Clinical Pharmacology - Science topic

This study evaluated initial antihypertensive drug prescription patterns in Indian healthcare settings. An observational, cross‐sectional, prospective prescription registry analyzed prescriptions for 4723 newly diagnosed hypertension patients. Additionally, it investigated the extent to which physicians adhered to either European or Indian hyperten...

To assess the clinical usefulness of teicoplanin optimized by means of a therapeutic drug monitoring (TDM)-guided approach for treating secondary bloodstream infections (BSIs) caused by Enterococcus faecium. Hospitalized patients having in the period 1 March 2021–31 October 2024 a documented BSI caused by glycopeptide-susceptible Enterococcus faeci...

Background Minimizing the duration of mechanical ventilation is one of the most important therapeutic goals during the care of preterm infants at neonatal intensive care units (NICUs). The rate of extubation failure among preterm infants is between 16% and 40% worldwide. Numerous studies have been conducted on the assessment of extubation suitabili...

Phosphodiesterase-4 (PDE4) is involved in the synthesis of inflammatory cytokines that mediate several chronic inflammatory disorders, including psoriasis and atopic dermatitis. In recent years, the therapeutic armamentarium in dermatology has expanded with the introduction of PDE4 inhibitors, both in oral and topical formulations. PDE4 inhibitors...

One of the goals of clinical pharmacology is to optimize patient treatment by adopting new treatment strategies which will increase the efficacy of the treatment and decrease the adverse effects of the drugs. In the literature, it has shown that the effectiveness and toxicity of medications can vary significantly based on when they are administered...

Hepatic impairment (HI) trials are traditionally part of the clinical pharmacology development to assess the need for dose adaptation in people with impaired metabolic capacity due to their diseased liver. This review aimed at looking into the data from dedicated HI studies, cluster these data into various categories and connect the effect by HI wi...

Background Selecting the optimal dose for clinical development is especially problematic for drugs directed at CNS‐specific targets. For drugs with a novel mechanism of action, these problems are often greater. We describe Xanamem’s clinical pharmacology, including the approach to dose selection and proof‐of‐concept studies. Xanamem is an isoform 1...

Lecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to protofibrils of amyloid‐beta (Aβ) protein. In 18‐month clinical studies, lecanemab has been shown to reduce a complex group of protein interactions associated with early symptomatic Alzheimer’s disease (AD) and slow decline on clinical endpoints of cognition and functio...

Introduction: The demand for basic culturally competent care has increased with the internationalization and diversification of the world. However, this research focuses on analyzing how effective the transcultural curriculum is in Karachi, Pakistan. This study aimed to assess the effectiveness of a modified transcultural training program on the cu...

Dental pain is common, and many patients use analgesics to alleviate the pain. Analgesics are readily accessible, and overdosing may lead to severe complications. This study explores the extent of analgesic overdosing in patients with dental pain. Data were collected from two dental emergency clinics in Copenhagen, Denmark, via questionnaires and i...

Thiamine and ascorbic acid have been increasingly studied for their potential benefits in treating septic patients in intensive care units (ICUs). This review brings together recent findings from databases such as PubMed, Scopus, Web of Science, and Google Scholar, focusing on studies published in the last ten years. These vitamins play critical ro...

Mathematical models of thrombin generation (TG) that have been developed are based on a systems biology approach. Although this approach provides important information about the coagulation system, its clinical applicability is limited by its complexity and number of input variables required. The aim of this study was to develop a semimechanistic m...

Objective The objective of this study was to investigate the preparation process of Mahuang Xixin Fuzi decoction granules based on the clinical pharmacological effects of the classic formulas and to control the quality of the product. Methods An orthogonal experimental design was used, with extraction yield and transfer rate of key ingredients as e...

Background Diabetes often causes diabetic nephropathy (DN), a serious long-term complication. It is characterized by chronic proteinuria, hypertension, and kidney function decline, can progress to end-stage renal disease, lowering patients’ quality of life and lifespan. Inflammation and apoptosis are key to DN development. Network pharmacology, cli...

Intravenous (IV) vasopressors are essential in the management of hypotension and shock. Initiation of oral vasoactive agents to facilitate weaning of IV vasopressors to liberate patients from the intensive care unit is common despite conflicting evidence regarding the benefits of this practice. While midodrine appears to be the most frequently stud...

O manejo anestésico desempenha um papel crucial no controle do sangramento durante cirurgias ortopédicas, influenciando fatores como agregação plaquetária, cascatas de coagulação e estabilidade hemodinâmica. Diferentes técnicas anestésicas, como bloqueios regionais e anestesia geral, apresentam impactos variados nos mecanismos hemostáticos, sendo e...

The Bipolar-Schizophrenia Network for Intermediate Phenotypes (B-SNIP) created psychosis Biotypes based on neurobiological measurements in a multi-ancestry sample. These Biotypes cut across DSM diagnoses of schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis. Two recently developed post hoc ancestry adjustment methods of Po...

The FDA has released new draft guidance to standardize how immunogenicity of protein therapeutics is described in product labels. A key aspect to this new guidance is that companies should describe anti-drug antibodies that have clinical significance in addition to reporting ADAs’ incidence. Factors to consider when determining clinical significanc...

This report summarizes the proceedings for Day 3 of the workshop titled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”. This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the...

This study aims to investigate the alteration in biochemical and heamatological parameters in Covid-19 patients. Total 200 patients were randomly selected during their hospitalization in Holy family Hospital Rawalpindi, Pakistan. The patients were then categorized as severe and non-severe group as per criteria provided by WHO and nasal swabs for qP...

Background: Tacrolimus is characterized by a high intra and interindividual pharmacokinetics variability. Data regarding factors that may influence its pharmacokinetics and pharmacodynamics in liver transplantation are limited. The objectives of this study were to assess tacrolimus therapeutic response, pharmacokinetics and adherence in liver trans...

Introduction Insulin icodec is a basal insulin designed for once‐weekly administration. This study assessed the pharmacological properties of icodec in Japanese individuals with type 1 diabetes (T1D). Materials and Methods In a randomized, open‐label, crossover study, 24 Japanese individuals with T1D (20–64 years; glycated hemoglobin ≤9.0%) receiv...

Introduction: For centuries, teaching and learning have been an integral part of human existence, and will continue to be so. However, the field has undergone significant transformations in recent decades, with the introduction of e-learning being the latest development. Several factors have driven the growth of e-learning, including shifting stude...

The Bipolar-Schizophrenia Network for Intermediate Phenotypes (B-SNIP) created psychosis Biotypes based on neurobiological measurements in a multi-ancestry sample. These Biotypes cut across DSM diagnoses of schizophrenia, schizoaffective disorder and bipolar disorder with psychosis. Two recently developed post hoc ancestry adjustment methods of Pol...

Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV‐1. People living with HIV‐1 receiving methadone maintenance therapy may benefit from islatravir. This study was designed to evaluate single‐dose islatravir on steady‐state methadone pharmacokinetics. A nonrandomized, open‐label study (NC...

Artificial intelligence has had a profound impact on life sciences. This review discusses the application, challenges, and future development directions of artificial intelligence in various branches of life sciences, including zoology, plant science, microbiology, biochemistry, molecular biology, cell biology, developmental biology, genetics, neur...

Drug Information Centres (DICs) are providing clinicians with evidence-based support for rational drug treatment. However, knowledge gaps in the literature may hinder DICs from offering optimal guidance. This study examined the extent and nature of these knowledge gaps and their impact on clinical pharmacological advice, using real-world query data...

What is this summary about? This is a plain language summary of an article published in the journal Clinical Pharmacology in Drug Development. It is about a study of a medicine called vibegron. Vibegron is approved by the US Food and Drug Administration (also called the FDA) to treat overactive bladder, also known as OAB. It may be easier for peopl...

Objective Oral antitumour therapeutics (OAT) are increasingly used due to improvements in outcomes and their convenient application. However, complex intake regimens pose several challenges. The randomised AMBORA trial (Medication Safety With Oral Antitumour Drugs) demonstrated highly positive outcomes of a clinical pharmacological/pharmaceutical c...

Introduction The administration of drugs is an important part of nurses’ professional practice. A basic knowledge of pharmacological principles is required to make accurate decisions about drug management and conduct patient medication education. However, several studies have suggested that nurses have inadequate knowledge of pharmacology and medic...

Aims A 42‐year‐old male developed chronic primary hypoparathyroidism after total thyroidectomy. Conventional therapy led to recurrent nephrolithiasis and therefore rhPTH(1‐84) (parathyroid hormone [PTH]) treatment was considered. According to the dosing guideline for PTH, calcium plasma levels are adequately controlled with once‐daily administratio...

Aims This study evaluates how changes in intestinal bile acid composition, induced by cholestyramine, a bile acid sequestrant, affect metformin's pharmacodynamics (PD). Methods An open‐label, 2‐period 1‐sequence crossover study was conducted with healthy male adults. Each period consisted of both before and after metformin treatments. Cholestyrami...

Mass spectrometry (MS) is the only instrumental analytical technology that utilizes unique properties of matter, that is, its mass (m) and electrical charge (z). In the magnetic and/or electric fields of mass spectrometers, electrically charged native or chemically modified (millions) endogenous and (thousands) exogenous substances, the analytes, a...

Antimicrobial resistance (AMR) is a serious threat to global public health. It increases morbidity and mortality, and is associated with high economic costs due to its health care burden. Medical students are particularly important since they will be the future leaders in clinic practice, responsible for antibiotic prescription and communication ab...

Background Despite efforts to improve undergraduate clinical pharmacology & therapeutics (CPT) education, prescribing errors are still made regularly. To improve CPT education and daily prescribing, it is crucial to understand how therapeutic reasoning works. Therefore, the aim of this study was to gain insight into the therapeutic reasoning proces...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has published an addendum on estimands and sensitivity analysis in clinical trials along with related training materials. These define an estimand as a precise description of the treatment effect that reflects the scientific question of interest....

My name is Mehrasa Nikandish , my work focus on clinical pharmacology, and the safety of the medications regarding to the comparison between z drugs and benzodiazepines.

Aim Brensocatib is an oral, selective, competitive and reversible dipeptidyl peptidase 1 inhibitor in development for the treatment of bronchiectasis. This study evaluated the pharmacokinetics (PKs), safety and tolerability of brensocatib in participants with varying degrees of renal impairment and normal renal function. Methods In this phase 1, m...

Background Placebo and nocebo effects are widely reported across psychiatric conditions, yet have seldom been examined in the context of gambling disorder. Through meta-analysis, we examined placebo effects, their moderating factors, and nocebo effects, from available randomised, controlled pharmacological clinical trials in gambling disorder. Met...

Introduction Alcohol withdrawal is typically managed using benzodiazepines. However, modulation of both γ-aminobutyric acid-A and N-methyl-d-aspartate-receptors through ethanol provision may provide an alternative management strategy. This systematic review critically analyses the evidence surrounding the use of oral or intravenous ethanol for the...

The increase in the availability of real‐world data (RWD), in combination with advances in machine learning (ML) methods, provides a unique opportunity for the integration of the two to explore complex clinical pharmacology questions. Here we present a recently developed RWD/ML framework that utilizes ML algorithms to understand the influence and i...

Antimicrobial resistance has become one of the rapidly evolving public health crises worldwide, and this has been partly attributed to irrational prescribing and use of antimicrobial agents. Noting this threat, in 2015, the World Health Organization (WHO) developed a global action plan (GAP) for mitigating the problem. The GAP included optimisation...

Aims Dostarlimab‐gxly is a humanized monoclonal antibody of the IgG4 isotype that binds to the programmed cell death protein‐1 (PD‐1) receptor and blocks its ligands. RUBY (NCT03981796) is a two‐part multicentre study in patients with recurrent or primary advanced endometrial cancer. The overall aims were to characterise the population pharmacokine...

Background/aims Due to a lack of standard pediatric prescribing information, medicines are often used in a dosage form or for an indication that has not been investigated in children. Pediatric clinical trial research networks aim to facilitate the timely availability of innovative drugs for children by developing standardized trial facilitation an...

Background The purpose of the present study was to evaluate the use of a free online continuing education (CE) course that sought to address barriers of capability by training dental team members in the specific recommendations of the American Dental Association (ADA)-endorsed adult guideline for the pharmacologic management of acute dental pain, s...

Qingdai (QD), derived from various plant sources, is commonly used in traditional Chinese medicine for ulcerative colitis (UC) treatment. However, the clinical efficacy and mechanisms of orally administered QD remain unclear. This study aims to evaluate QD’s efficacy in UC treatment and uncover its active components and mechanisms. A randomized con...

Background ADCs combined with immunotherapy represent a promising anti-cancer approach. However, such combinations often result in increased toxicity. Subcutaneous (SC) delivery offers a safer alternative, with comparable efficacy to intravenous delivery, as demonstrated by treatments like amivantamab. JSKN033 is a FDC for SC injection, utilizing i...

Background TAK-102 is an investigational GPC3 targeted CAR-T therapy armoured with IL-7 and CCL19 to enhance proliferation/persistence and induce host-immune cell infiltration respectively. An open-label, non-randomized phase-1 study (NCT04405778) was conducted in patients with GPC3+ solid tumors to evaluate safety and tolerability of TAK-102 as we...

Background In Phase 3 study CheckMate 67T (NCT04810078), SC nivolumab demonstrated noninferiority of time-averaged serum concentration over 28 days (Cavgd28) and minimum serum concentration at steady state (Cminss), the study’s co-primary endpoints, vs. intravenous (IV) nivolumab in patients with advanced or metastatic clear cell renal cell carcino...

RLYB212 is a human monoclonal anti‐human platelet antigen (HPA)‐1a immunoglobulin gamma 1 in clinical development as a subcutaneous injection for the prevention of maternal alloimmunization to fetal HPA‐1a leading to fetal and neonatal alloimmune thrombocytopenia (FNAIT). This analysis developed a target‐mediated drug disposition (TMDD) model to si...

Background Ensuring patient safety is of paramount importance in healthcare systems. Rising concerns about medical errors in the UK have necessitated a greater focus on studying the nature of such errors, particularly those involving high-risk medications. Objectives To conduct a retrospective analysis of incidents related to patient safety in the...

Catecholamines and its metabolites play significant physiological roles in the human body. Paraganglioma and pheochromocytoma are rare tumors of an adrenal region that affect the catecholamines and their metabolites (metanephrine (MN) and normetanephrine (NMN)) concentration. Given the significance of these metabolites for diagnosing, managing, and...

Asciminib is a first-in-class allosteric inhibitor of the kinase activity of BCR::ABL1, specifically targeting the ABL myristoyl pocket (STAMP). This review focuses on the pharmacokinetic (PK) and pharmacodynamic data of asciminib, which is approved at a total daily dose of 80 mg for the treatment of adult patients with chronic myeloid leukemia in...

The article discusses the treatment of chronic form of viral hepatitis C (HVGS) in children. Many problems of the issue under consideration relate to both the scarcity of official statistics and the ambiguity of approaches to the treatment of HVGS in children in our country and abroad. The authors show the most problematic loci from various aspects...

Bempedoic acid is a new drug that improves the control of cholesterol levels, either as monotherapy or in combination with existing lipid-lowering therapies, and shows clinical efficacy in cardiovascular disease patients. Thus, patients with comorbidities and under multiple therapies may be eligible for bempedoic acid, thus facing the potential pro...

With the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guidelines in effect from 2018, the design of Asia‐inclusive multiregional clinical trials (MRCTs) has been streamlined, thereby enabling efficient simultaneous global development. Furthermore, with the recent regulatory reforms...

Maternal medication use may expose the developing fetus through placental transfer or the infant through lactational transfer. Because pregnant and lactating individuals have been historically excluded from early drug development trials, there is often limited to no human data available to inform pharmacokinetics (PK) and safety in these population...

Sea buckthorn (Hippophae rhamnoides L.) contains a variety of biologically active compounds, including flavonoids, terpenoids, polysaccharides, organic acids, volatile oils, and vitamins. It has been demonstrated to be effective in the treatment of cardiovascular disorders. In this paper, we evaluated the pharmacological effects of sea buckthorn in...

Objective Zanubrutinib is a second-generation Bruton’s tyrosine kinase inhibitor that has been approved for the treatment of several B cell malignancies. The aim of this study was to evaluate adverse events (AEs) associated with zanubrutinib based on the real-world data. Design A disproportionality analysis was performed to identify the potential...

A farmacoepidemiologia visa compreender o perfil de utilização de medicamentos por uma dada população e avaliar a segurança e eficácia dos medicamentos utilizados, com forte correlação com a farmacologia clínica. O presente estudo teve como objetivo a definição do perfil farmacoepidemiológico do Centro de Saúde de Guarus e sua interação com os comp...