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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on 19–23 June 2023. Over 1000...
Feedback from the Science Café roundtables at the ninth European Bioanalysis Forum Young Scientist Symposium: optimizing the work–life balance in a bioanalytical laboratory
Feedback from the Science Café roundtables at the ninth European Bioanalysis Forum Young Scientist Symposium: optimizing the work–life balance in a bioanalytical laboratory
As part of the European Bioanalysis Forum’s continued commitment to develop young scientists beyond their scientific skill...
The case for bioanalytical analyzer
The case for bioanalytical analyzer
The author has no financial involvement with any organization or entity with a financial interest in or financial conflict...
Observations from a decade of oligonucleotide bioanalysis by LC-MS
Observations from a decade of oligonucleotide bioanalysis by LC-MS
There is a growing need for efficient bioanalysis of oligonucleotide therapeutics. This broad class of molecules presents ...
BiSim Tool: a binding simulation tool to aid and simplify ligand-binding assay design and development
BiSim Tool: a binding simulation tool to aid and simplify ligand-binding assay design and development
Ligand-binding assays (LBAs) rely on the reversible, noncovalent binding between the analyte of interest and the assay rea...
Assessment of matrix effect in quantitative LC-MS bioanalysis
Assessment of matrix effect in quantitative LC-MS bioanalysis
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
An interview with Bioanalysis: speaking with the 2023 International Reid Bioanalytical Forum bursary award winners, part 1
An interview with Bioanalysis: speaking with the 2023 International Reid Bioanalytical Forum bursary award winners, part 1
The authors have no financial involvement with any organization or entity with a financial interest in or financial confli...
Enzymes as indispensable markers in disease diagnosis
Enzymes as indispensable markers in disease diagnosis
Enzymes have been used for disease diagnosis for many decades; however, advancements in technology like ELISA and flow cyt...
Development and validation of bioanalytical methods to support clinical study of disitamab vedotin
Development and validation of bioanalytical methods to support clinical study of disitamab vedotin
Disitamab vedotin (RC48), a humanized anti-HER2 antibody conjugated with monomethyl auristatin E (MMAE), is the first anti...
The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum
The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum
This manuscript reports back from the discussion in the European Bioanalysis Forum community on the challenges observed wh...
Pharmacokinetics and apparent Michaelis constant for metabolite conversion of sorafenib in healthy and hepatocellular carcinoma-bearing rats
Pharmacokinetics and apparent Michaelis constant for metabolite conversion of sorafenib in healthy and hepatocellular carcinoma-bearing rats
Aim: Investigation of the pharmacokinetics of sorafenib (SRF) in rats with hepatocellular carcinoma (HCC). Methods: A repr...
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners – part 2
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners – part 2
The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) bet...
A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
Background: Measuring pharmacodynamic biomarkers near the therapeutic site of action presents considerable challenges for ...
Determination of meropenem in capillary plasma microsamples using LC–MS/MS
Determination of meropenem in capillary plasma microsamples using LC–MS/MS
Background: The measurement of meropenem plasma concentrations is employed for dosing regimen individualization. The aim o...
In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method
In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method
This study was conducted to compare dissolution profiles of four Jordanian registered sildenafil (SDF) products to the ori...
Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control
Novel assay format for total anti-adeno-associated virus antibody detection with low capsid consumption and built-in specificity control
Aim: To develop an assay format for detection of total anti-adeno–associated virus 2 (AAV2) antibodies with low capsid mat...
Determination of carbamazepine in fingerprints: a feasibility study to evaluate adherence in epilepsy patients
Determination of carbamazepine in fingerprints: a feasibility study to evaluate adherence in epilepsy patients
Background: Fingerprint drug concentrations can be used as a noninvasive and convenient alternative to evaluate adherence ...
An LC–MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma
An LC–MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma
We have developed and validated a novel LC–MS/MS method for the simultaneous quantification of ZEN-3694 and its active met...
Use of RNA biomarkers in the antidoping field
Use of RNA biomarkers in the antidoping field
There is growing evidence that various RNA molecules can serve as biomarkers for clinical diagnoses. Over the last decade,...
Determination of aloesone in rat plasma by LC–MS/MS spectrometry and its application in a pharmacokinetic study
Determination of aloesone in rat plasma by LC–MS/MS spectrometry and its application in a pharmacokinetic study
Aim: We aimed to develop a rapid and accurate LC–MS/MS method for determining the concentration of aloesone in rat plasma,...
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...
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...
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...
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...
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...
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