British Journal of Clinical Pharmacology

No abstract text is available yet for this article.

AIM: To explore international undergraduate pharmacy students' views on integrating artificial intelligence (AI) into pharmacy education and practice. METHODS: This cross-sectional institutional review board-approved multinational, multicentre study comprised an anonymous online survey of 14 multiple-choice items to assess pharmacy students' preferences for AI events in the pharmacy curriculum, the current state of AI education, and students' AI knowledge and attitudes towards using AI in the pharmacy profession, supplemented by eight demographic queries...

AIMS: To characterise the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of oxathridine, a first-in-class histamine-3 receptor partial agonist, in healthy male volunteers. METHODS: A randomised, double-blind, placebo-controlled study including the NeuroCart, consisting of a battery of drug sensitive neurophysiological tests, was performed. Oxathridine was administered orally as an aqueous solution. After dosing, safety and NeuroCart tests (adaptive tracking [AT], body sway [BS], saccadic peak velocity [SPV], smooth pursuit [SP] eye movements, VAS according to Bond and Lader, VAS according to Bowdle [VAS B&L, Bowdle], pharmaco-electroencephalogram [pEEG], Sustained Attention to Response Task [SART]) were performed at set times...

AIMS: This study aimed to provide up-to-date information on pediatric population pharmacokinetics (PopPK) models of tacrolimus and to identify factors influencing tacrolimus pharmacokinetic variability. METHODS: Systematic searches in the Web of Science, PubMed, Scopus, Science Direct, Cochrane, EMBASE databases, and reference lists of articles were conducted from inception to March 2023. All PopPK studies of tacrolimus using nonlinear mixed-effect modeling in pediatric solid organ transplant patients were included...

AIM: A key reason for the failure of anti-tuberculosis (TB) treatment is missed doses (instances where medication is not taken). Adverse drug reactions (ADRs) are one cause of missed doses, but the global evidence, their relative contribution to missed doses versus other causes, the patterns of missed doses due to ADRs, and the specific ADRs associated with missed doses have not been appraised. We sought to address these questions through a scoping review. METHODS: MEDLINE, Embase and Web of Science were searched on 3 November 2021 using terms around active TB, missed doses and treatment challenges...

We analysed the regulatory output of EMA Qualification Procedures on patient-reported outcomes (PROs), observer-reported outcomes (ObsROs) and performance outcomes (PerfOs) finalised between January 2013 and December 2018 to describe the tools, target populations, therapeutic areas, types of questions, endpoint role and the responses of EU regulators. We distilled general learnings from the procedures. Seventeen qualification programs for PROs, 6 for ObsRO tools and 11 for PerfO tools were submitted by consortia, large and small/medium companies...

AIMS: The aim of this umbrella review was to identify tools and guidelines to aid the deprescribing process of potentially inappropriate medications (PIM), evaluate development and validation methods, and describe evidence levels for medication inclusion. METHODS: Searches were conducted on MEDLINE (Ovid), Embase.com, Cochrane CDSR, CINAHL (EBSCO), Web of Science Core Collection, and guideline databases from the date of inception to July 7, 2022 and checked for updated tools on July 17, 2023...

No abstract text is available yet for this article.

Paracetamol (acetaminophen) was marketed in the 1950s as a non-prescription analgesic/antipyretic without any preclinical toxicity studies. It became used increasingly for self-poisoning, particularly in the UK and was belatedly found to cause acute liver damage which could be fatal. Management of poisoned patients was difficult as maximum abnormalities of liver function were delayed for 3 days or more after an overdose. There was no treatment and the mechanism of hepatotoxicity was not known. The paracetamol half-life was prolonged with liver damage occurring when it exceeded 4 hours and the Rumack-Matthew nomogram was an important advance that allowed stratification of patients into separate zones of risk...

Preclinical models have been the backbone of translational research for more than a century. Rats and mice are critical models in the preliminary stages of drug testing, both for determining efficacy and ruling out potential human-relevant toxicities. Historically, most preclinical pharmacological studies have used young, relatively healthy, inbred male models in highly-controlled environments. In the field of geriatric pharmacology, there is a growing focus on the importance of using more appropriate preclinical models both in the testing of therapeutics commonly used in older populations, and in the evaluation of potential geroprotective drug candidates...

Cefiderocol is a broad spectrum cephalosporin antibiotic and is indicated in patients with difficult-to-treat Gram-negative bacterial infections. Cefiderocol is applied as a 2 to 4 times daily prolonged 3-hour infusion. The therapeutic target of cefiderocol suggests that continuous infusion (CI) may be advantageous, since it is more likely to achieve 100% of time of the unbound concentration above the minimal inhibitory concentration (fT>MIC). Yet, limited information on cefiderocol as CI has been assessed...

AIM: This paper aims to explore the possibility of employing large language models (LLMs) - a type of artificial intelligence (AI) - in clinical pharmacology, with a focus on its possible misuse in bioweapon development. Additionally, ethical considerations, legislation, and potential risk reduction measures are analysed. METHODS: A comprehensive review of existing literature investigates the potential misuse of AI and LLMs in bioweapon creation. The search includes articles from PubMed, Scopus, and Web of Science Core Collection that were identified using a specific protocol...

AIM: The objective of the study was to describe the impact of a clinical decision support system (CDSS) on antidiabetic drug management by clinical pharmacists for hospitalized patients with T2DM. METHODS: We performed a retrospective, single-center study in a teaching hospital, where clinical pharmacists analyzed prescriptions and issued pharmacist interventions (PIs) through a computerized physician order entry (CPOE) system. A CDSS was integrated into the pharmacists' workflow in July 2019...

Novel Gonadotrophin Releasing Hormone (GnRH) antagonist treatments have recently been developed in combination with hormonal add-back therapy, as an oral treatment option for women suffering from uterine fibroids. Registration trials assessing the GnRH antagonist combination preparations with relugolix, elagolix, and linzagolix have assessed treatment efficacy for fibroid related heavy menstrual blood loss in comparison to placebo. Marketing authorization has been granted by several agencies including those in Europe, the United Kingdom, and the United States...

No abstract text is available yet for this article.

Chemodenervation with botulinum neurotoxin type A (BoNTA) is the preferred method for focal spasticity management among various treatment options. While BoNTA injection is considered safe, its widespread use and increasing evidence raise safety concerns. In this paper, we present a patient with central pontine myelinolysis, a rare disease, who developed Acute Respiratory Distress Syndrome (ARDS) on the third day after BoNTA application to the spastic gastrocnemius muscle group and required intubation in the intensive care unit due to this complication...

AIM: To evaluate the performance of chat generative pre-trained transformer (ChatGPT) in key domains of clinical pharmacy practice, including prescription review, patient medication education, adverse drug reaction (ADR) recognition, ADR causality assessment, and drug counseling. METHODS: Questions and clinical pharmacist' answers were collected from real clinical cases and clinical pharmacist competency assessment. ChatGPT's responses were generated by inputting the same question into the "New Chat" box of "ChatGPT Mar 23 Version"...

The potential of using ChatGPT in pharmacometrics was explored in this study, with a focus on developing a population pharmacokinetic (PK) model for standard half-life factor VIII. Our results demonstrated that ChatGPT can be utilized to accurately obtain typical PK parameters from literature, generate a population PK model in R, and develop an interactive Shiny application to visualize the results. ChatGPT's language generation capabilities enabled the development of R codes with minimal programming knowledge and helped to identify as well fix errors in the code...

AIM: This phase I study investigated potential drug-drug interactions of the maturation inhibitor GSK3640254 (GSK'254) with darunavir/ritonavir (DRV/RTV) and/or etravirine (ETR). METHODS: In this randomized, open-label, single-sequence, multiple-dose study, healthy participants received GSK'254 200 mg once daily alone or co-administered with DRV/RTV 600/100 mg twice daily (BID; n=19), ETR 200 mg BID (n=19), or DRV/RTV 600/100 mg + ETR 200 mg BID (n=16) under fed conditions...

AIM: Azathioprine (AZA) and 6-mercaptopurine (6MP) are prescribed in acute lymphoblastic leukemia (ALL) and inflammatory bowel diseases (IBD). Metabolism to active 6-thioguanine (6TGN) and 6-methylmercaptopurine nucleotides (6MMPN) is variable but therapeutic drug monitoring (TDM) remains debatable. This study reports on factors impacting on red blood cell (RBC) metabolites concentrations in children to facilitate TDM interpretation. METHODS: The first paediatric TDM samples received during year 2021 were analyzed, whatever indication and thiopurine drug...