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British Journal of Clinical Pharmacology

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https://read.qxmd.com/read/31419329/efficacy-of-thn102-a-combination-of-modafinil-and-flecainide-on-vigilance-and-cognition-during-40-hour-total-sleep-deprivation-in-healthy-subjects-glial-connexins-as-a-therapeutic-target
#1
F Sauvet, M Erblang, D Gomez-Merino, A Rabat, M Guillard, H Dubourdieu, H Lefloch, C Drogou, P Van Beers, C Bougard, C Bourrrilhon, P Arnal, W Rein, F Mouthon, F Brunner-Ferber, D Leger, Y Dauvilliers, M Chennaoui, M Charvériat
AIMS: THN102 is a novel combination of modafinil and low-dose flecainide, targeting glial connexin activity to modulate modafinil effects. We investigated THN102 efficacy compared to modafinil and to placebo on vigilance and cognitive function during 40-h total sleep deprivation (TSD). METHODS: 20 healthy men participated in a double-blind, randomized, incomplete-block 3-period cross-over trial with 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD100), THN102 100/1, 100/3, 100/9 (modafinil 100mg and flecainide 1, 3 or 9 mg)...
August 16, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31418914/methylphenidate-and-stuttering
#2
Thierry Trenque, Gwladys Claustre, Emmanuelle Herlem, Zoubir Djerada, Agathe Trenque, Aurore Morel, Brahim Azzouz
Methylphenidate (MPH) is a piperidine similar to amphetamines, and is indicated for Attention Deficit Hyperactivity Disorder. Studies concerning stuttering occurring with methylphenidate are contradictory. We investigated the association between methylphenidate and stuttering. We analyzed reports in the World Health Organization global individual case safety reports database, Vigibase, up to 31 December 2018, with the MedDRA Preferred Term "dysphemia" and the Lower Level Terms "stutter" and "stuttering"...
August 16, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31418911/population-pharmacokinetic-modeling-and-simulation-of-fremanezumab-in-healthy-subjects-and-patients-with-migraine
#3
J B Fiedler-Kelly, O Cohen-Barak, D N Morris, E Ludwig, M Rasamoelisolo, H Shen, M Levi
AIMS: Fremanezumab is a fully humanized IgG2 Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) developed and approved for the preventive treatment of migraine in adults. The population pharmacokinetics (PK) of fremanezumab were characterized in healthy subjects and patients with chronic migraine (CM) and episodic migraine (EM), including the effects of intrinsic and extrinsic factors on PK variability. METHODS: Nonlinear mixed effects modelling was performed using NONMEM with data from seven phase 1-3 clinical trials evaluating selected intravenous (iv) and subcutaneous (sc) dose regimens...
August 16, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31418902/the-impact-of-a-medication-reconciliation-program-at-geriatric-hospital-admission-a-pre-post-intervention-study
#4
Pi-Lien Hung, Jung-Yi Chen, Miao-Ting Chen, Pao-Lin Li, Wei-Chi Li, Zi-Cheng Wang, Tzu-Ting Huang, Yen-Tzu Liang, Pei-Chin Lin
AIMS: The aim of this study was to improve medication reconciliation and reduce the occurrence of duplicate prescriptions by pharmacists and physicians within 72 hours of hospital admission using an intelligent prescription system combined with the National PharmaCloud system to integrate the database with the medical institution Computerized Physician Order Entry (CPOE) system. METHODS: This two-year intervention study was implemented in the geriatric ward of a hospital in Taiwan...
August 16, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31410871/reply-to-innovation-and-off-label-use-the-french-case-and-more-by-braillon-and-lexchin
#5
LETTER
Jan Borysowski, Hans-Jörg Ehni, Andrzej Górski
No abstract text is available yet for this article.
August 13, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31400011/spotlight-commentary-model-informed-precision-dosing-must-demonstrate-improved-patient-outcomes
#6
EDITORIAL
Daniel F B Wright, Jennifer H Martin, Serge Cremers
No abstract text is available yet for this article.
August 9, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31396983/polyethylene-glycol-loxenatide-pex168-in-subjects-with-renal-impairment-a-pharmacokinetic-study
#7
Jianwen Wang, Jie Huang, Wei Li, Shiqi Tang, Jian Sun, Xianming Zhang, Jun Liu, Bin Yi, Jishi Liu, Xingfei Zhang, Qian Yang, Xiaoyan Yang, Shuang Yang, Guoping Yang, Hao Zhang
AIMS: Type 2 diabetes mellitus (T2DM) is commonly complicated by renal impairment. Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM. PEX168 pharmacokinetics (PK) was studied to identify requirements for dose-modification in T2DM complicated by renal impairment. METHODS: This was a single-center, open-labeled, parallel-group, single-dose, phase I clinical trial of patients with mild and moderate renal impairment, and with or without T2DM...
August 8, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31393022/tyrosine-kinase-inhibitors-tkis-used-in-the-management-of-chronic-myeloid-leukemia-are-associated-with-hematologic-toxicities-which-tki-is-the-safest
#8
LETTER
Ahmet Emre Eşkazan
No abstract text is available yet for this article.
August 8, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31392771/the-ice-cream-challenge-a-favourable-extemporaneous-kayexalate-formulation-improves-compliance-in-paediatric-patients
#9
LETTER
Keren Shahar-Nissan, Orit Peled, Irit Krause
No abstract text is available yet for this article.
August 7, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31389059/why-is-the-therapeutic-effect-of-acute-antimigraine-drugs-delayed-a-review-of-controlled-trials-and-hypotheses-about-the-delay-of-effect
#10
REVIEW
Peer Tfelt-Hansen, Karl Messlinger
In randomised, controlled trials (RCTs) of oral drug treatment of migraine attacks, efficacy is evaluated after 2 hours. The effect of oral naratriptan 2.5 mg with a maximum blood concentration (Tmax ) at 2 hours increases from 2 to 4 hours in RCTs. To check whether such a delayed effect is also present for other oral antimigraine drugs, we hand-searched the literature for publications on RCTs reporting efficacy. Two triptans, three non-steroidal anti-inflammatory drugs (NSAIDs), a triptan combined with an NSAID, and a calcitonin gene-related peptide receptor antagonist were evaluated for their therapeutic gain with determination of time to maximum effect (Emax )...
August 6, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31389036/risk-assessment-of-using-off-label-morphine-sulfate-in-a-population-based-retrospective-cohort-of-opioid-dependent-patients
#11
Célian Bertin, Jessica Delorme, Marie Riquelme, Hélène Peyrière, Georges Brousse, Alain Eschalier, Denis Ardid, Chouki Chenaf, Nicolas Authier
AIMS: Several addictovigilance studies have described the off-label use of morphine sulfate (MS) for non-chronic pain in opioid use disorder (OUD) patients as an alternative to conventional opioid substitution treatments (OSTs). This study primarily sought to compare the incidence of unintentional opioid-related overdose in the year following the prescription initiation in off-label MS users, compared to OST-maintained patients. METHODS: Sequential cohorts of OUD patients who were regularly dispensed MS, buprenorphine, or methadone, between April 1, 2012 and December, 31, 2014, were retrospectively identified using the French nationwide healthcare data system...
August 6, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31385322/evaluation-of-online-clinical-pharmacology-curriculum-resources-for-medical-students
#12
Xi Yue Zhang, Anne M Holbrook, Laura Nguyen, Justin Lee, Saeed AlQahtani, Michael Cristian Garcia, Dan Perri, Mitchell Levine, Rakesh V Patel, Simon Maxwell
INTRODUCTION: AIMS: To identify and evaluate Clinical Pharmacology (CP) online curricular (e-Learning) resources that are internationally available for medical students. METHODS: Literature searches of Medline, EMBASE, and ERIC databases and an online survey of faculty members of international English language medical schools, were used to identify CP e-Learning resources. Resources which were accessible online in English, and aimed to improve the quality of prescribing specific medications were then evaluated using a summary percentage score for comprehensiveness, usability and quality, and for content suitability...
August 5, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31378978/social-media-monitoring-on-the-perceived-safety-of-medication-use-during-pregnancy-a-case-study-from-the-netherlands
#13
Marleen M H J van Gelder, Annemarije Rog, Sebastian J H Bredie, Wietske Kievit, Hedvig Nordeng, Tom H van de Belt
AIMS: An increasing number of women trust the Internet for information about medication safety during pregnancy. This study aimed to evaluate the availability and accuracy of social media content on the perceived safety of medication use in pregnancy. METHODS: We performed a systematic search of posts related to medication safety during pregnancy in the Dutch language published on social media, blogs, and forums between May 2011 and April 2016 using Coosto, a tool for social media monitoring...
August 4, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31378961/biosimilars-of-low-molecular-weight-heparins-relevant-background-information-for-your-drug-formulary
#14
REVIEW
Jacobus R B J Brouwers, Jeanine E Roeters van Lennep, Maarten J Beinema
Biosimilars of Low Molecular Weight Heparins are more alike with the originator than the different branded LMWHs. The latter differ largely in Molecular Weight, anti FXa/anti FIIa ratio and anti-thrombin binding. The FDA and EMA guidelines are sufficient for the clinical use of high quality LMWHs. But the FDA guideline lacks the results of a fase I clinical trial in the approval process. Most information about biosimilar is available for enoxaparin given the fact that many biosimilars of enoxaparin have received market access...
August 4, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31378957/vancomycin-is-commonly-under-dosed-in-critically-ill-children-and-neonates
#15
Natasha Sosnin, Nigel Curtis, Noel Cranswick, Roberto Chiletti, Amanda Gwee
OBJECTIVES: Vancomycin is frequently used in critically ill children in whom the drug pharmacokinetics are significantly altered as a result of changes in renal clearance and volume of distribution. Therapeutic drug monitoring (TDM) is recommended to achieve vancomycin trough concentrations between 10 and 20 mg/L. In this study we reviewed vancomycin dosing, TDM and treatment outcomes in paediatric and neonatal intensive care unit (PICU and NICU) patients. METHODS: We reviewed the medical records of all patients receiving intravenous vancomycin in a tertiary PICU and NICU over a 10-month period...
August 4, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31378954/assessment-of-extrip-criteria-for-the-decision-of-extracorporeal-toxin-removal-in-lithium-poisoning
#16
Dominique Vodovar, Sébastien Beaune, Jérôme Langrand, Eric Vicaut, Laurence Labat, Bruno Mégarbane
AIMS: To assess recommendations provided by the EXTRIP workgroup on extracorporeal toxin removal (ECTR) in lithium poisoning. METHODS: Retrospective assessment in a 128 lithium-poisoned patient cohort previously used to identify ECTR initiation criteria that could improve outcome (Paris criteria). ECTR requirement using EXTRIP criteria was compared to the actual practice or if Paris criteria were used. The potential impact on outcome if these different criteria were used was investigated...
August 4, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31378952/clinical-and-pharmacokinetics-equivalence-of-multiple-doses-of-levodopa-benserazide-generic-formulation-versus-the-originator-madopar%C3%A2
#17
M Torti, J Alessandroni, D Bravi, M Casali, P Grassini, C Fossati, C Ialongo, M Onofrj, F G Radicati, L Vacca, S Bonassi, F Stocchi
BACKGROUND: While a number of generic preparations of Levodopa/carbidopa and Levodopa/benserazide are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with Levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug. METHODS: An experimental, two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study was designed to evaluate both the PK equivalence and clinical equivalence of multiple doses of the "generic" preparation of Levodopa benserazide (LDB), Teva Italia, compared to the "originator" (Madopar®)...
August 4, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31376180/celecoxib-induced-bullous-fixed-drug-eruption-an-unusual-presentation
#18
LETTER
Helmi Ammar, Nadia Ben Fredj, Najeh Ben Fadhel, Zohra Chadli, Haifa Ben Romdhane, Naceur A Boughattas, Amel Chaabane, Karim Aouam
No abstract text is available yet for this article.
August 2, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31373717/vaccine-safety-an-evolving-evidence-based-science
#19
LETTER
Bruce M McClenathan, Kathryn M Edwards
No abstract text is available yet for this article.
August 2, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31368147/measuring-the-impact-of-pharmacovigilance-activities-challenging-but-important
#20
EDITORIAL
Florence van Hunsel, Helga Gardarsdottir, Anthonius de Boer, Agnes Kant
No abstract text is available yet for this article.
July 31, 2019: British Journal of Clinical Pharmacology
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