abstract：AIMS:Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety war...

journal_title：British journal of clinical pharmacology

authors： Lexchin J

更新日期：2015-05-01 00:00:00

abstract：AIMS:To compare gastric acid suppression by netazepide, a gastrin/CCK2 receptor antagonist, with that by a proton pump inhibitor (PPI), and to determine if netazepide can prevent the trophic effects of PPI-induced hypergastrinaemia. METHODS:Thirty healthy subjects completed a double-blind, randomized, parallel group t...

journal_title：British journal of clinical pharmacology

authors： Boyce M,Dowen S,Turnbull G,van den Berg F,Zhao CM,Chen D,Black J

更新日期：2015-05-01 00:00:00

abstract：:The oral delivery of peptides and proteins has been hampered by an array of obstacles. However, several promising novel oral delivery systems have been developed. This paper reviews the most advanced oral formulation technologies, and highlights key lessons and implications from studies undertaken to date with these o...

journal_title：British journal of clinical pharmacology

authors： Karsdal MA,Riis BJ,Mehta N,Stern W,Arbit E,Christiansen C,Henriksen K

更新日期：2015-05-01 00:00:00

abstract：AIM:Drug-drug interactions between antimalarial and antiretroviral drugs may influence antimalarial treatment outcomes. The aim of this study was to investigate the potential drug-drug interactions between the antimalarial drugs, lumefantrine, artemether and their respective metabolites desbutyl-lumefantrine and dihydr...

journal_title：British journal of clinical pharmacology

authors： Hoglund RM,Byakika-Kibwika P,Lamorde M,Merry C,Ashton M,Hanpithakpong W,Day NP,White NJ,Äbelö A,Tarning J

更新日期：2015-04-01 00:00:00

abstract：AIMS:To establish the dose-response for pharmacodynamics (bronchodilatation), safety and pharmacokinetics for a nebulized formulation of the long acting muscarinic antagonist glycopyrrolate (EP-101) with a high efficiency nebulizer in patients with chronic obstructive pulmonary disease (COPD). METHODS:Patients with mo...

journal_title：British journal of clinical pharmacology

authors： Leaker BR,Barnes PJ,Jones CR,Tutuncu A,Singh D

更新日期：2015-03-01 00:00:00

abstract：AIMS:The inhaled allergen challenge model has been used previously to investigate the effects of novel anti-inflammatory drugs in inhaled corticosteroid (ICS)-naïve asthmatics. The aim of this study was to characterize high- and low-dose allergen challenges in asthmatic patients using ICS. METHODS:Twenty-eight asthmat...

journal_title：British journal of clinical pharmacology

authors： Lee WY,Southworth T,Booth S,Singh D

更新日期：2015-03-01 00:00:00

abstract：:The evolution of human immunodeficiency virus (HIV) treatment has improved our understanding and management of complex pharmacological issues that have driven improved outcomes and quality of life of the HIV-infected patient. These issues include adherence, long- and short-term toxicities, pharmacoenhancement, pharmac...

journal_title：British journal of clinical pharmacology

authors： Tseng A,Seet J,Phillips EJ

更新日期：2015-02-01 00:00:00

abstract：AIM:We aimed to establish a method to assess systemic and pre-systemic cytochrome P450 (CYP) 3A activity using ineffective microgram doses of midazolam. METHODS:In an open, one sequence, crossover study, 16 healthy participants received intravenous and oral midazolam at microgram (0.001 mg intravenous and 0.003 mg ora...

journal_title：British journal of clinical pharmacology

authors： Hohmann N,Kocheise F,Carls A,Burhenne J,Haefeli WE,Mikus G

更新日期：2015-02-01 00:00:00

abstract：:Infections due to resistant and multidrug resistant (MDR) organisms in haematology patients and haematopoietic stem cell transplant recipients are an increasingly complex problem of global concern. We outline the burden of illness and epidemiology of resistant organisms such as gram-negative pathogens, vancomycin-resi...

journal_title：British journal of clinical pharmacology

authors： Trubiano JA,Worth LJ,Thursky KA,Slavin MA

更新日期：2015-02-01 00:00:00

abstract：AIMS:The main goal of the study was to describe the pharmacokinetics of maternal zidovudine (ZDV) administration during pregnancy and labour and to evaluate their impact on fetal concentrations and exposures. METHODS:A total of 195 HIV-infected pregnant and non-pregnant women aged 16-59 years were included and 273 mat...

journal_title：British journal of clinical pharmacology

authors： Fauchet F,Treluyer JM,Valade E,Benaboud S,Pannier E,Firtion G,Foissac F,Bouazza N,Urien S,Hirt D

更新日期：2014-12-01 00:00:00

abstract：AIM:This study aims to investigate the clinical and demographic factors influencing gentamicin pharmacokinetics in a large cohort of unselected premature and term newborns and to evaluate optimal regimens in this population. METHODS:All gentamicin concentration data, along with clinical and demographic characteristics...

journal_title：British journal of clinical pharmacology

authors： Fuchs A,Guidi M,Giannoni E,Werner D,Buclin T,Widmer N,Csajka C

更新日期：2014-11-01 00:00:00

abstract：AIMS:Variability in responsiveness to clopidogrel is a clinical problem in secondary prevention after cerebral ischaemia which has been suggested to be linked to competitive metabolization of clopidogrel and cytochrome P450 (CYP) 3A4-oxidated statins such as simvastatin. We assessed the hypothesis that simvastatin, in ...

journal_title：British journal of clinical pharmacology

authors： Siepmann T,Heinke D,Kepplinger J,Barlinn K,Gehrisch S,Grählert X,Schwanebeck U,Reichmann H,Puetz V,Bodechtel U,Gahn G

更新日期：2014-11-01 00:00:00

abstract：AIMS:Our goal was to evaluate the association between antidepressant use and the risk of coronary heart disease (CHD) among subjects with no history of coronary heart disease. METHODS:A search of Medline, EMBASE, PsycINFO and the Cochrane Library was performed in January 2013. Two authors independently reviewed and se...

journal_title：British journal of clinical pharmacology

authors： Oh SW,Kim J,Myung SK,Hwang SS,Yoon DH

更新日期：2014-10-01 00:00:00

abstract：AIMS:Paraquat poisoning is a medical problem in many parts of Asia and the Pacific. The mortality rate is extremely high as there is no effective treatment. We analyzed data collected during an ongoing cohort study on self-poisoning and from a randomized controlled trial assessing the efficacy of immunosuppressive ther...

journal_title：British journal of clinical pharmacology

authors： Wunnapuk K,Mohammed F,Gawarammana I,Liu X,Verbeeck RK,Buckley NA,Roberts MS,Musuamba FT

更新日期：2014-10-01 00:00:00

abstract：AIMS:Although genetic, clinical and demographic factors have been shown to explain approximately half of the inter-individual variability in warfarin dose requirement in adults, less is known about causes of dose variability in children. This study aimed to identify and quantify major genetic, clinical and demographic ...

journal_title：British journal of clinical pharmacology

authors： Hamberg AK,Wadelius M,Friberg LE,Biss TT,Kamali F,Jonsson EN

更新日期：2014-07-01 00:00:00

abstract：AIM:We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here 'BZD') use. METHODS:A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) w...

journal_title：British journal of clinical pharmacology

authors： Lähteenmäki R,Puustinen J,Vahlberg T,Lyles A,Neuvonen PJ,Partinen M,Räihä I,Kivelä SL

更新日期：2014-06-01 00:00:00

abstract：AIM:Lamivudine is used as first line therapy in HIV-infected children. Yet, like many other paediatric drugs, its dose rationale has been based on limited clinical data, without thorough understanding of the effects of growth on drug disposition. Here we use lamivudine to show how a comprehensive population pharmacokin...

journal_title：British journal of clinical pharmacology

authors： Piana C,Zhao W,Adkison K,Burger D,Jacqz-Aigrain E,Danhof M,Della Pasqua O

更新日期：2014-05-01 00:00:00

abstract：:Individual and population differences in polymorphic cytochrome P450 enzyme function have been known for decades. The biological significance of these differences has now been deciphered with regard to drug metabolism, action and toxicity as well as disposition of endogenous substrates, including neuroactive compounds...

journal_title：British journal of clinical pharmacology

authors： Peñas-Lledó EM,Llerena A

更新日期：2014-04-01 00:00:00

abstract：:Catechol-O-methyltransferase (COMT) is of great importance in pharmacology because it catalyzes the metabolism (methylation) of endogenous and xenobiotic catechols. Moreover, inhibition of COMT is the drug target in the management of central nervous system (CNS) disorders such as Parkinson's disease due to its role in...

journal_title：British journal of clinical pharmacology

authors： Ma Z,Liu H,Wu B

更新日期：2014-03-01 00:00:00

abstract：:For people seeking treatment, the course of heroin addiction tends to be chronic and relapsing, and longer duration of treatment is associated with better outcomes. Heroin addiction is strongly associated with deviant behaviour and crime, and the objectives in treating heroin addiction have been a blend of humane supp...

journal_title：British journal of clinical pharmacology

authors： Bell J

更新日期：2014-02-01 00:00:00

abstract：AIMS:Prescribing errors are common and inadequate preparation of prescribers appears to contribute. A junior doctor-led prescribing tutorial programme has been developed for Edinburgh final year medical students to increase exposure to common prescribing tasks. The aim of this study was to assess the impact of these tu...

journal_title：British journal of clinical pharmacology

authors： Gibson KR,Qureshi ZU,Ross MT,Maxwell SR

更新日期：2014-01-01 00:00:00

abstract：AIMS:To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. METHODS:We analysed quarterly primary care total and quinine prescribing data for England and quinine prescribing volu...

journal_title：British journal of clinical pharmacology

authors： Acheampong P,Cooper G,Khazaeli B,Lupton DJ,White S,May MT,Thomas SH

更新日期：2013-12-01 00:00:00

abstract：AIMS:Rifampicin profoundly reduces lopinavir concentrations. Doubled doses of lopinavir/ritonavir compensate for the effect of rifampicin in adults, but fail to provide adequate lopinavir concentrations in young children on rifampicin-based antituberculosis therapy. The objective of this study was to develop a populati...

journal_title：British journal of clinical pharmacology

authors： Zhang C,Denti P,Decloedt EH,Ren Y,Karlsson MO,McIlleron H

更新日期：2013-11-01 00:00:00

abstract：:Exposure-response (ER) analysis has emerged as an important tool to interpret QT data from thorough QT (TQT) studies and allows the prediction of effects in the targeted patient population. Recently, ER analysis has also been applied to data from early clinical pharmacology studies, such as single and multiple ascendi...

journal_title：British journal of clinical pharmacology

authors： Darpo B,Garnett C

更新日期：2013-11-01 00:00:00

abstract：AIMS:To evaluate the comparative efficacy (50% reduction in seizure frequency) and tolerability (premature withdrawal due to adverse events) of anti-epileptic drugs (AEDs) for refractory epilepsy. METHODS:We searched Cochrane Central Register of Controlled Trials (Cochrane Library 2009, issue 2) including Epilepsy Gro...

journal_title：British journal of clinical pharmacology

authors： Bodalia PN,Grosso AM,Sofat R,Macallister RJ,Smeeth L,Dhillon S,Casas JP,Wonderling D,Hingorani AD

更新日期：2013-11-01 00:00:00

abstract：:Small GTPases of the Rho family and their down-stream effectors Rho associated kinases (ROCKs) are the molecules that converge a spectrum of pathophysiological signals triggered by the diabetic milieu and represent promising molecular targets for nephroprotective treatment in diabetes. The review discusses recent stud...

journal_title：British journal of clinical pharmacology

authors： Komers R

更新日期：2013-10-01 00:00:00

abstract：AIMS:The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. METHODS:To identify a generic way to structure the drug administration process we performed peer-group dis...

journal_title：British journal of clinical pharmacology

authors： Seidling HM,Lampert A,Lohmann K,Schiele JT,Send AJ,Witticke D,Haefeli WE

更新日期：2013-09-01 00:00:00

abstract：:The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to en...

journal_title：British journal of clinical pharmacology

authors： Jones DR,McBlane JW,McNaughton G,Rajakumaraswamy N,Wydenbach K

更新日期：2013-08-01 00:00:00

abstract：:Imagine a medicine that is expected to have very limited effects based upon knowledge of its pharmacology and (patho)physiology and that is studied in the wrong population, with low-quality studies that use a surrogate end-point that relates to the clinical end-point in a partial manner at most. Such a medicine would ...

journal_title：British journal of clinical pharmacology

authors： Heuberger JA,Cohen Tervaert JM,Schepers FM,Vliegenthart AD,Rotmans JI,Daniels JM,Burggraaf J,Cohen AF

更新日期：2013-06-01 00:00:00

abstract：AIM:The large inter-individual variability in clopidogrel response is attributed to pharmacokinetics. Although, it has been used since the late 1990s the pharmacokinetic fate of clopidogrel and its metabolites are poorly explained. The variable response to clopidogrel is believed to be multi-factorial, caused both by g...

journal_title：British journal of clinical pharmacology

authors： Ganesan S,Williams C,Maslen CL,Cherala G

更新日期：2013-06-01 00:00:00

abstract：AIM:To characterize the romiplostim dose-response in subjects with low or intermediate-1 risk myelodysplastic syndromes (MDS) receiving subcutaneous romiplostim. METHODS:Data from 44 MDS subjects receiving subcutaneous romiplostim (dose range 300-1500 μg week(-1) ) were used to develop a pharmacodynamic model consisti...

journal_title：British journal of clinical pharmacology

authors： Perez Ruixo JJ,Doshi S,Wang YM,Mould DR

更新日期：2013-06-01 00:00:00

abstract：AIM:To examine comprehensively the relationship between exposure to four classes of psychotropic drugs including antipsychotics, antidepressants, benzodiazepines (BZDs) and Z-drugs, and motor vehicle accidents (MVAs). METHOD:The authors conducted a matched case-control study of 5183 subjects with MVAs and 31 093 match...

journal_title：British journal of clinical pharmacology

authors： Chang CM,Wu EC,Chen CY,Wu KY,Liang HY,Chau YL,Wu CS,Lin KM,Tsai HJ

更新日期：2013-04-01 00:00:00

abstract：AIM:To investigate the effect of the P-glycoprotein inhibitor verapamil on the pharmacokinetics and pharmacodynamics of dabigatran etexilate (DE). METHOD:In this two part multiple crossover trial in 40 healthy subjects, DE 150 mg was given alone or with verapamil at different doses, duration of treatment (single vs. m...

journal_title：British journal of clinical pharmacology

authors： Härtter S,Sennewald R,Nehmiz G,Reilly P

更新日期：2013-04-01 00:00:00

abstract：:Metabolomics is recognized as a powerful top-down system biological approach to understand genetic-environment-health paradigms paving new avenues to identify clinically relevant biomarkers. It is nowadays commonly used in clinical applications shedding new light on physiological regulatory processes of complex mammal...

journal_title：British journal of clinical pharmacology

authors： Collino S,Martin FP,Rezzi S

更新日期：2013-03-01 00:00:00

abstract：:Osteoporosis is a skeletal disease characterized by a decrease in bone mass and bone quality that predispose an individual to an increased risk of fragility fractures. Evidence demonstrating a positive link between certain dietary patterns (e.g. Mediterranean diet or high consumption of fruits and vegetables) and bone...

journal_title：British journal of clinical pharmacology

authors： Sacco SM,Horcajada MN,Offord E

更新日期：2013-03-01 00:00:00

abstract：AIM:Characterization of the biliary disposition of GSK1325756, using a non-invasive bile sampling technique and spectrometric analyses, to inform the major routes of metabolic elimination and to enable an assessment of victim drug interaction risk. METHOD:Sixteen healthy, elderly subjects underwent non-invasive bile c...

journal_title：British journal of clinical pharmacology

authors： Bloomer JC,Nash M,Webb A,Miller BE,Lazaar AL,Beaumont C,Guiney WJ

更新日期：2013-02-01 00:00:00

abstract：AIM:Propylene glycol (PG) is often applied as an excipient in drug formulations. As these formulations may also be used in neonates, the aim of this study was to characterize the pharmacokinetics of propylene glycol, co-administered intravenously with paracetamol (800 mg PG/1000 mg paracetamol) or phenobarbital (700 mg...

journal_title：British journal of clinical pharmacology

authors： De Cock RF,Knibbe CA,Kulo A,de Hoon J,Verbesselt R,Danhof M,Allegaert K

更新日期：2013-01-01 00:00:00

abstract：:Clinical studies comparing the response and side effects of various opioids have not been able to show robust differences between drugs. Hence, recommendations of the regulatory authorities have been driven by costs with a general tendency in many countries to restrict physician's use of opioids to morphine. Although ...

journal_title：British journal of clinical pharmacology

authors： Drewes AM,Jensen RD,Nielsen LM,Droney J,Christrup LL,Arendt-Nielsen L,Riley J,Dahan A

更新日期：2013-01-01 00:00:00

abstract：WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT:Venous thromboembolism is a frequent complication in critically ill patients that has a negative impact on patient outcomes. Critically ill patients have significantly lower plasma anti-factor-Xa activity levels compared with control patients after administration of subcutaneous...

journal_title：British journal of clinical pharmacology

authors： Gouya G,Palkovits S,Kapiotis S,Madl C,Locker G,Stella A,Wolzt M,Heinz G

更新日期：2012-11-01 00:00:00

abstract：:A review of all medication incidents reported to the National Reporting and Learning System (NRLS) in England in Wales between 1 January 2005 and 31 December 2010 was undertaken. The 526,186 medication incident reports represented 9.68% of all patient safety incidents. Medication incidents from acute general hospitals...

journal_title：British journal of clinical pharmacology

authors： Cousins DH,Gerrett D,Warner B

更新日期：2012-10-01 00:00:00