IF 1.9 4区医学

Bioanalysis Pub Date : 2025-04-09 DOI: 10.1080/17576180.2025.2487377

Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman

{"title":"Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.","authors":"Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman","doi":"10.1080/17576180.2025.2487377","DOIUrl":"https://doi.org/10.1080/17576180.2025.2487377","url":null,"abstract":"The European Bioanalysis Forum, in discussions with cross-industry experts from pharmaceutical, biotech, and contract research organizations, is continuing the challenge of the traditional 3-Tier immunogenicity testing strategy, proposing a simpler, context-driven 1-Tier approach, a recent paradigm shift that emphasizes clinical relevance and the impact of anti-drug antibodies over mere incidence. In a workshop at the 17th annual Open Symposium, the meeting highlighted using signal-to-noise ratios to assess low-level ADA responses and addressed challenges such as nonspecific binding and assay reliability. Participants debated the need for continued confirmatory testing, and that it should be performed on a case-by-case basis. The shift aims to improve clinical testing strategies while reducing complexity, promoting data-driven decisions. Case studies, particularly from high-risk molecules, will guide implementation. Overall, there's strong support for the 1-Tier approach, but its success depends on robust data, industry collaboration, and regulatory approval.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-4"},"PeriodicalIF":1.9,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Strategic approaches to assess and quantify the oxidative stress biomarkers in complex biological systems. 评估和量化复杂生物系统中氧化应激生物标志物的策略方法。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-04-04 DOI: 10.1080/17576180.2025.2486929

Padmasri Sai Nandana Aravapally, Naveen Chandrasekar, Arvind Verma, Ravi P Shah

{"title":"Strategic approaches to assess and quantify the oxidative stress biomarkers in complex biological systems.","authors":"Padmasri Sai Nandana Aravapally, Naveen Chandrasekar, Arvind Verma, Ravi P Shah","doi":"10.1080/17576180.2025.2486929","DOIUrl":"https://doi.org/10.1080/17576180.2025.2486929","url":null,"abstract":"Oxidative stress (OS) is an emerging research area in clinical and biological sciences due to its association with various diseases and physiological processes. OS occurs when there is an imbalance between the production of reactive oxygen species (ROS) and the body's ability to neutralize or repair the damage caused. Chronic oxidative stress is linked to diseases like diabetes, cardiovascular diseases, cancer, and neurodegenerative disorders. Accurate monitoring of OS is crucial for diagnosing diseases, evaluating disease progression, and predicting clinical results. Despite challenges in measuring free radicals due to their short half-life and low concentrations, it can be indirectly assessed through biomarkers like lipid peroxidation, DNA damage, and protein oxidation. The most effective analytical techniques for assessing OS biomarkers in various biological fluids were developed. Furthermore, an in-depth exploration of these various analytical methodologies, underscoring their sensitivity, specificity, and reliability in detecting low concentrations of biomarkers across complex matrices is necessary. A comprehensive literature search was conducted using databases such as Google Scholar, PubMed and Reaxys to identify relevant studies on OS biomarkers. This review explores the evolution of these techniques, highlighting advancements in sample preparation procedures and the specifications of each technique, offering a thorough evaluation of biomarker analysis.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-14"},"PeriodicalIF":1.9,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Feedback from the 10th European Bioanalysis Forum Young Scientist Symposium and from the Science Café discussions on sustainability in bioanalysis. 来自第十届欧洲生物分析论坛青年科学家研讨会和科学咖啡馆关于生物分析可持续性的讨论的反馈。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-25 DOI: 10.1080/17576180.2025.2479963

Sanam Ahmad, Fabian Gärtner, Rosie Penford, Lisa Wolter, Sonya Belle, Alexandra Bushby, Mariana Carneiro Da Cunha, Brian Dan, Andrea Di Ianni, Caroline Dumolyn, Marie Sole Giordano, Eva Hanckmann, Jayshree Maher, Elisa Milandri, Kyriel Pineault, Amelia Roberts, Marie Reille-Seroussi, Sara Russo, Manca Spendal, Claire Szuster, Kevin Vandenbroucke, Aline Vollmer, Friederike Vogt, Simon Wellenberg, Philip Timmerman

{"title":"Feedback from the 10th European Bioanalysis Forum Young Scientist Symposium and from the Science Café discussions on sustainability in bioanalysis.","authors":"Sanam Ahmad, Fabian Gärtner, Rosie Penford, Lisa Wolter, Sonya Belle, Alexandra Bushby, Mariana Carneiro Da Cunha, Brian Dan, Andrea Di Ianni, Caroline Dumolyn, Marie Sole Giordano, Eva Hanckmann, Jayshree Maher, Elisa Milandri, Kyriel Pineault, Amelia Roberts, Marie Reille-Seroussi, Sara Russo, Manca Spendal, Claire Szuster, Kevin Vandenbroucke, Aline Vollmer, Friederike Vogt, Simon Wellenberg, Philip Timmerman","doi":"10.1080/17576180.2025.2479963","DOIUrl":"https://doi.org/10.1080/17576180.2025.2479963","url":null,"abstract":"Since 2014, the European Bioanalysis Forum has organized the Young Scientist Symposium, providing early-career scientists with unique development opportunities. By fostering a peer community, this initiative has successfully lowered barriers to engagement in cross-company, pre-competitive interactions. Since 2018, the symposium has included the Science Café roundtable, further reinforcing the European Bioanalysis Forum's commitment to supporting young scientists beyond their scientific expertise by promoting broader professional development.This manuscript summarizes discussions from the 10th Young Scientist Symposium, held in Hasselt, Belgium, from May 15-17, 2024. The symposium featured presentations on new technologies, biomarker assays, troubleshooting, and microsampling. Additionally, it provides insights from the Science Café discussions, which focused on sustainability in the bioanalytical laboratory.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A chiral HPLC and pharmacokinetic approach of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide. 1-（4-溴苯基）-6,7-二甲氧基-3,4-二氢异喹啉-2(1H)-磺酰胺的手性高效液相色谱及药代动力学研究。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-24 DOI: 10.1080/17576180.2025.2481023

Peddaguravagari Mounika, Mariya Shelby, Chethan K S, Honnavalli Yogish Kumar, Bannimath Gurupadayya

{"title":"A chiral HPLC and pharmacokinetic approach of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide.","authors":"Peddaguravagari Mounika, Mariya Shelby, Chethan K S, Honnavalli Yogish Kumar, Bannimath Gurupadayya","doi":"10.1080/17576180.2025.2481023","DOIUrl":"https://doi.org/10.1080/17576180.2025.2481023","url":null,"abstract":"Aim: The main purpose of the study is to establish Bioanalytical method development for enantiomeric divergence and Stereoselective Pharmacokinetic activity of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide(B06).Background: Isoquinoline derivatives have various activities like anticancer, anti-convulsant etc. The proposed project is mainly focused on anti-cancer activity of the synthesized B-06 compound as it shown very good cytotoxicity activity on MBA-MD-231 and MCF-7 cell lines by using SRB assay.Method: The specified project was completed with HPLC and an amylose chiral column. The bioanalytical approach was developed and tested using Wister Albino rats in compliance with USFDA Guidelines and expanded to include pharmacokinetic activities.Result: Data that had previously been published was used to design the B06 compound. RT of 9.578 and 7.076 minutes were observed for (R) &; (S) B06 Compound. Within-run and between-run precision for S-enantiomer varied from 0.28 to 6.078%, while R-enantiomer was found to range from 0.34 to 6.08%. Recovery rates ranged from 80.06% to 92.60% for both enantiomers. Pharmacokinetic investigations were developed and validated by using PKSolver software with Microsoft Excel.Conculsion: We successfully established optimized bioanalytical method for pharmacokinetic study were both the enantiomers were properly separated. In pharmacokinetic activity we found that the enantiomers are non-stereoselective having same absorption rate.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-9"},"PeriodicalIF":1.9,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Advances in green sample preparation methods for bioanalytical laboratories focusing on drug analysis. 以药物分析为重点的生物分析实验室绿色样品制备方法的进展。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-24 DOI: 10.1080/17576180.2025.2481026

Rajeev Jain, Bharti Jain, Lateefa A Al-Khateeb, Sarah Alharthi, Mohammad M Ghoneim, Mohamed AbdElrahman, Abdullah S Alanazi

{"title":"Advances in green sample preparation methods for bioanalytical laboratories focusing on drug analysis.","authors":"Rajeev Jain, Bharti Jain, Lateefa A Al-Khateeb, Sarah Alharthi, Mohammad M Ghoneim, Mohamed AbdElrahman, Abdullah S Alanazi","doi":"10.1080/17576180.2025.2481026","DOIUrl":"10.1080/17576180.2025.2481026","url":null,"abstract":"Bioanalytical laboratories face significant challenges in sample preparation due to the complexity of biological matrices and the low concentrations of target analytes. This review focuses on advances in green sample preparation (GSP) techniques tailored to meet these challenges while promoting sustainability. Innovations in sorbents, including metal-organic frameworks (MOFs), magnetic nanoparticles (MNPs), sol-gel-based materials, molecularly imprinted polymers (MIPs), carbon-based materials, and natural sorbents like cellulose and kapok fiber, have enhanced extraction efficiency and selectivity. Green solvents such as deep eutectic solvents (DES), ionic liquids (ILs), supramolecular solvents (SUPRAs), and switchable hydrophilicity solvents (SHSs) further reduce environmental impact by minimizing toxic solvent use. This review highlights their use in drug analysis, emphasizing their roles in enhancing extraction efficiency, selectivity, and environmental sustainability. Recent applications demonstrate the integration of these sorbents and solvents into bioanalytical workflows, significantly improving analytical performance while adhering to Green Analytical Chemistry (GAC) principles. It is anticipated that this comprehensive review will aid scholars in the formulation of selective, rapid, environmentally friendly, straightforward, sensitive, and precise analytical methodologies for bioanalysis, thereby promoting innovation and sustainability within drug analysis protocols.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-20"},"PeriodicalIF":1.9,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Conquering PROTAC molecular design and drugability. 攻克PROTAC分子设计和药物可药性。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-20 DOI: 10.1080/17576180.2025.2481021

Ritesh P Bhole, Sonali Labhade, Shilendra S Gurav

引用次数: 0

Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats. ADA分析中的单酸分析：在重复和单酸格式下比较分析性能。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-11 DOI: 10.1080/17576180.2025.2464421

Zhihua Jiang

引用次数: 0

Molecularly imprinted polymer-based paper spray ionization mass spectrometry: shaping the future of bioanalysis. 分子印迹聚合物基纸喷雾电离质谱：塑造生物分析的未来。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-26 DOI: 10.1080/17576180.2025.2472735

Almir Custodio Batista Junior, Lanaia Ítala Louzeiro Maciel, Yuri Arrates Rocha, João Victor Borges Assis, Andrea Rodrigues Chaves

引用次数: 0

Enhancing clinical research with pharmacogenomics: a practical perspective. 用药物基因组学加强临床研究：一个实用的观点。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-03-21 DOI: 10.1080/17576180.2025.2481019

Xiaolong Tom Zhang, Jacob Blacutt, Thomas Lloyd, Mike Mencer, Vicky Pratt, Jayaprakash Kotha, Lona Sheeran, Sherilyn Adcock

{"title":"Enhancing clinical research with pharmacogenomics: a practical perspective.","authors":"Xiaolong Tom Zhang, Jacob Blacutt, Thomas Lloyd, Mike Mencer, Vicky Pratt, Jayaprakash Kotha, Lona Sheeran, Sherilyn Adcock","doi":"10.1080/17576180.2025.2481019","DOIUrl":"10.1080/17576180.2025.2481019","url":null,"abstract":"Pharmacogenomics (PGx) is transforming therapeutic development by providing insights into how genetic variations influence drug response, safety, and efficacy. This review provides a structured analysis of PGx in clinical research, beginning with an overview of key genes involved in drug metabolism, transport, and targets. Following this, it examines strategies for identifying PGx-relevant genes, including phenotype-driven, hypothesis-driven, population-focused, and clinical-driven approaches. Technical platforms such as PCR, MassARRAY, and next-generation sequencing are analyzed for their suitability in PGx studies. The discussion then shifts to assay validation processes, covering both analytical and clinical validation, to ensure data reliability in clinical trials. Finally, regulatory expectations for PGx in clinical trials are discussed, focusing on key requirements across all phases of drug development. This review aims to provide a clear and practical framework for integrating PGx into clinical research to enhance drug safety, efficacy, and personalized medicine.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"399-411"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The development and evolution of biological AMS at Livermore: a perspective. 利弗莫尔生物AMS的发展和演变：一个视角。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-04 DOI: 10.1080/17576180.2025.2460391

Graham Bench

引用次数: 0

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