Background: The small blood volume of mice complicates tacrolimus pharmacokinetic studies in these animals. Here we explored dried blood spot (DBS) as a novel method to measure tacrolimus blood concentrations in mice. DBS samples were collected from three sampling sites (cheek, tail and heart) and compared with heart whole blood samples measured via LC–MS/MS. Results: […]
Aim: To develop a bioanalytical method for quantifying INCB000928 in human saliva. Materials & methods: Human centrifuged saliva and human whole saliva were compared for matrix selection. Protein precipitation extraction and HPLC–MS/MS was used for analysis. Results & conclusion: Nonspecific binding of INCB000928 was reduced in whole versus centrifuged saliva. Whole saliva was a preferred matrix for INCB000928 bioanalytical method validation. Incurred sample reanalysis (ISR) using a successfully validated method failed in a healthy volunteer study because of inhomogeneous INCB000928 concentration across sample tube
In the Research Article by Sakambari Tripathy, Daria Wentzel, Xia (Katty) Wan & Olga Kavetska, titled ‘Validation of enantioseparation and quantitation of an active metabolite of abrocitinib in human plasma’ and published in the October 2021 issue of Bioanalysis (Bioanalysis 13[19], 1477–1486; DOI: 10.4155/bio-2021-0128), the following errors were brought to our attention: The editors of Bioanalysis would like to apologise
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Background: Inhibition of the enzyme dipeptidyl peptidase 4 (DPP-4) is a pharmaceutical treatment for type 2 diabetes. To demonstrate bioequivalence of enzyme inhibition of a new dosage form of the inhibitor vildagliptin, a method for enzyme activity was developed, validated and applied using liquid chromatography and tandem mass spectrometry (LC-MS/MS). Results: The method was validated
Aim: To report the development and validation of an LC-MS/MS method for the simultaneous determination of unconjugated payload DM4 and its metabolite S-methyl-DM4 in human plasma. Methodology: A workflow of protein precipitation followed by reduction and solid phase extraction was employed to remove antibody–maytansinoid conjugates from plasma matrix, release DM4 from endogenous conjugates, and generate
Background: The capability of targeted MS-based methods to simultaneously measure multiple analytes with high selectivity and sensitivity greatly facilitates the discovery and quantitation of novel biomarkers. However, the complexity of biological samples is a major bottleneck that requires extensive sample preparation. Results: This paper reports a generic workflow to optimize surrogate peptide-based protein biomarker screening
Background: With the spread of COVID-19, anti-SARS-CoV-2 antibody tests have been utilized. Herein we evaluated the analytical performance of anti-SARS-CoV-2 antibody test kits using a new reference standard prepared from COVID-19 patient sera. Methods: Fifty-seven kits in total (16 immunochromatography types, 11 ELISA types and 30 types for automated analyzers) were examined. By measuring serially
The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued ‘Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents’ as the guidance of registration of antigen and antibody test reagents
Background: Sphingolipidoses are caused by a defective sphingolipid catabolism, leading to an accumulation of several glycolipid species in tissues and resulting in neurotoxicity and severe systemic manifestations. Methods & results: Urine samples from controls and patients were purified by solid-phase extraction prior to the analysis by ultra-high-performance liquid chromatography (UPLC) combined with MS/MS. A UPLC–MS/MS