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Clinical Pharmacology - Science topic

Clinical Pharmacology and Clinical Therapeutics
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Publications related to Clinical Pharmacology (10,000)
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Background The small patient populations inherent to rare genetic diseases present many challenges to the traditional drug development paradigm. One major challenge is generating sufficient data in early phase studies to inform dose selection for later phase studies and dose optimization for clinical use of the drug. However, optimizing the benefit...
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Background Therapeutic drug monitoring (TDM) may represent an invaluable tool for optimizing antimicrobial therapy in septic patients, but extensive use is burdened by barriers. The aim of this study was to assess the impact of a newly established expert clinical pharmacological advice (ECPA) program in improving the clinical usefulness of an alrea...
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Introduction: Lisdexamfetamine dimesylate (LDX) is a prodrug approved for attention deficit / hyperactivity disorder and for moderate-to-severe binge eating disorder in adults in some countries. Area covered: We aimed to specify the abuse potential of LDX in adults, using a review of pharmacokinetic/pharmacodynamic (PK/PD), animal, clinical, and ph...
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Linezolid is an oxazolidinone antibacterial drug, and its therapeutic drug monitoring and individualized treatment have been challenged since its approval. With the in-depth clinical research of linezolid, we have changed our attitude toward its therapeutic drug monitoring and our view of individualized treatment. On the basis of summarizing the ex...
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This study compared the bioavailability of two pimitespib formulations (Formulations A and B), evaluated the food effect on Formulation A, and evaluated the safety and efficacy of multiple pimitespib doses in patients with solid tumors. This clinical, pharmacological multicenter study had two cohorts and periods. A single dose of Formulation A or B...
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Panax quinquefolius L. has attracted extensive attention worldwide because of its prominent pharmacological properties on type 2 diabetes, cancers, central nervous system, and cardiovascular diseases. Ginsenosides are active phytochemicals of P. quinquefolius, which can be classified as propanaxdiol (PPD)-type, propanaxtriol (PPT)-type, oleanane-ty...
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Objective: The extent, range, and nature of available research in the field of herbal therapies for osteoarthritis (OA) have not been systematically analyzed. This study aimed to map the literature available on herbal therapies for OA and identify global hotspots and trends in this field. Methods: Studies on herbal therapies for OA published bet...
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Scope, historical overview and perspectives: Athineos Philippu, Department of Pharmacology and Toxicology, University of Innsbruck, Austria The eighth pharmacologic-historical Forum was held online in 2022 in Bonn during the Meeting of the DGPT. In this forum the personalities of Hans Dengler, Paul Martini, Manfred Göthert, and Rudolf Buchheim wer...
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Purpose Therapeutic drug monitoring (TDM) is widely recognised as a key attribute of clinical pharmacologists; yet, the extent to which physicians undertaking postgraduate training in clinical pharmacology (hereafter trainees) are involved in TDM is poorly characterised. Our own experience suggests wide variation in trainee exposure to TDM. Method...
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Clozapine is the gold standard for treatment-resistant schizophrenia. Serious and even life-threatening adverse effects, mostly granulocytopenia, myocarditis, and constipation, are of great clinical concern and constitute a barrier to prescribing clozapine, thus depriving many eligible patients of a lifesaving treatment option. Interestingly, cloza...
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Introduction Time-varying exposure is an important issue that should be addressed in longitudinal observational studies using routinely collected data (RCD) for drug treatment effects. How well investigators designed, analysed and reported time-varying exposure, and to what extent the divergence that can be observed between different methods used f...
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A wide inter-individual variability in the therapeutic response to cyclin-dependent kinases 4 and 6 inhibitors (CDKis) has been reported. We herein present a case series of five patients treated with either palbociclib or ribociclib referred to our clinical pharmacological counselling, including therapeutic drug monitoring (TDM), pharmacogenetics,...
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Although 23 antiretroviral drugs are approved for use in adults, only six are approved by regulatory authorities for use in term neonates born to women with HIV, with even fewer options for preterm neonates. A major hurdle for approvals is the delay in the generation of pharmacokinetic and safety data for antiretrovirals in neonates. The median tim...
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In neonates, pharmacogenetics has an additional layer of complexity. This is because in addition to genetic variability in genes that code for proteins relevant to clinical pharmacology, there are rapidly maturational changes in these proteins. Consequently, pharmacotherapy in neonates has unique challenges. To provide a contemporary overview on ph...
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Background To date, no study has identified a clear relationship between drug and a specific clinical presentation of DRESS. Objectives To investigate the particularities of DRESS and analyze the variation of DRESS pattern according to culprit drugs. Methods We analyzed cases of DRESS notified to the Department of Clinical Pharmacology at the Uni...
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Objective: The objective of the study was to evaluate the drug-drug interaction studies of Levocetirizine with Losartan potassium Methodology: Calibration curve studies of working standard solutions of Levocetirizine and Losartan potassium (0.01-0.1 m Mole) were scanned. Maxima appeared at 231nm for Levocetirizine and 205 nm for Losartan potassium....
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Background: An increasing number of studies on dexmedetomidine use in adults have been published, but the effectiveness of dexmedetomidine remains contentious. Objective: This study aimed to describe the changing trends and structural relationships of scientific achievements regarding dexmedetomidine over the past 2 decades and provide researche...
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the extremities were in greater evidence. These injuries are characterized by high-energy and comminuted fractures, vascular damage and important soft tissue loss. More recently, in the Global War Against Terrorism, reports from the United States Navy Medical Corps revealed an incidence of 58 to 88% of firearm injuries, with 23 to 39% of fractures...
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Background The thiopurine medications are well established in the treatment of inflammatory bowel disease (IBD). There is significant variation in levels of toxic and therapeutic metabolites. Current data from small or short-term studies support therapeutic drug monitoring (TDM) in assessing azathioprine (AZA) and 6-mercaptopurine (6MP). TDM of thi...
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Iodinated- (ICM) and gadolinium-based (GCM) contrast media are used in radiology imaging techniques, such as computer tomography (CT) and magnetic resonance (MR), respectively. The paper aims to analyze the adverse drug reactions of ICM and GCM on different sites of the body in a highly polluted environment. We analyzed the pharmacovigilance in con...
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Background Lipoprotein (a)–Lp(a) has proinflammatory, prothrombotic and proatherogenic properties and may theoretically influence the course of COVID-19. Objectives The aim of the study was to explore whether patients hospitalized due to COVID-19 with Lp(a) ≥30mg/dl may develop a worse course of the disease, increased incidence of thromboembolic c...
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Tumor escape mechanisms for immunotherapy include deficiencies in antigen presentation, diminishing adaptive CD8+ T cell antitumor activity. Although innate natural killer (NK) cells are triggered by loss of MHC class I, their response is often inadequate. To increase tumor susceptibility to both innate and adaptive immune elimination, we performed...
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The lockdown measures imposed to stop the spread of the virus have affected the general population, but particularly people with chronic diseases such as diabetes. An observational real world data pre-post study of 86,615 individuals over the age of 16, having a medical history in the Aragon (Spain) Health Service and diagnosed with diabetes, witho...
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The modular operating theater (MOT) system is often used in operating rooms since it is incorporated into a single control panel, enabling its operation more effectively and efficiently. The MOT in the present study's operating room employs analytical techniques, and moreover has complicated space needs. Any hospital that wants to implement MOT in...
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Introduction Postnatal steroids during the first few weeks of life have been demonstrated to be effective in decreasing the incidence of bronchopulmonary dysplasia (BPD), a serious chronic respiratory condition affecting preterm infants. However, this preventive option is limited by the concern of neurological side effects. Steroids are used to tre...
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Objective To investigate the admission rate to neonatal care and neonatal morbidity after maternal use of antipsychotics during pregnancy. Design A population-based register study. Setting Information on all singleton births between July 2006 and December 2017 in Sweden including data on prescription drugs, deliveries and infants’ health was obta...
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Introduction Multiple myeloma (MM) is an incurable malignant neoplasm that accounts for approximately 1% of all cancers and 10% of haematological malignancies. Bortezomib is one of the most commonly used medications in first-line treatment and subsequent relapses, either as a single agent or in combination with other therapies. This study aims to a...
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Objectives To describe the incidence of adverse events (AEs), reactogenicity symptoms, menstrual changes and overall self-rated improvement in health and well-being after COVID-19 vaccination. Design VAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease...
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Increasing clinical data on sex-related differences in drug efficacy and toxicity has highlighted the importance of understanding the impact of sex on drug pharmacokinetics and pharmacodynamics. Intrinsic differences between males and females, such as different CYP enzyme activity, drug transporter expression or levels of sex hormones can all contr...
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Diazepam-based drugs are widely used today in human treatment. Diazepam may be a primary drug aimed at treating neurological diseases or an associated drug in the treatment of other diseases in the purpose of symptomatic therapy. The sedative effect of diazepam characterizes it as a drug that people usually use on their own and without a doctor’s s...
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In medical studies, pharmacology is a subject with a high teaching and study load. The COVID-19 pandemic–related switch to distance learning implies challenges for students and teachers. To identify changes of behavior, attitudes, and needs among students and teachers in clinical pharmacology during the pandemic, regular surveys were conducted at U...
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Introduction: In human pharmacology, there are two important scientific branches: clinical pharmacology and pharmacoepidemiology. Pharmacokinetic/pharmacodynamic (PK/PD) modeling is important in preclinical studies and randomized control trials. However, it is rarely used in pharmacoepidemiological studies on the effectiveness and medication safety...
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Objectives To determine whether hydroxychloroquine when used with personal protective equipment reduces the proportion of laboratory-confirmed COVID-19 among healthcare workers in comparison to the use of personal protective equipment alone. Design Multicentre, parallel-group, open-label randomised trial. Enrolment started on 29 June 2020 and stop...
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Purpose: Magnetic iron oxide nanoparticle (MNP) drug delivery system is a novel promising therapeutic option for cancer treatment. Material issues such as fabrication and functionalized modification have been investigated; however, pharmacologic mechanisms of bare MNPs inside cancer cells remain obscure. This study aimed to explore a systems pharm...
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Filgotinib (GS-6034, formerly GLPG0634; Jyseleca®) is an oral, preferential Janus kinase (JAK)-1 inhibitor. Preferential inhibition of JAK1 modulates a subset of proinflammatory cytokines within the JAK–signal transducer and activator of transcription pathway, which differ from those inhibited by JAK2 or JAK3. Filgotinib is absorbed extensively and...
Preprint
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Seminar paper on Croatian language for postgraduate specialist study program for clinical pharmacology and toxicology: analysis of a study results. Peer-reviewed by a senior colleague.
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The main risk factors for CHD and the comorbidity include hyperlipidemia (HL), hypertension, smoking, dietary factors, and genetic factors. In this work, 215 patients with coronary heart disease, including 128 males and 87 females, were analyzed for a better understanding of the related clinical pharmacology. Nonparametric test, analysis of varianc...
Chapter
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Genética (do grego “genétikós”) significa “capaz de gerar”, indicando o seu papel na gênese da vida. A Genética é a ciência que estuda os genes, a hereditariedade e a transmissão de caracteres através das gerações. Durante o século XIX, essa ciência evoluiu significativamente a partir dos experimentos de Gregor Mendel com as ervilhas, que resultou...
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Non‐steroidal anti‐inflammatory drugs (NSAIDs) inhibit the enzyme cyclooxygenase (COX) which forms prostaglandins involved in pain and inflammation. COX‐inhibitors have analgesic and anti‐inflammatory effects, but also increased risks for gastrointestinal ulcers, bleeding, and renal and cardiovascular adverse events. Identification of two isoforms...
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Background Mucins are part of the glycoprotein family and the main proteinaceous component of mucus. The sea anemone species, Actinia tenebrosa (Phylum Cnidaria) produce large amounts of mucus, which have not been studied in detail. Furthermore, there has only been limited investigation of mucin genes in phylum Cnidaria. Therefore, the aim of curre...
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Bendamustine is an alkylating agent classified into the group of nitrogen mustard analogues, synthesized almost sixty years ago. It was registered in former East Germany in 1971 and approved by the US Food and Drug Administration in 2008 for treatment of chronic lymphocytic leukemia and indolent B‑cell non‑Hodgkin lymphoma. Considering its benefici...
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Objectives To assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D). Design Open-label, 24-week, prospective cohort study. Setting 65 secondary care diabetes centres in Romania. Participants The study included 901 adults with T2D subo...
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Pharmacometrics and the application of population pharmacokinetic (PK) modeling play a crucial role in clinical pharmacology. These methods, which describe data with well‐defined equations and estimate physiologically interpretable parameters, have not changed substantially during the past decades. Although the methods have proven their usefulness,...
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For many years, clinical pharmacology (CP) has been taught at schools of medicine via traditional methods including classic lectures and experimental sessions. The explosion of scientific knowledge and the availability of many treatment options have necessitated the development of new strategies for pharmacology teaching and learning. Applying info...
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For a long time, clinical pharmacology (CP) has been educated at schools of medication through customary techniques including exemplary talks and trial meetings. The blast of logical information and the accessibility of numerous treatment choices have required the improvement of new techniques for pharmacology educating and learning. Applying data...
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The functioning of the frontal lobes is related to executive functions, which are human high order mental functions. These functions are altered in major depressive disorder (MDD) and may alter the daily living activities of patients. We conducted a neuropsychological testing of frontal lobes with a group of pharmacological treated outpatients with...
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This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. Coronavirus 2019 (C...
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Invasive fungal infections in various categories of patients remain one of the most urgent problems of modern medicine. This is complicated by the imperfection of diagnostic methods, as well as a small range of antimycotics for systemic use. The market launch in 2005 of posaconazole, a second-generation systemic antimycotic from the group of triazo...
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Background: Several investigations have confirmed changes in lipid profiles and other markers (interleukin [IL]-6, C-reactive protein [CRP]) in women with pregnancy induced hypertension (PIH). Although, the cause an effect correlations between these lipid profiles and other markers with the PIH are yet unknown. Aim: To study the relationship of...
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Introduction: Antibiotic resistance is one of the most pressing health threats that mankind faces now and in the coming decades. Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. In order to tackle antibiotic resistance, we will implement in our tertiary care university hospital a computerised-decis...
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Objectives: Elevated low-density lipoprotein cholesterol (LDL-C) increases the risk of recurrent cardiovascular disease (CVD) events. We examined use of lipid-lowering therapy (LLT) following ischaemic stroke, and estimated benefits from guideline-based up-titration of LLT. Methods: The Norwegian COgnitive Impairment After STroke (Nor-COAST) stu...
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Objective To assess similarities and differences in the recommended sequence of strategies among the most relevant clinical practice guidelines (CPGs) for the treatment of depression in adults with inadequate response to first-line treatment. Data sources We performed a systematic review of the literature spanning January 2011 to August 2020 in Me...
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Today, reducing oxidative stress and improving the antioxidant system with antioxidant supplements along with exercise training has received a lot of attention. Vitamin D plays a very important role in general health and reducing oxidative stress. The aim of this study was to examine the effect of vitamin D3 supplements during elastic-band resistan...
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PurposeTo externally evaluate the performance of two European risk prediction models, for identifying patients at high-risk of medication harm, in an Australian hospital setting.Methods This was a secondary analysis of a pre-existing cohort study described in a recently published study by Falconer et al. (Br J Clin Pharmacol 87(3):1512–1524, 2021)...
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The European Association for Clinical Pharmacology and Therapeutics (EACPT) is a leading society in Europe serving the European and global Clinical Pharmacology and Therapeutics community. Its specific aims include promotion of the utilisation and divulgation of the utility of clinical pharmacology services in health care delivery. EACPT currently...
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Objective To investigate the prevalence of polypharmacy and characteristics associated with polypharmacy in older adults from seven European cities. Design Cross-sectional study of baseline data from DO-HEALTH. Setting and participants DO-HEALTH enrolled 2157 community-dwelling adults age 70 and older from seven centres in Europe. Participants we...
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Introduction Preliminary data indicates that proactive therapeutic drug monitoring (TDM) is associated with better outcomes compared with empiric dose escalation and/or reactive TDM, and that pharmacokinetic (PK) modelling can improve the precision of individual dosing schedules in Crohn’s disease (CD). However, there are no data regarding the util...
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Purpose To evaluate laboratory and clinical results after unilateral adrenalectomy in patients with primary aldosteronism (PHA). Methods A cross-sectional analysis was performed using data from patients who underwent transperitoneal laparoscopic adrenalectomy for PHA, between January 2008 and December 2019. Surgical indications were based on adren...
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Stearoyl-CoA desaturase (SCD) is a potential therapeutic target for Parkinson’s and related neurodegenerative diseases. SCD inhibition ameliorates neuronal toxicity caused by aberrant α-synuclein, a lipid-binding protein implicated in Parkinson’s disease. Its inhibition depletes monounsaturated fatty acids, which may modulate α-synuclein conformati...
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Objectives Despite a lack of evidence demonstrating superiority to non-steroidal anti-inflammatory drugs, like ketorolac, that are associated with lower risk of harms, opioids remain the most prescribed analgesic for acute abdominal pain. In this pilot trial, we will assess the feasibility of a definitive trial comparing ketorolac with morphine in...
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Macrolide antibiotics have received criticism concerning their use and risk of treatment failure. Nevertheless, they are an important class of antibiotics and are frequently used in clinical practice for treating a variety of infections. This study sought to utilize pharmacoepidemiology methods and pharmacology principles to estimate the risk of ma...