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British Journal of Clinical Pharmacology

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https://read.qxmd.com/read/31112623/effect-of-hepatic-impairment-on-the-pharmacokinetics-of-vilaprisan-an-open-label-single-dose-parallel-group-study
#1
N Chattopadhyay, K Riecke, S Ligges, T Zimmermann, A Halabi, M-H Schultze-Mosgau
AIMS: The study objective was to evaluate the pharmacokinetics of the selective progesterone receptor modulator vilaprisan in participants with hepatic impairment. Additionally, the safety and tolerability of vilaprisan were investigated. METHODS: In this phase 1, open-label, non-randomised, parallel-group, pharmacokinetic study, men and women with mild or moderate hepatic impairment (Child-Pugh grade A or B) and control participants with normal hepatic function matched by age, weight and sex received a single oral 2 mg dose of vilaprisan...
May 21, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31112622/nonlinear-pharmacokinetics-of-rituximab-in-non-hodgkin-lymphomas-a-pilot-study
#2
David Ternant, Hélène Monjanel, Yann Venel, Caroline Prunier-Aesch, Flavie Arbion, Philippe Colombat, Gilles Paintaud, Emmanuel Gyan
AIMS: Rituximab is an anti-CD20 monoclonal antibody approved in non-Hodgkin lymphoma (NHL). This study aimed at assessing the relationship between antigen mass and nonlinear pharmacokinetics of rituximab in NHL patients. METHODS: In a retrospective cohort of 25 NHL patients treated with rituximab, antigen mass was assessed at baseline by measuring metabolic tumor volume (MTV) by positron emission tomography. Rituximab pharmacokinetics was described using a semi-mechanistic two-compartment model including a latent target antigen...
May 21, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31112621/pharmacokinetics-and-safety-of-tobramycin-nebulization-with-the-i-neb%C3%A2-and-pari-lc-plus%C3%A2-in-children-with-cystic-fibrosis-a-randomized-crossover-study
#3
A J van Velzen, J W F Uges, H G M Heijerman, H G M Arets, M Nuijsink, E C van der Wiel-Kooij, E M van Maarseveen, G A van Zanten, B Pullens, D J Touw, H M Janssens
AIMS: We aimed to compare the pharmacokinetics (PK) and safety profile of tobramycin inhalation solution (TIS) using the I-neb device to the standard PARI-LC® Plus nebulizer in children with cystic fibrosis (CF). METHODS: A randomized, open-label, crossover study was performed. In two separate study visits blood samples from 22 children were collected following TIS nebulization with the I-neb (75 mg) and PARI-LC Plus (300 mg). Study visits were separated by one month, in which one of the study nebulizers was used twice daily...
May 21, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31112617/optimizing-the-dose-in-patients-treated-with-imatinib-as-first-line-treatment-for-gastrointestinal-stromal-tumors-a-cost-effectiveness-study
#4
Ingrid M E Desar, Sander Zuidema, Nielka P van Erp, Wietske Kievit
BACKGROUND: Patients with metastatic gastro intestinal stromal tumors (GIST) are treated in first line with the oral tyrosine kinase inhibitor, imatinib, until progressive disease. With this fixed dosing regimen, only approximately 40% of patients reach adequate plasma levels within the therapeutic index. Therapeutic drug monitoring (TDM) is an solution to reach plasma levels within the therapeutic index. However introducing TDM will also increase costs, due to prolonged imatinib use and laboratory costs...
May 21, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31108564/the-effect-of-providing-prescribing-recommendations-on-appropriate-prescribing-a-cluster-randomized-controlled-trial-in-older-adults-in-a-preoperative-setting
#5
Marijke Nynke Boersma, Corlina Johanna Alida Huibers, Anna Clara Drenth-van Maanen, Mariëlle Henriëtte Emmelot-Vonk, Ingeborg Wilting, Wilma Knol
AIM: The 'Systematic Tool to Reduce Inappropriate Prescribing' is a method to assess patient's medication and has been incorporated into a clinical decision support system: STRIP Assistant. Our aim was to evaluate the effect of recommendations generated using STRIP Assistant on appropriate prescribing and mortality in a preoperative setting. METHODS: This cluster-randomized controlled trial was carried out at the preoperative geriatric outpatient clinic Residents who performed a comprehensive geriatric assessment were randomized to the control group and intervention group in a 1:1 ratio...
May 20, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31108563/associations-of-hla-genotypes-with-antithyroid-drug-induced-agranulocytosis-a-systematic-review-and-meta-analysis-of-pharmacogenomics-studies
#6
REVIEW
Wei-Ti Chen, Ching-Chi Chi
AIM: Antithyroid drug (ATD)-induced agranulocytosis is a life-threatening adverse drug reaction. Previous studies suggested HLA genotypes may play an important role in ATD-induced agranulocytosis. To examine the associations between HLA genotypes and ATD-induced agranulocytosis, we conducted a systematic review and meta-analysis of pharmacogenomics studies. METHODS: We searched the MEDLINE, Embase, and CENTRAL on 16 June 2018 for case-control studies on the associations between HLA genotypes with ATD-induced agranulocytosis...
May 20, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077437/comparison-of-pharmacokinetics-and-the-exposure-response-relationship-of-dapagliflozin-between-adolescent-young-adult-and-adult-patients-with-type-1-diabetes-mellitus
#7
D Busse, W Tang, M F Scheerer, T Danne, T Biester, V Sokolov, D W Boulton, J Parkinson
AIMS: To quantitatively compare pharmacokinetics (PK) and the exposure-response relationship of the sodium-glucose cotransporter-2 inhibitor, dapagliflozin, between adolescents/young adults and adults with type 1 diabetes mellitus (T1DM). METHODS: Data from two clinical studies for dapagliflozin were analysed using a non-linear mixed-effects approach. The PK and the relationship between dapagliflozin exposure and response (24-h urinary glucose excretion [UGE]) were characterised...
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077432/randomized-study-of-individualized-pharmacokinetically-guided-dosing-of-paclitaxel-compared-with-body-surface-area-dosing-in-chinese-patients-with-advanced-non-small-cell-lung-cancer
#8
Jie Zhang, Fei Zhou, Huiwei Qi, Huijuan Ni, Qiong Hu, Caicun Zhou, Yunying Li, Irina Baburina, Jodi Courtney, Salvatore J Salamone
AIMS: This prospective, randomized study was initiated to assess the impact of pharmacokinetically (PK)-guided paclitaxel (PTX) dosing on toxicity and efficacy compared with body-surface area (BSA)-based dosing in Chinese NSCLC patients. METHODS: 319 stage IIIB/IV NSCLC patients receiving first-line chemotherapy were enrolled. Patients were randomized to receive 3-weekly carboplatin plus PTX at a starting dose of 175 mg/m2 with subsequent PTX dosing based on either BSA or PK-guided dosing targeting a PTXTc>0...
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077431/a-systematic-review-of-patient-reported-outcomes-associated-with-the-use-of-direct-acting-oral-anticoagulants
#9
REVIEW
Saima Kishvar Afzal, Syed Shahzad Hasan, Zaheer Ud-Din Babar
AIMS: Patient reported outcomes (PROs) are a distinctive method of evaluating patient's response to health care or treatment. This study aimed to analyse the impact of PROs in patients on DOAC treatment, prescribed for any indication (e.g. VTE treatment or AF) using controlled trials (CT) and real world observational studies (OS). METHODS: A systematic search of articles was conducted according to PRISMA guidelines using databases, with the last update in November 2018...
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077427/body-of-evidence-and-approaches-applied-in-the-clinical-development-program-of-fixed-dose-combinations-in-the-european-union-from-2010-2016
#10
Asbjørn Nøhr-Nielsen, Marie Louise De Bruin, Mikael Thomsen, Christian Bressen Pipper, Theis Lange, Ole Jannik Bjerrum, Trine Meldgaard Lund
AIM: To provide insights into the clinical development pathway for fixed-dose combinations (FDCs), to consider strategies, and to elucidate the path to approval by assessing the body of evidence, as summarized in the European Public Assessment Reports (EPARs). METHODS: The main resource was the EPARs for 36 FDCs, which included 239 clinical trials with 157.514 patients. The analyses focused on how prior knowledge of the active substances or combination, use of pharmacokinetic-pharmacodynamic modelling, and clinical trial design choice impact the size and strategy of the clinical development program...
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077425/therapeutic-concentration-achievement-and-allograft-survival-comparing-usage-of-conventional-tacrolimus-doses-and-cyp3a5-genotype-guided-doses-in-renal-transplantation-patients
#11
Sirirat Anutrakulchai, Cholatip Pongskul, Kittrawee Kritmetapak, Chulaporn Limwattananon, Suda Vannaprasaht
AIMS: Although CytochromeP450(CYP)3A5 gene polymorphism affects personalized tacrolimus doses, there is no consensus as to whether CYP3A5 genotypes should be determined to adjust the doses. The aims were to compare the therapeutic ranges and clinical outcomes between the conventional and genotype-guided tacrolimus doses. METHODS: This randomized controlled study compared 63 cases of the conventional tacrolimus dose group (0.1 mg/kg/day) with 62 cases of the genotype-guided doses group of 0...
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077422/statins-popularity-a-global-picture
#12
LETTER
Giuseppe Lippi, Camilla Mattiuzzi, Gianfranco Cervellin
No abstract text is available yet for this article.
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31077412/the-rationale-of-dose-response-curves-in-selecting-cancer-drug-dosing
#13
REVIEW
Jennifer H Martin, Simon Dimmitt
No abstract text is available yet for this article.
May 11, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31050833/antithrombotic-dose-some-observations-from-published-clinical-trials
#14
REVIEW
Simon B Dimmitt, Christopher N Floyd, Robin E Ferner
The clinical doses of antithrombotics - antiplatelet and anticoagulant agents - need to balance efficacy and safety. It is not clear from the published literature how the doses currently used in clinical practice have been derived from preclinical and clinical data. There are few large randomised controlled trials (RCTs) that compare outcomes with different doses versus placebo. For newer antithrombotics, RCT doses appear to have been chosen to maximise the probability of demonstrating non-inferiority when compared to established agents such as warfarin or clopidogrel...
May 3, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31050355/pharmacokinetics-exposure-efficacy-and-safety-of-obinutuzumab-in-rituximab-refractory-follicular-lymphoma-patients-in-the-gadolin-phase-iii-study
#15
Ekaterina Gibiansky, Leonid Gibiansky, Vincent Buchheit, Nicolas Frey, Michael Brewster, Günter Fingerle-Rowson, Candice Jamois
INTRODUCTION: Rituximab is standard care in a number of lymphoma subtypes, including follicular lymphoma (FL), although many patients are resistant to rituximab, or develop resistance with repeated treatment, and a high proportion relapse. Obinutuzumab is a novel anti-CD20 monoclonal antibody with improved efficacy over rituximab. It is approved for previously untreated chronic lymphocytic leukaemia (CLL), and for use with bendamustine in patients with rituximab-relapsed/refractory FL...
May 3, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31050036/severe-rosuvastatin-accumulation-with-rhabdomyolysis-due-to-drug-interactions-and-low-cardiac-output-syndrome
#16
LETTER
Marco Previsdomini, Elisa Graziano, Laurent Decosterd, Perrine Courlet, Andreas Perren, Alessandro Ceschi
No abstract text is available yet for this article.
May 3, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31046175/anticholinergic-medicines-use-among-older-adults-before-and-after-initiating-dementia-medicines
#17
Sujita W Narayan, Sallie-Anne Pearson, Melisa Litchfield, David G Le Couteur, Nicholas Buckley, Andrew J McLachlan, Helga Zoega
AIM: We investigated anticholinergic medicines use among older adults initiating dementia medicines. METHODS: We used Pharmaceutical Benefits Scheme dispensing claims to identify persons who initiated donepezil, rivastigmine, galantamine or memantine between 1 January 2013 to 30 June 2017 (after a period of ≥180 days with no dispensing of these medicines) and remained on therapy for ≥180 days (N=4393), and dispensed anticholinergic medicines in the 180 days before and after initiating dementia medicines...
May 2, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31046167/steady-state-population-pharmacokinetics-of-terizidone-and-its-metabolite-cycloserine-in-patients-with-drug-resistant-tuberculosis
#18
Mwila Mulubwa, Pierre Mugabo
AIMS: Despite terizidone being part of the second-line recommended drugs for treatment of drug-resistant tuberculosis (DR-TB), information on its pharmacokinetics is scarce. The aim of this study was to describe the steady state population pharmacokinetics (PPK) of terizidone and its primary metabolite cycloserine in patients with DR-TB and determine the effect of patient characteristics. METHODS: This clinical study involved 39 adult DR-TB patients admitted to Brewelskloof Hospital in Cape Town, South Africa for intensive treatment phase...
May 2, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31026092/pharmacodynamics-of-rituximab-on-b-lymphocytes-in-paediatric-patients-with-autoimmune-diseases
#19
Shan Pan, Huixin Yu, Ayesha Surti, Iek Cheng, Stephen D Marks, Paul A Brogan, Despina Eleftheriou, Joseph F Standing
AIMS: Rituximab is a chimeric IgG-1 monoclonal antibody that depletes B cells, aiding in the treatment of several conditions including autoimmune diseases. It is not licensed for use in children. This study aimed to quantify the B cell-related pharmacodynamics of rituximab in children with autoimmune disease. METHODS: Routine electronic health record data were collected at a large paediatric tertiary hospital in London, United Kingdom. Dosing protocols were either two 750 mg/m2 intravenous infusions of rituximab on days 1 and 15, or four 375 mg/m2 infusions on days 1, 8, 15 and 22...
April 26, 2019: British Journal of Clinical Pharmacology
https://read.qxmd.com/read/31026086/analgesic-efficacy-and-pharmacokinetics-of-epidural-oxycodone-in-pain-management-after-gynaecologic-laparoscopy-a-randomised-double-blind-active-control-double-dummy-clinical-comparison-with-intravenous-administration
#20
P Piirainen, H Kokki, B J Anderson, J A Hannam, H Hautajärvi, V-P Ranta, M Kokki
AIMS: Early pain after laparoscopy is often severe. Oxycodone is a feasible analgesic option after laparoscopy, but there are sparse data on epidural administration. The aim was to evaluate the analgesic efficacy and pharmacokinetics of a single dose of epidural oxycodone as a part of multimodal analgesia after gynaecologic laparoscopy. METHODS: Women (n=60), aged 23-71 years, undergoing elective gynaecologic laparoscopy, were administrated either epidural oxycodone 0...
April 26, 2019: British Journal of Clinical Pharmacology
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