lewis, Martin Champagne, Christina Peters, Henrique Bittencourt, Maja Krajinovic
Busulfan (BU) dose adjustment following therapeutic drug monitoring contributes to better outcome of hematopoietic stem cell transplantation (HSCT). Further improvement could be achieved through genotype-guided BU dose adjustments. To investigate this aspect, polymorphism within glutathione S transferase genes were assessed. Particularly, promoter haplotypes of the glutathione S transferase A1 (GSTA1) were evaluated in vitro, with reporter gene assays and clinically, in a pediatric multi-center study (N =138) through association with BU pharmacokinetics (PK) and clinical outcomes...
October 31, 2017: Oncotarget
https://www.readbyqxmd.com/read/29206086/early-use-of-tacrolimus-extended-release-in-a-pediatric-kidney-transplant-recipient
#10
Kristen R Szempruch, Katherine D Westreich, Alexander H Toledo
Tacrolimus extended-release pharmacokinetics and its once-daily formulation provide beneficial properties, and its use has been evaluated in the adult kidney transplant population. Here, we report a case of successful conversion from tacrolimus immediate-release capsules to tacrolimus extended-release tablets in a pediatric kidney transplant recipient.
December 5, 2017: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/29204823/balancing-antibacterial-efficacy-and-reduction-in-renal-function-to-optimise-initial-gentamicin-dosing-in-paediatric-oncology-patients
#11
Carolina Consuelo Llanos-Paez, Christine Staatz, Stefanie Hennig
This study aimed to determine the optimal starting dose of gentamicin in paediatric oncology patients. A population pharmacokinetic model describing drug exposure, a semi-mechanistic model describing bacterial killing and an Emax model describing renal cortex accumulation were linked in a utility function using NONMEM®. The optimal gentamicin starting dose was estimated in patients aged from 0.1 to 18.2 years, by balancing the probability of efficacy on day 1 against relative renal function reduction on day 7 with continued dosing...
December 4, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29204688/pharmacokinetics-of-recombinant-asparaginase-in-children-with-acute-lymphoblastic-leukemia
#12
Swantje Völler, Uwe Pichlmeier, Anke Zens, Georg Hempel
PURPOSE: The objective of this study was to assess the pharmacokinetics of recombinant asparaginase (rASNase, Spectrila®) in children with acute lymphoblastic leukemia using a population pharmacokinetic approach in order to explore potential dosing recommendations. METHODS: Data on serum asparaginase activities of 124 children from three clinical studies were included in the analysis, covering an age range from 3 days to 17 years. Most patients received 5000 U/m2 rASNase intravenously every 3 days...
December 5, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29203151/population-pharmacokinetic-evaluation-of-adv6209-an-innovative-oral-solution-of-midazolam-containing-cyclodextrin
#13
Frédéric Marçon, Catherine Guittet, Maria A Manso, Ingrid Burton, Luc-André Granier, Philippe Jacqmin, Hervé Dupont
INTRODUCTION: In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative 2mg/mL oral solution of midazolam containing cyclodextrin, has been developed for moderate sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported. METHODS: Plasma concentration data were collected from 37 paediatric patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-period crossover bioavailability study, respectively...
December 1, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29202789/paracetamol-clinical-dosing-routine-leads-to-paracetamol-underexposure-in-an-adult-severely-ill-sub-saharan-african-hospital-population-a-drug-concentration-measurement-study
#14
Jeannet C Bos, Mabor C Mistício, Ginto Nunguiane, Ron A A Mathôt, Reinier M van Hest, Jan M Prins
BACKGROUND: Hospitals in sub-Saharan Africa (SSA) continue to receive high numbers of severely ill (HIV-infected) patients with physical pain that may suffer from hepatic and renal dysfunction. Paracetamol is widely used for pain relief in this setting but it is unknown whether therapeutic drug concentrations are attained. The aim of this study was to assess the occurrence of therapeutic, sub-therapeutic and toxic paracetamol concentrations in SSA adult hospital population. METHODS: In a cross-sectional study, plasma paracetamol concentrations were measured in patients with an oral prescription in a referral hospital in Mozambique...
December 4, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/29202215/pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-dabigatran-etexilate-oral-liquid-formulation-in-infants-with-venous-thromboembolism
#15
Jacqueline M L Halton, Anne-Caroline Picard, Ruth Harper, Fenglei Huang, Martina Brueckmann, Savion Gropper, Hugo Maas, Igor Tartakovsky, Ildar Nurmeev, Lesley G Mitchell, Leonardo R Brandão, Elizabeth Chalmers, Manuela Albisetti
Venous thromboembolism (VTE) is more frequent in infants than in older children. Treatment guidelines in children are adapted from adult VTE data, but do not currently include direct oral anticoagulant use. Dabigatran etexilate (DE) use in the paediatric population with VTE therefore requires verification. We investigated the pharmacokinetic/pharmacodynamic (PK/PD) relationship, safety and tolerability of DE oral liquid formulation (OLF) in infants with VTE (aged < 12 months) who had completed standard anticoagulant treatment in an open-label, phase IIa study...
November 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/29200097/external-evaluation-of-population-pharmacokinetic-models-of-infliximab-in-inflammatory-bowel-disease-patients
#16
Eugènia Santacana, Lorena Rodríguez-Alonso, Ariadna Padullés, Jordi Guardiola, Francisco Rodríguez-Moranta, Katja Serra, Jordi Bas, Francisco Morandeira, Helena Colom, Núria Padullés
BACKGROUND: Infliximab (IFX) trough levels vary markedly between patients with inflammatory bowel disease (IBD), which is important for clinical response. The aim of this study was to evaluate the performance of previously developed population pharmacokinetic models in IBD patients for dose individualization for Crohn's disease and ulcerative colitis in our clinical setting. METHODS: The authors collected 370 trough levels prospectively from 100 adult IBD patients who were undergoing IFX treatment between July 2013 and August 2016...
December 1, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29198064/claiming-desmopressin-therapeutic-equivalence-in-children-requires-pediatric-data-a-population-pkpd-analysis
#17
Robin Michelet, Lien Dossche, Charlotte Van Herzeele, Jan Van Bocxlaer, An Vermeulen, Johan Vande Walle
PURPOSE: For a new formulation of a drug, only pharmacokinetic bioequivalence with the original formulation has to be demonstrated in healthy, young adults. However, "children are not small adults," and to guarantee a safe and effective treatment, age-adapted drug development is required. Desmopressin, a vasopressin analogue prescribed for nocturnal enuresis in children, was studied as an example formulation first developed in adults and then extrapolated to a pediatric indication. METHODS: Population pharmacokinetic and pharmacodynamic modeling was used to analyze previously published desmopressin data of 18 children suffering from nocturnal enuresis...
December 3, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29197630/population-pharmacokinetics-of-articaine-with-1-200-000-epinephrine-during-third-molar-surgery-and-simulation-of-high-dose-regimens
#18
Yoann Cazaubon, Cédric Mauprivez, Catherine Feliu, Laurent Binet, Olivier Oget, Claire Gozalo, Zoubir Djerada
BACKGROUND AND OBJECTIVES: Articaine is more and more used in third molar surgery under local anesthesia (LA). The objectives of this analysis were to characterize the pharmacokinetics of articaine for this type of surgery and to simulate dosing regimens. METHODS: Non-linear mixed-effects modeling conducted in Monolix 4.4.0 was used to describe articaine plasma concentration-time data from 20 patients. Monte Carlo simulations were then performed to evaluate the probability of cardiotoxic target attainment (PCTA) of various dosage regimens...
November 29, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29197167/to-take-or-not-to-take-with-meals-unraveling-issues-related-to-food-effects-labeling-for-oral-antineoplastic-drugs
#19
Jiexin Deng, Satjit S Brar, Lawrence J Lesko
There has been controversy regarding whether bioavailability of certain oral oncology drugs should be maximized by taking these medications with food, irrespective of label instructions in the dosing and administration section. To provide insight into this controversy, we conducted an in-depth analysis for oral antineoplastic drugs approved by the Food and Drug Administration in 2000-2016 and identified important issues influencing food labeling decisions. Furthermore, a case study involving sonidegib, a drug approved for locally advanced basal cell carcinoma with a significant food effect on exposure, was used to demonstrate the consequences of failure to adhere to food label recommendations using drug-specific population pharmacokinetic and exposure-toxicity models...
December 2, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29195829/importance-of-vancomycin-loading-doses-in-intermittent-infusion-regimens
#20
Martin Šíma, Jan Hartinger, Tereza Cikánková, Ondřej Slanař
PURPOSE: Delayed achievement of target vancomycin serum concentrations may adversely affect clinical outcomes. The objective of this retrospective study was to explore the real frequency of loading dose use and to evaluate the impact of loading dose for the achievement of vancomycin PK/PD target in adult patients treated with intermittent vancomycin. As a secondary aim we determined optimal vancomycin loading dose based on individual pharmacokinetic calculations. METHODS: Vancomycin pharmacokinetic models were computed using two-compartmental analysis...
November 28, 2017: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
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