Background: Hyperlipidemia is one of the most common chronic diseases encountered globally, and atorvastatin (ATV) is mainly metabolized into two major active metabolites. Methodology: Hence, we aimed to estimate ATV and ezetimibe (EZE) simultaneously in the presence of ATV major and active metabolites using a validated LC–MS/MS method. Conclusion: The proposed method was linear (r2 […]
In new drug development, cells or animals are treated with the selected candidate compound to confirm its efficacy and safety in nonclinical studies. Clinical laboratory tests are carried out using samples from experimental animals in these studies. The clinical laboratory test method validation in nonclinical fields should be conducted keeping in mind that the circumstances
Background: Monitoring levels of endogenous biomarkers has become an alternative approach to assess transporter-mediated drug–drug interactions in clinical trials. Among the biomarkers of interest, kynurenic acid is effective for the human organic anion transporters OAT1 and OAT3. Here, a simple and robust bioanalytical method was developed using LC–MS/MS to quantify kynurenic acid in human plasma.
Background: The instability of aldehydes in biological matrices is associated with their reactions with thiol and amino moieties in proteins. This chemical reaction is reversible by nature and highly pH dependent. Method: A novel approach that includes protein precipitation with an acidic solution of acetonitrile/water/formic acid (85/14/1; v/v/v) was developed to efficiently recover Aldehyde-1 from
Aim: A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Materials & methods: Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by
Background: Dried blood spot sampling has been reported for on-site collection of specimens, but measurements are affected by blood hematocrit, and special handling is required, especially for forensic applications. The hemaPEN® blood collection device was developed to produce spots with constant volume. Results: Linearity between 1 and 500 ng/ml was shown for cocaine and the
Background: Sotorasib (AMG 510) is a first-in-class KRASG12C inhibitor that received accelerated US FDA approval in 2021 for the treatment of patients with KRASG12C-mutated locally advanced or metastatic non-small-cell lung cancer. Method: An LC–MS/MS method was developed and validated for the determination of sotorasib in human plasma to support clinical development studies. Samples were prepared
Aim:IDH mutations have been identified as frequent molecular lesions in several tumor types, particularly in gliomas. As a putative marker of IDH mutations, elevated D-2-HG has been reported in glioma, acute myeloid leukemia and intrahepatic cholangiocarcinoma. Excessive production of L-2-HG has also been described in renal cell carcinoma and 2-hydroxyaciduria. Materials & methods: The authors
Aim: To develop and validate a bioanalytical method for the quantification of INCB000928 in hemodialysate. Materials & methods: Blank dialysate and phosphate-buffered saline were compared with hemodialysate for surrogate matrix selection. Direct addition of internal standard without analyte extraction and a high-performance LC–MS/MS were used for analysis. Results & conclusion: INCB000928 in hemodialysate exhibited strong
Approximately 280 people from pharmaceutical industries, contractors, academic institutions and regulatory authorities attended the 13th Japan Bioanalysis Forum Symposium. The symposium was held via web to prevent the spread of COVID-19 from the 28 February to 2 March 2022. The theme of the symposium was ‘All for One Goal’, and the event has provided an