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Interlaboratory evaluation of LC–MS-based biomarker assays
Interlaboratory evaluation of LC–MS-based biomarker assays
Validation of biomarker assays is crucial for effective drug development and clinical applications. Interlaboratory reprod...
Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics
Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics
The measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because the formation and incid...
A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood
A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood
Background: Blood-invasive fungal infections can cause the death of patients, while diagnosis of fungal infections is chal...
Immunocapture LC–MS methods for pharmacokinetics of large molecule drugs
Immunocapture LC–MS methods for pharmacokinetics of large molecule drugs
Implementation of immunocapture LC–MS methods to characterize the pharmacokinetic profile of large molecule drugs has beco...
Highlights from the 25th International Reid Bioanalytical Forum
Highlights from the 25th International Reid Bioanalytical Forum
We thank the other members of the International Reid Bioanalytical Forum organizing committee (Jon Bardsley, Rebecca Mogey...
Western blotting: evolution of an old analytical method to a new quantitative tool for biomarker measurements
Western blotting: evolution of an old analytical method to a new quantitative tool for biomarker measurements
Western blotting (WB) is a widely used laboratory technique for detecting specific proteins in biological matrices. Recent...
Inception and development of a LC–MS/MS assay for the multiplexed quantitation of nine human drug transporter biomarkers
Inception and development of a LC–MS/MS assay for the multiplexed quantitation of nine human drug transporter biomarkers
Background: It has become common practice to assess solute carrier transporter (SLC)-mediated drug–drug interactions (DDIs...
Utilizing droplet digital polymerase chain reaction for siRNA quantitation in rodent plasma and tissue via stem-loop reverse transcription
Utilizing droplet digital polymerase chain reaction for siRNA quantitation in rodent plasma and tissue via stem-loop reverse transcription
Background: siRNA is a promising therapeutic modality highlighted by several US FDA approvals since 2018, with many more o...
The synergy of nucleic acid amplification and miniaturized systems in enhancing liquid biopsy applications
The synergy of nucleic acid amplification and miniaturized systems in enhancing liquid biopsy applications
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
Development of LC–MS/MS method for cyanoenone triterpenoid determination to support CNS tissue distribution study
Development of LC–MS/MS method for cyanoenone triterpenoid determination to support CNS tissue distribution study
Aims: Cyanoenone triterpenoids penetrate the CNS, exhibiting biological activity via the nuclear factor E2-related factor ...
Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex
Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex
Background: This study aims to determine the concentrations of tramadol in earwax (μg/g) and urine (μg/ml) samples taken f...
Comprehensive performance evaluation of ligand binding assay–LC–MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442)
Comprehensive performance evaluation of ligand binding assay–LC–MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442)
Aims: AZD7442 is a combination SARS-CoV-2 therapy comprising two co-dosed monoclonal antibodies. Materials & methods: ...
Eliminating drug target interference with specific antibody or its F(ab′)2 fragment in the bridging immunogenicity assay
Eliminating drug target interference with specific antibody or its F(ab′)2 fragment in the bridging immunogenicity assay
Background: DB-1003 is a humanized anti-IgE monoclonal antibody with higher affinity than omalizumab. In the affinity capt...
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on June 19–23, 2023. Over 100...
Revolutionizing depression diagnosis: earwax analysis for cortisol and beyond
Revolutionizing depression diagnosis: earwax analysis for cortisol and beyond
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
Bioanalytical Quality Assurance: a Tesla with a trafficator?
Bioanalytical Quality Assurance: a Tesla with a trafficator?
The author has no financial involvement with any organization or entity with a financial interest in or financial conflict...
Molecularly imprinted electrochemical biosensor for thrombin detection by comparing different monomers
Molecularly imprinted electrochemical biosensor for thrombin detection by comparing different monomers
Aim: Investigating molecularly imprinted polymers (MIPs) in electrochemical biosensors for thrombin detection, an essentia...
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena
Covalent organic frameworks (COFs) have much potential in the field of analytical separation research due to their distinc...
GC–MS/MS analysis of synthetic cannabinoids 5F-MDMB-PICA and 5F-CUMYL-PICA in forensic cases
GC–MS/MS analysis of synthetic cannabinoids 5F-MDMB-PICA and 5F-CUMYL-PICA in forensic cases
Aim: Validate a method to quantify 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indole-3-carboxamide (5F-CUMYL-PICA) and ...
Greenness assessment of microextraction techniques in therapeutic drug monitoring
Greenness assessment of microextraction techniques in therapeutic drug monitoring
Aim: In this study, we evaluated the greenness and whiteness scores for microextraction techniques used in therapeutic dru...
Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis
Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis
While using the cloud environment for various functions has become commonplace, relatively little attention has been given...
Free hemoglobin determination at patients' bedside to evaluate hemolysis
Free hemoglobin determination at patients' bedside to evaluate hemolysis
Background: The authors report the relevance of using a point of care test (Helge®) for free hemoglobin determination and ...
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar
Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to eval...
Quality control of psychoactive substances in human breastmilk samples from a human milk bank by disposable pipette extraction–gas chromatography–mass spectrometry
Quality control of psychoactive substances in human breastmilk samples from a human milk bank by disposable pipette extraction–gas chromatography–mass spectrometry
The lack of data regarding infant exposure to drugs of abuse consumed by lactating mothers has become a major health conce...
Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study
Development and validation of a UPLC–MS/MS method for determination of SYHA1807 in a first-in-human study
Background: SYHA1807 is a novel lysine specific demethylase 1 inhibitor being developed for the treatment of small-cell lu...
Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children
Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children
Background: Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present th...
Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples
Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples
Background: A liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in rat dried blood spot (DB...
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies
Aim: Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compound...
Challenges and current advances in the methodology of thyroglobulin measurements
Challenges and current advances in the methodology of thyroglobulin measurements
Thyroglobulin (Tg) is a large protein secreted exclusively by the thyroid gland. In a clinical setting, it is measured for...
Meet the Editorial Board – an interview with Min Meng and transitions from small regional labs to global CRO
Meet the Editorial Board – an interview with Min Meng and transitions from small regional labs to global CRO
Min Meng received her PhD in biomedicinal chemistry from the School of Pharmacy, University of Maryland, in 1996. From 199...
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