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Background: IQ-1 is a promising c-Jun-N-terminal kinase inhibitor and nitrovasodilator. An LC–MS/MS method was validated to determine IQ-1 isomers and major metabolite IQ-18 in rat plasma. Materials & methods: The analytes were extracted using ethyl acetate. The chromatographic separation was performed on a C8 column (150 × 4.6 mm, 5 μm) under acetonitrile–water (5 mM […]

Background: Although cell-mediated cytotoxicity has been evaluated with various protocols, methods for monitoring cytotoxicity in a time series have not been established. This work describes a method for evaluating cytotoxicity using a multi-chamber real-time luminometer. Materials & methods: The efficiency of effector CD8+ T-cell expansion from melanoma-bearing splenocytes was analyzed. The effect of CD8+ T

In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory expectations in the guideline, as identified in feedback from the

Bioinformatics plays a critical role in the advancement of peptidomics by providing powerful tools for data analysis, interpretation and integration. Peptidomics is concerned with the study of peptides, short chains of amino acids with diverse biological functions. This area includes peptide identification and characterization, database construction, de novo sequencing, functional annotation, omics data integration and

Aim: This paper describes a case study of an antibody therapeutic targeting a membrane-bound receptor, also present in systemic circulation, as a soluble receptor. During phase I studies of astegolimab, nonlinear pharmacokinetics (PKs) were observed. We investigated the potential contribution of antidrug antibodies, target-mediated drug disposition and assay format. Materials & methods: A more target-tolerant

Background: Alternatives to phlebotomy in clinical trials increase options for patients and clinicians by simplifying and increasing accessibility to clinical trials. The authors investigated the technical and logistical considerations of one technology compared with phlebotomy. Methodology: Paired samples were collected from 16 donors via a second-generation serum gel microsampling device and conventional phlebotomy. Microsamples were

Aim: To investigate the impact of sample replication number (duplicate vs triplicate) on the validation of ELISA methodology. Materials & methods: The methodology was validated with reference sample and test sample as an 11-point triplicate dilution series. The data were reanalyzed post-validation as if conducted as a duplicate dilution series. Results: The triplicate methodology was

The 14th Japan Bioanalysis Forum Symposium was held at Tower Hall Funabori, Japan from 1–3 March 2023. The conference theme, ‘Bringing Together – the Expertise of Bioanalysis’, aimed to enable people from various fields to gather, learn and collaborate together for the common goal of delivering medicines to patients faster. Approximately 360 participants from various

Aims: This work was designed to provide early diagnosis strategies for Alzheimer’s disease (AD) based on the identification of blood metabolic biomarkers. Patients & methods: A total of 90 subjects aged 60 years or older were included in this study; 45 patients were assigned to the case group and control group, respectively. A total of

Background: Erythropoietin receptor agonists (ERAs) are substances prohibited in sports and currently monitored in urine and blood. There is a great interest in new matrices like dried blood spots (DBSs). Method: A direct method for the detection of ERAs in DBSs using one single spot of 25 μl has been optimized and validated. Results: Limits