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British Journal of Clinical Pharmacology

Nina L Barnett
Medicines optimisation is a clinician-driven, person-centred ongoing process. Pharmacists and clinical pharmacologists have medicines-related expertise to deliver medication review to optimise clinical and cost effective use of medication, aligned with patient preferences, to contribute to improved health outcomes. There is a large pharmacy workforce, directly accessible to patients, who can provide expert medicines-related care on the high street, and increasingly in General Practice and care homes settings...
April 15, 2019: British Journal of Clinical Pharmacology
Katy Moore, Mindy Magee, Heather Sevinsky, Ming Chang, Susan Lubin, Elsa Myers, Peter Ackerman, Cyril Llamoso
AIMS: Regional HIV prevalence rates are high in people with history of injection drug use, including those managed with maintenance opioids. Fostemsavir (FTR) is an oral prodrug of temsavir, a first-in-class attachment inhibitor that binds HIV-1 gp120 preventing initial HIV attachment and entry into host immune cells. Here we determine the impact of FTR on the pharmacokinetics of opioids methadone (MET) (R-, S- and total) or buprenorphine and norbuprenorphine (BUP and norBUP) when coadministered...
April 13, 2019: British Journal of Clinical Pharmacology
C Zhou, S Taylor, J Tugwood, K Simpson, G C Jayson, P Symonds, J Paul, S Davidson, K Carty, E McCartney, D Rai, C Dive, C West
BACKGROUND AND PURPOSE: There is a need for predictive and surrogate response biomarkers to support treatment with anti-angiogenic VEGF inhibitors. We aimed to identify a minimally-invasive biomarker predicting benefit from cediranib pre-treatment or early during treatment in patients with recurrent or metastatic cervical cancer. EXPERIMENTAL APPROACH: Blood samples were collected before treatment, during treatment and upon disease progression where appropriate from patients enrolled in CIRCCa, a randomised phase II trial of carboplatin and paclitaxel with or without cediranib...
April 13, 2019: British Journal of Clinical Pharmacology
Jennifer H Martin, Nicholas J Talley
No abstract text is available yet for this article.
April 13, 2019: British Journal of Clinical Pharmacology
Solène M Laville, Bénédicte Stengel, Ziad A Massy, Sophie Liabeuf
No abstract text is available yet for this article.
April 13, 2019: British Journal of Clinical Pharmacology
Robyn Laube, Ken Liu
No abstract text is available yet for this article.
April 13, 2019: British Journal of Clinical Pharmacology
Camille Riff, Jean Debord, Caroline Monchaud, Pierre Marquet, Jean-Baptiste Woillard
AIMS: Tacrolimus is a narrow therapeutic range drug that requires fine dose adjustment, for which pharmacokinetic models have been amply proposed in renal, but not in liver, transplant recipients. This study aimed to build population pharmacokinetic (POPPK) models and Bayesian estimators (BE) in adult de novo liver transplant patients receiving either the immediate-release (Prograf®, TD) or prolonged-release (Advagraf®, OD) forms to help pharmacokinetics-guided dose individualization...
April 11, 2019: British Journal of Clinical Pharmacology
Shuguang Ma, Julia Suchomel, Evelyn Yanez, Edward Yost, Xiaorong Liang, Rui Zhu, Hoa Le, Nicholas Siebers, Lori Joas, Roland Morley, Stephanie Royer-Joo, Andrea Pirzkall, Laurent Salphati, Joseph A Ware, Kari M Morrissey
AIMS: Navoximod (GDC-0919, NLG-919) is a small molecule inhibitor of indoleamine-2,3-dioxygenase 1 (IDO1), developed to treat the acquired immune tolerance associated with cancer. The primary objectives of this study were to assess navoximod's absolute bioavailability (aBA), determine the mass balance and routes of elimination of [14 C]-navoximod, and characterize navoximod's metabolite profile. METHODS: A phase 1, open-label, 2-part study was conducted in healthy volunteers...
April 11, 2019: British Journal of Clinical Pharmacology
Elias Immanuel Ordell Sundelin, Lars Christian Gormsen, Sara Heebøll, Mikkel Holm Vendelbo, Steen Jakobsen, Ole Lajord Munk, Søren Feddersen, Kim Brøsen, Stephen Jacques Hamilton-Dutoit, Steen Bønløkke Pedersen, Henning Grønbaek, Niels Jessen
AIM: Metformin is first line treatment of type 2 diabetes mellitus and reduce cardiovascular events in patients with insulin resistance and type 2 diabetes. Target tissue for metformin action is suggested to be the liver, where metformin distribution depends on facilitated transport by polyspecific transmembrane organic cation transporters (OCTs). Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with strong associations to insulin resistance and the metabolic syndrome but if NAFLD affects metformin biodistribution to the liver is not known...
April 11, 2019: British Journal of Clinical Pharmacology
Hubert G Leufkens
No abstract text is available yet for this article.
April 10, 2019: British Journal of Clinical Pharmacology
A C van der Vossen, L M Hanff, A G Vulto, N Fotaki
AIMS: This study explores the impact of paediatric patient related factors and choice of formulation on the dissolution characteristics of nifedipine and lorazepam, two drug substances regularly applied in very young patients and in compounded formulations. METHODS: Dissolution experiments were designed to reflect clinical practice in a paediatric hospital, with respect to dosage forms, feeding regimens, and methods of administration. Solubility studies addressed the influence of age and prandial state...
April 9, 2019: British Journal of Clinical Pharmacology
Jong-Mi Seong, Jeong Yee, Hye Sun Gwak
AIMS: To evaluate the real-world effect of DPP-4 inhibitor (DPP4i) on the incidence of autoimmune diseases (AD), including rheumatoid arthritis (RA), inflammatory bowel diseases (IBD), multiple sclerosis (MS), and systemic lupus erythematosus (SLE). METHODS: We identified new users of DPP4i (N=497 619) or non-DPP4i (N=643 165) oral combination therapy between 1 January 2011 and 30 June 2015 among patients with type 2 diabetes mellitus in the Korean national health insurance claims database...
April 9, 2019: British Journal of Clinical Pharmacology
Carla Bastida, Dolors Soy, Virginia Ruiz-Esquide, Raimon Sanmartí, Alwin D R Huitema
AIMS: Tocilizumab has a direct effect on inflammatory markers. Therefore, composite measures for disease activity assessment in rheumatoid arthritis (RA) using these inflammatory markers may not be suitable for tocilizumab treatment. We used a modeling approach to describe tocilizumab exposure-response relationship and to investigate the different dynamics of the individual components of the routinely used continuous composite measures. METHODS: Pharmacokinetic (PK), clinical and laboratory data were obtained from a prospective, observational, single-center study involving 35 subjects with RA treated with intravenous tocilizumab...
April 8, 2019: British Journal of Clinical Pharmacology
Zheng Lu, Peter Bonate, James Keirns
AIMS: Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf™) and/or once-daily, prolonged-release (PR-T; Advagraf™ or Astagraf XL™) tacrolimus. METHODS: Tacrolimus concentration-time profiles were analyzed from eight Phase II studies in adult and pediatric liver, kidney, and heart transplant patients receiving IR-T and/or PR-T. A tacrolimus population pharmacokinetic model, including identification of significant covariates, was developed using NONMEM...
April 4, 2019: British Journal of Clinical Pharmacology
Matthew T Drake, Serge Cremers, R Graham Russell, John P Bilezikian
No abstract text is available yet for this article.
April 4, 2019: British Journal of Clinical Pharmacology
John B Warren
When choosing a medicine two aspects determine the balance between benefit and harm (risk-benefit), matching the medicine to the individual and the choice of dose. Knowing the relationship between dose and response allows a calculation of the dose that causes 50% of the maximal effect, the ED50 . Rational drug dosing depends on defining the ratio of the dose to the ED50 . The ED50 of each drug has two scales, whether the effect measured is for efficacy, or safety. Quantifying efficacy is comparatively straightforward...
April 3, 2019: British Journal of Clinical Pharmacology
Anna Svedberg, Svante Vikingsson, Anders Vikström, Niels Hornstra, Magnus Kentson, Eva Branden, Hirsh Koyi, Bengt Bergman, Henrik Gréen
AIM: Erlotinib is a tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer highly metabolized by the cytochrome P450 (CYP) 3A. Hence, the CYP3A4 activity might be a useful predictor for erlotinib pharmacokinetics in personalized medicine. The effect of erlotinib on CYP3A activity was therefore studied in non-small cell lung cancer patients. METHODS: The study included 32 patients scheduled for erlotinib monotherapy. CYP3A activity was assessed using quinine as a probe before and during erlotinib treatment...
April 3, 2019: British Journal of Clinical Pharmacology
S T de Vries, P Denig, C Ekhart, J S Burgers, N Kleefstra, P G M Mol, E P van Puijenbroek
AIMS: We aimed to assess and characterize gender differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while taking into account differences in drug use. METHODS: ADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug-ADR combinations reported at least 10 times between 2003-2016 for drugs used by ≥10,000 persons in that period were included...
April 2, 2019: British Journal of Clinical Pharmacology
Ariane Schenk, Rahel Eckardt-Felmberg, Elisabeth Steinhagen-Thiessen, Sven Stegemann
AIMS: Adequate medication management is a key condition to ensuring effective pharmacotherapy. However, it is well acknowledged that older people may encounter difficulties self-administering medicines in a correct manner. METHODS: A mixed method pilot study was performed to investigate medication self-management in older and multimorbid patients with polypharmacy. The pilot study involved medication management tasks followed by semi-structured interviews in 20 patients...
April 1, 2019: British Journal of Clinical Pharmacology
Tuukka A Helin, Lotta Joutsi-Korhonen, Heidi Asmundela, Mikko Niemi, Arto Orpana, Riitta Lassila
AIMS: Warfarin dose requirement varies significantly. We compared the clinically established international normalized ratio (INR) -based doses among patients with severe thrombosis and/or thrombophilia with estimates from genetic dosing algorithms. METHODS: Fifty patients with severe thrombosis and/or thrombophilia requiring permanent anticoagulation, referred to the Helsinki University Hospital Coagulation Center, were screened for thrombophilias and genotyped for CYP2C9*2 (c...
April 1, 2019: British Journal of Clinical Pharmacology
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