Aim: There is no commercially available urinary cystatin-C (u-CYSC) test in the market. Therefore, we optimized and validated an automated immune turbidimetric test for u-CYSC measurements and investigated u-CYSC concentrations in acute and chronic diseases which might lead to renal tubular disorders. Materials & methods: A particle-enhanced immune turbidimetric assay was adapted and validated on […]
Aim: An LC–MS/MS assay for the quantitation of liraglutide, a peptide-based injectable glucagon-like peptide-1 receptor agonist, has been developed as a convenient alternative to the enzyme-linked immunosorbent assay, and used to characterize liraglutide pharmacokinetics in cynomolgus monkeys. Results: Assay calibration curves exhibited a linear dynamic range of 10–5000 ng/ml and correlation coefficient ≥0.98. Following a
Aim: Although regulatory guidances require human metabolism information of drug candidates early in the development process, the human mass balance study (or hADME study), is performed relatively late. hADME studies typically involve the administration of a 14C-radiolabelled drug where biological samples are measured by conventional scintillation counting analysis. Another approach is the administration of therapeutic
Aim: Lipid mediators (LMs) are broadly defined as a class of bioactive lipophilic molecules that regulate cell-to-cell communication events with many having a strong correlation with various human diseases and conditions. LMs are usually analyzed with LC–MS, but their numerous isomers greatly complicate the measurements with essentially identical fragmentation spectra and LC separations are not
Lipidomics can be defined as the comprehensive quantitative and qualitative analysis of the entire set of lipids present in a given organism. With the recent improvements in analytical technologies and improved coverage of lipidome, there is a resurgence of interest in understanding in detail biological roles of lipids, their regulation and dysregulation which may contribute
Coated blade spray (CBS) is a solid-phase microextraction-based technology that can be directly coupled to MS to enable the rapid qualitative and quantitative analysis of complex matrices. The goal of this mini review is to concisely introduce CBS’s operational fundamentals and to consider how it correlates/contrasts with existing direct-to-MS technologies suitable for bioanalytical applications. In
Aim: An immunomagnetic capture protocol for use with LC–MS was developed for the quantitation of saxitoxin (STX) in human urine. Materials & methods: This method uses monoclonal antibodies coupled to magnetic beads. STX was certified reference material grade from National Research Council, Canada. Analysis was carried out using LC–MS. Results: With an extraction efficiency of
Aim: We proposed a rapid and high quality method to determine α-tocopherol (α-T) in different biopharmaceutical samples using liquid chromatography-diode array detector on-line ESI–MS/MS. Materials & methods: A working standard solution of α-T and internal standard, phenyl-5,7-dimethyl-d6-α-tocopherol, were used for optimization and validation of the method. Levels of α-T in nanoemulsions, serum and plasma samples
Aim: Panitumumab is a monoclonal antibody directed against EGFR that is approved for the treatment of metastatic colorectal cancer. To investigate its pharmacokinetics and concentration–response relationship, a validated assay is required. Results: An ELISA assay was developed and validated according to international recommendations. Six calibrators (ranging from 0.1 to 20 mg/l) plus one anchor point
European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, ‘current analysis of immunogenicity: best practices and regulatory hurdles’, several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving