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European Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28233047/no-clinically-meaningful-pharmacokinetic-interaction-between-the-hepatitis-c-virus-inhibitors-elbasvir-and-grazoprevir-and-the-oral-contraceptives-ethinyl-estradiol-and-levonorgestrel
#1
William L Marshall, Hwa-Ping Feng, Luzelena Caro, Jennifer Talaty, Zifang Guo, Xiaobi Huang, Deborah Panebianco, Joanne Ma, Eric Mangin, Terry E O'Reilly, Joan R Butterton, Wendy W Yeh
PURPOSE: Oral contraceptive pills (OCPs) are an important element of hepatitis C virus (HCV) treatment in women of childbearing potential. These studies evaluated the safety and pharmacokinetic interactions between elbasvir (EBR) and grazoprevir (GZR) and ethinyl estradiol/levonorgestrel (EE/LNG). METHODS: Both studies were open-label, single-site, two-period, fixed-sequence, one-way interaction studies. In period 1, subjects received one tablet of EE/LNG (0.03 mg/0...
February 24, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28204907/erratum-to-safety-of-zidovudine-lamivudine-scored-tablets-in-children-with-hiv-infection-in-europe-and-thailand
#2
(no author information available yet)
No abstract text is available yet for this article.
February 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28197684/definition-of-variables-required-for-comprehensive-description-of-drug-dosage-and-clinical-pharmacokinetics
#3
Anna V Medem, Hanna M Seidling, Hans-Georg Eichler, Jens Kaltschmidt, Michael Metzner, Carina M Hubert, David Czock, Walter E Haefeli
PURPOSE: Electronic clinical decision support systems (CDSS) require drug information that can be processed by computers. The goal of this project was to determine and evaluate a compilation of variables that comprehensively capture the information contained in the summary of product characteristic (SmPC) and unequivocally describe the drug, its dosage options, and clinical pharmacokinetics. METHODS: An expert panel defined and structured a set of variables and drafted a guideline to extract and enter information on dosage and clinical pharmacokinetics from textual SmPCs as published by the European Medicines Agency (EMA)...
February 14, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28188332/adjudication-of-osteonecrosis-of-the-jaw-in-phase-iii-randomized-controlled-trials-of-denosumab-a-systematic-review
#4
REVIEW
Paul de Boissieu, L Kanagaratnam, R Mahmoudi, A Morel, M Dramé, T Trenque
PURPOSE: Denosumab (an anti RANKL antibody) is known to be associated with an increased risk for osteonecrosis of the jaw (ONJ). Due to the variety of clinical presentation, many ONJ definitions are used. Evaluation of ONJ's frequency during phase III randomized controlled trials (RCTs) is crucial to assess benefit-risk ratio. We verified that phase III RCTs involving denosumab reported the definition of ONJ used. METHODS: We systematically searched in Central, Medline, Cochrane, and Scopus, until 31 August 2015...
February 10, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28180945/effect-of-magnesium-supplementation-on-lipid-profile-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#5
REVIEW
Luis E Simental-Mendía, Mario Simental-Mendía, Amirhossein Sahebkar, Martha Rodríguez-Morán, Fernando Guerrero-Romero
PURPOSE: We performed a meta-analysis of randomized controlled trials (RCTs) in order to evaluate the effect of oral magnesium supplementation on lipid profile of both diabetic and non-diabetic individuals. METHODS: PubMed-Medline, SCOPUS, Web of Science, and Google Scholar databases were searched (from inception to February 23, 2016) to identify RCTs evaluating the effect of magnesium on lipid concentrations. A random-effects model and generic inverse variance method were used for quantitative data synthesis...
February 9, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28168312/valproic-acid-induced-hyperammonemic-encephalopathy-in-a-full-term-neonate-a-brief-review-and-case-report
#6
LETTER
Pavla Pokorná, Karolina Hronová, Martin Šíma, Ondřej Slanař, Petr Klement, John N van den Anker, Dick Tibboel
No abstract text is available yet for this article.
February 6, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28161750/quality-assessment-of-structure-and-language-elements-of-written-responses-given-by-seven-scandinavian-drug-information-centres
#7
Linda Amundstuen Reppe, Olav Spigset, Jens Peter Kampmann, Per Damkier, Hanne Rolighed Christensen, Ylva Böttiger, Jan Schjøtt
PURPOSE: The aim of this study was to identify structure and language elements affecting the quality of responses from Scandinavian drug information centres (DICs). METHODS: Six different fictitious drug-related queries were sent to each of seven Scandinavian DICs. The centres were blinded for which queries were part of the study. The responses were assessed qualitatively by six clinical pharmacologists (internal experts) and six general practitioners (GPs, external experts)...
February 5, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28160012/first-in-human-studies-of-seletalisib-an-orally-bioavailable-small-molecule-pi3k%C3%AE-inhibitor-for-the-treatment-of-immune-and-inflammatory-diseases
#8
Eric Helmer, Mark Watling, Emma Jones, Dominique Tytgat, Mark Jones, Rodger Allen, Andrew Payne, Annelize Koch, Eugene Healy
PURPOSE: PI3Ks are potential therapeutic targets in immune-inflammatory diseases. These studies aimed to investigate the safety, tolerability and PK profile of seletalisib, a selective inhibitor of PI3Kδ in humans. METHODS: These phase I, randomised, double-blind, placebo-controlled, single-centre studies (NCT02303509, NCT02207595) evaluated single and multiple oral doses of seletalisib (5-90 mg QD and 30 mg BID) in healthy adults and subjects with mild-to-moderate psoriasis (Study-1)...
February 4, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28144724/pharmacokinetics-of-a-new-nasal-formulation-of-naloxone
#9
Ida Tylleskar, Arne Kristian Skulberg, Turid Nilsen, Sissel Skarra, Phatsawee Jansook, Ola Dale
PURPOSE: Nasal naloxone is wanted for bystander administration in opioid overdose and as a needle-free alternative for emergency medical personnel. Epidemiologic studies have indicated a therapeutic effect of bystander administration of low-concentration/high-volume formulations. The objective for this study was to describe the nasal pharmacokinetics of a new high-concentration/low-volume nasal formulation of naloxone. METHODS: This was an open, randomized triple crossover trial in healthy, human volunteers (n = 12) where two doses of nasal naloxone (0...
January 31, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28138748/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-dexlansoprazole-injection-in-healthy-chinese-subjects
#10
Yue-Qi Li, Zheng-Yu Yan, Hong-Wen Zhang, Lu-Ning Sun, Hui-Wen Jiao, Mei-Feng Wang, Li-Yuan Yu, Lei Yu, Zi-Qing-Yun Yuan, Ling Meng, Yong-Qing Wang
PURPOSE: This study was conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of dexlansoprazole injection in healthy subjects. METHODS: Dexlansoprazole (20-90 mg) or lansoprazole (30 mg) was administrated intravenously to healthy male and female volunteers. All the subjects were sampled for pharmacokinetic (PK) analysis and 64 of them were monitored for 24-h intragastric pH prior to and after administration in the pharmacodynamic (PD) study...
January 31, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28132082/high-tacrolimus-blood-concentrations-early-after-lung-transplantation-and-the-risk-of-kidney-injury
#11
M A Sikma, C C Hunault, E A van de Graaf, M C Verhaar, J Kesecioglu, D W de Lange, J Meulenbelt
PURPOSE: Lung transplant recipients often develop acute kidney injury (AKI) evolving into chronic kidney disease (CKD). The immunosuppressant tacrolimus might be associated with the emergence of AKI. We analyzed the development and recovery of kidney injury after lung transplantation and related AKI to whole-blood tacrolimus trough concentrations and other factors causing kidney injury. METHODS: We retrospectively studied kidney injury in 186 lung-transplantation patients at the UMC Utrecht between 2001 and 2011...
January 28, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28132081/intravenous-methylprednisolone-induced-acute-pancreatitis
#12
LETTER
N Yahiaoui, M Roche, N Aissaoui-Hoffmann, B A Keita, M Mallaret
No abstract text is available yet for this article.
January 28, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28108782/contextualizing-patient-care-opportunities-for-pharmacotherapy-education
#13
LETTER
David J Brinkman, Jelle Tichelaar, Michiel A van Agtmael
No abstract text is available yet for this article.
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28108781/potentially-inappropriate-medications-predictor-for-mortality-in-a-cohort-of-community-dwelling-older-adults
#14
Mariana Martins Gonzaga do Nascimento, Juliana Vaz de Melo Mambrini, Maria Fernanda Lima-Costa, Josélia Oliveira Araújo Firmo, Sérgio William Viana Peixoto, Antônio Ignácio de Loyola Filho
PURPOSE: The objective of this study was to investigate whether the potentially inappropriate medication (PIM) use is a predictor for mortality in a community-based population of older adults. METHODS: A cohort study was performed between January 1, 1997, and December 31, 2011, based on data from a representative sample of the population aged 60 years or older living in Bambuí, Brazil. Univariate and multivariate analyses of the association between the variable of interest (use of PIM or pharmacological groups of PIM) and mortality were based on the extended Cox model for proportional hazards...
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28105514/acknowledgment-to-referees
#15
(no author information available yet)
No abstract text is available yet for this article.
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28105513/pharmacokinetics-of-ginkgolides-a-b-and-k-after-single-and-multiple-intravenous-infusions-and-their-interactions-with-midazolam-in-healthy-chinese-male-subjects
#16
Feng Shao, Hongwen Zhang, Lijun Xie, Juan Chen, Sufeng Zhou, Jinsong Zhang, Jinru Lv, Weiwen Hao, Yunsu Ma, Yun Liu, Ning Ou, Wei Xiao
PURPOSE: Ginkgo terpene lactones meglumine injection (GMI) is a novel preparation of traditional Chinese medicine that contains ginkgolides A, B and K (GA, GB, GK, respectively) as its primary components. In this study we evaluated the safety, tolerability and pharmacokinetics of these three ginkgolides after single and multiple intravenous infusions of GMI. We also investigated the effect of GMI on cytochrome P450 3A4 (CYP3A4) in healthy Chinese volunteers. METHODS: In this open-label, placebo-controlled study 15 subjects were randomly assigned to receive GMI or matched placebo (4:1 ratio)...
January 20, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28101657/levodopa-carbidopa-microtablets-in-parkinson-s-disease-a-study-of-pharmacokinetics-and-blinded-motor-assessment
#17
Marina Senek, Sten-Magnus Aquilonius, Håkan Askmark, Filip Bergquist, Radu Constantinescu, Anders Ericsson, Sara Lycke, Alexander Medvedev, Mevludin Memedi, Fredrik Ohlsson, Jack Spira, Jerker Westin, Dag Nyholm
BACKGROUND: Motor function assessments with rating scales in relation to the pharmacokinetics of levodopa may increase the understanding of how to individualize and fine-tune treatments. OBJECTIVES: This study aimed to investigate the pharmacokinetic profiles of levodopa-carbidopa and the motor function following a single-dose microtablet administration in Parkinson's disease. METHODS: This was a single-center, open-label, single-dose study in 19 patients experiencing motor fluctuations...
January 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28101656/off-label-use-of-antimicrobials-in-neonates-in-a-tertiary-children-s-hospital
#18
Niina Laine, Ann Marie Kaukonen, Kalle Hoppu, Marja Airaksinen, Harri Saxen
PURPOSE: Off-label (OL) use of drugs for hospitalized children is very common. OL use occurs especially in the youngest patients, neonates. This study focused on the OL use of antimicrobials in neonates. To our knowledge, only few studies have focused on the prevalence of OL use of antimicrobials in neonates. METHODS: We investigated the OL use of antimicrobials in neonates in a tertiary children's hospital. First, we investigated what were the most consumed OL antimicrobials in defined daily doses according to hospital's registry data from neonatal intensive care unit (NICU) during 2009-2014...
January 18, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28093640/polypharmacy-and-potentially-inappropriate-medications-a-cross-sectional-analysis-among-451-nursing-homes-in-france
#19
Marie Herr, Helene Grondin, Stéphane Sanchez, Didier Armaingaud, Caroline Blochet, Antoine Vial, Philippe Denormandie, Joël Ankri
PURPOSE: The quality of drug therapy is an important issue for nursing homes. This study aimed to assess the prevalence of polypharmacy and potentially inappropriate medications (PIMs) in a large sample of nursing home residents by using the data recorded during the preparation of pill dispensers. METHODS: This is a cross-sectional study that included 451 nursing homes across France. Information about the medications received by the 30,702 residents (73.8% women) living in these nursing homes was extracted from the system that assists in the preparation of pill dispensers in pharmacies...
January 16, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28091704/medical-students-medication-communication-skills-regarding-drug-prescription-a-qualitative-analysis-of-simulated-physician-patient-consultations
#20
Katarina Hauser, Jan Matthes
PURPOSE: Poor medication communication of physicians to patients is detrimental, e.g. for medication adherence. Reasons for physicians' deficits in medication communication may be unfavourable conditions in daily practice or already insufficient training during their (undergraduate) medical studies. We explored medical students' communication on new medications in simulated physician-patient conversations to identify actual deficits indicating apparent educational needs. METHODS: Fifth year medical students attending a mandatory course at the University of Cologne had simulated physician-patient consultations aiming at drug prescription...
January 14, 2017: European Journal of Clinical Pharmacology
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