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Development and validation of an LC–MS/MS method to quantify kynurenic acid in human plasma
Development and validation of an LC–MS/MS method to quantify kynurenic acid in human plasma
Background: Monitoring levels of endogenous biomarkers has become an alternative approach to assess transporter-mediated d...
Validation of an LC–MS/MS method for the determination of sotorasib, a KRASG12C inhibitor, in human plasma
Validation of an LC–MS/MS method for the determination of sotorasib, a KRASG12C inhibitor, in human plasma
Background: Sotorasib (AMG 510) is a first-in-class KRASG12C inhibitor that received accelerated US FDA approval in 2021 f...
Evaluation of hemaPEN® sampling device for measurement of cocaine and metabolites in capillary blood by LC-MS/MS
Evaluation of hemaPEN® sampling device for measurement of cocaine and metabolites in capillary blood by LC-MS/MS
Background: Dried blood spot sampling has been reported for on-site collection of specimens, but measurements are affected...
Bioanalysis of INCB000928 in hemodialysate: prevention of nonspecific binding and validation of surrogate matrices
Bioanalysis of INCB000928 in hemodialysate: prevention of nonspecific binding and validation of surrogate matrices
Aim: To develop and validate a bioanalytical method for the quantification of INCB000928 in hemodialysate. Materials &...
Development and multicenter validation of an LC–MS-based bioanalytical method for antisense therapeutics
Development and multicenter validation of an LC–MS-based bioanalytical method for antisense therapeutics
Background: Many bioanalytical methods for antisense oligonucleotides (ASOs) using LC–MS have been reported. However, no d...
An insight into the presence of impurities in reference standards and their impact on mass spectrometry-based bioanalysis
An insight into the presence of impurities in reference standards and their impact on mass spectrometry-based bioanalysis
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial intere...
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum
Background: HMBD-001 is an IgG1 humanized monoclonal antibody specifically targeting HER3, a receptor highly expressed on ...
Development of a selective, sensitive and robust oxyntomodulin dual monoclonal antibody immunoassay
Development of a selective, sensitive and robust oxyntomodulin dual monoclonal antibody immunoassay
Background & Aim: Oxyntomodulin (Oxm) is a proglucagon-derived peptide agonist of both the GLP-1 and glucagon receptor...
Development and validation of methods that enable high-quality droplet digital PCR and hematological profiling data from microvolume blood samples
Development and validation of methods that enable high-quality droplet digital PCR and hematological profiling data from microvolume blood samples
Aim: Mouse models have been crucial to preclinical studies in the increasingly relevant fields of cell and gene therapy. H...
Prediction of frozen virus stability based on degradation mechanisms, real-time data and modeling
Prediction of frozen virus stability based on degradation mechanisms, real-time data and modeling
Aim: Critical virus reagents in regulated bioanalytical assays require stability monitoring. Although stability at ultralo...
Feasibility of using PALSAR technology as a signal amplifier for antibody bridging assay
Feasibility of using PALSAR technology as a signal amplifier for antibody bridging assay
The immunogenicity testing of oligonucleotide drugs using an antibody bridging assay has been scarcely investigated. We de...
An ultra-performance LC–MS/MS method for determination of JRF103 in human plasma: application in first-in-patient study
An ultra-performance LC–MS/MS method for determination of JRF103 in human plasma: application in first-in-patient study
Background: JRF103, a novel pan-HER inhibitor, has shown potent activity against HER1, HER2, HER4 and EGFR in vitro. To su...
Application of a new volumetric microsampling device for quantitative bioanalysis of immunosuppression
Application of a new volumetric microsampling device for quantitative bioanalysis of immunosuppression
Background: Volumetric absorptive microsampling may reduce the blood collection burden associated with therapeutic drug mo...
Efficient interactions with bioanalytical contract research organizations: inside scoop
Efficient interactions with bioanalytical contract research organizations: inside scoop
The authors are employed in a contract research organization. The authors have no other relevant affiliations or financial...
Development and validation of an LC-MS/MS method for the quantification of fascin proteins in human serum
Development and validation of an LC-MS/MS method for the quantification of fascin proteins in human serum
Background: Fascin is an actin-bundling protein that has been linked to tumor cell migration, invasion, metastasis, diseas...
A whole blood microsampling furosemide assay: development, validation and use in a pediatric pharmacokinetic study
A whole blood microsampling furosemide assay: development, validation and use in a pediatric pharmacokinetic study
Background: Furosemide is a commonly used diuretic for the treatment of edema. The pharmacokinetics of furosemide in neona...
Accelerator mass spectrometry for quantification of micro- and therapeutic dose diclofenac in microdialysis samples
Accelerator mass spectrometry for quantification of micro- and therapeutic dose diclofenac in microdialysis samples
Background: Microdialysis sampling after drug microdosing may provide tissue pharmacokinetic data early in clinical drug d...
Bioanalysis by LC-MS/MS and preclinical pharmacokinetic interaction study of ribociclib and oleanolic acid
Bioanalysis by LC-MS/MS and preclinical pharmacokinetic interaction study of ribociclib and oleanolic acid
Background: Ribociclib (RIBO), approved in 2017 for HR-positive and HER-2-negative metastatic breast cancer treatment is r...
Thalidomide measurement in plasma and dried plasma spot by SPE combined with UHPLC-MS/MS for therapeutic drug monitoring
Thalidomide measurement in plasma and dried plasma spot by SPE combined with UHPLC-MS/MS for therapeutic drug monitoring
Aims: To validate an SPE-ultra-HPLC-MS/MS method for thalidomide (THD) measurement in dried plasma spot (DPS). Methods: Ex...
Research progress of N-nitrosamine detection methods: a review
Research progress of N-nitrosamine detection methods: a review
N-Nitrosamines (nitrosamines) are attracting increased attention because of their high toxicity and wide distribution. The...
Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective
Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial intere...
Greener bioanalytical sample preparation. What is next?
Greener bioanalytical sample preparation. What is next?
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest...
Development and implementation of urinary transporter biomarkers to facilitate assessment of drug–drug interaction
Development and implementation of urinary transporter biomarkers to facilitate assessment of drug–drug interaction
Aim: Novel urinary biomarker evaluation approaches to support inhibition assessment for renal transporters (e.g., OCT2, mu...
Method development workflow for quantifying protein biomarkers by hybrid LC–MS/MS
Method development workflow for quantifying protein biomarkers by hybrid LC–MS/MS
Background: Industry-standard guidance on method development and validation of hybrid LC–MS/MS assays for protein biomarke...
Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies
Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies
Aim: Assessment of pre-existing anti-drug antibody (preADA) reactivity at early drug development stages can be beneficial ...
HPLC method for simultaneous estimation of paclitaxel and baicalein: pharmaceutical and pharmacokinetic applications
HPLC method for simultaneous estimation of paclitaxel and baicalein: pharmaceutical and pharmacokinetic applications
Aim: A novel HPLC method was developed and validated for the simultaneous estimation of paclitaxel (PTX) and baicalein (BA...
Surrogate peptide selection and internal standardization for accurate quantification of endogenous proteins
Surrogate peptide selection and internal standardization for accurate quantification of endogenous proteins
Relative quantification techniques have dominated the field of proteomics. However, biomarker discovery, mathematical mode...