Bioanalysis最新文献_第4页

Development of an LC-MS/MS assay to analyze a lipid-conjugated siRNA by solid phase extraction (SPE) in mouse plasma and tissue using a stable isotope labeled internal standard (SILIS). 建立了用稳定同位素标记内标（SILIS）固相萃取（SPE）分析小鼠血浆和组织中脂质偶联siRNA的LC-MS/MS分析方法。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-24 DOI: 10.1080/17576180.2025.2535953

Ethan J Sanford, Jianzhong Chen, Julia Tran, Ilia Korboukh, Guangnong Zhang

{"title":"Development of an LC-MS/MS assay to analyze a lipid-conjugated siRNA by solid phase extraction (SPE) in mouse plasma and tissue using a stable isotope labeled internal standard (SILIS).","authors":"Ethan J Sanford, Jianzhong Chen, Julia Tran, Ilia Korboukh, Guangnong Zhang","doi":"10.1080/17576180.2025.2535953","DOIUrl":"10.1080/17576180.2025.2535953","url":null,"abstract":"Background: Oligonucleotide therapeutics (ONTs) are a rapidly growing class of drug, with 20+ approved drugs on the market and more undergoing preclinical and clinical investigation for various indications. Many groups in the field are appending chemical modifications to modulate tissue specificity. Conjugation of long-chain fatty acids to siRNA molecules increases the hydrophobicity of the analyte and poses analytical challenges for extraction and LC-MS.Results: We report the development and optimization of an SPE extraction method for a lipid-conjugated siRNA. To improve assay quantitation by LC-MS, a stable isotope label internal standard (SILIS) was evaluated that enabled robust quantitation with high accuracy and precision (±5% in most cases).Conclusion: We demonstrate the performance of the assay in mouse plasma and tissue homogenates and apply the assay to the determination of tissue exposure and plasma PK profile for a novel lipid-conjugated siRNA molecule and suggest that a SILIS quantitation approach should be standard practice in siRNA bioanalysis.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"901-911"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706123","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

Navigating IVDR challenges for pharmacokinetic, anti-drug antibodies, and biomarker assays in early clinical research: a recommendation from the European Bioanalysis Forum. 在早期临床研究中应对IVDR对药代动力学、抗药物抗体和生物标志物测定的挑战：来自欧洲生物分析论坛的建议。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-04 DOI: 10.1080/17576180.2025.2540187

Philip Timmerman, Matthew Barfield, Jon G Bartlet, Peter Blattmann, Nils Boehm, Louis Christodoulou, Cecilie Freja Dalby Kjelgaard, Tracy Iles, Fabian Iltzsche, Marco Klinge, Leslie Henderson, Lee Monk, Robert Nelson, Yang Liu

{"title":"Navigating IVDR challenges for pharmacokinetic, anti-drug antibodies, and biomarker assays in early clinical research: a recommendation from the European Bioanalysis Forum.","authors":"Philip Timmerman, Matthew Barfield, Jon G Bartlet, Peter Blattmann, Nils Boehm, Louis Christodoulou, Cecilie Freja Dalby Kjelgaard, Tracy Iles, Fabian Iltzsche, Marco Klinge, Leslie Henderson, Lee Monk, Robert Nelson, Yang Liu","doi":"10.1080/17576180.2025.2540187","DOIUrl":"10.1080/17576180.2025.2540187","url":null,"abstract":"The European Bioanalysis Forum has observed increasing misclassification of pharmacokinetic, anti-drug antibody, and biomarker research assays not used for patient management under the European Union's In Vitro Diagnostic Regulation, despite their non-diagnostic intent in early clinical development. This misinterpretation, fueled by ambiguous protocol language, limited cross-functional awareness, and inconsistent national implementation, is leading to unnecessary delays in clinical trials and increased and non-added value regulatory burden. Through a structured evaluation involving a focus workshop and regional roadshows, the European Bioanalysis Forum identified some manageable origins of the issue and its operational consequences. This recommendation paper outlines these observations and wants to propose a pragmatic path forward. This includes clearer regulatory guidance to exempt noncommercial, non-diagnostic assays from In Vitro Diagnostic Regulation when not developed or intended as registered diagnostics. We also highlight the importance of stakeholder education and coordinated regulatory dialogue. These steps aim to preserve the regulator's intent of patient protection while enabling timely and efficient clinical research.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"889-892"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774656","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

Bioanalytical tandem mass spectrometry method for cinacalcet in human plasma: green assessment with advanced metrics. 人血浆中甲沙星的生物分析串联质谱法：先进指标的绿色评价。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-29 DOI: 10.1080/17576180.2025.2535945

Anil Kollapareddy, Kousrali Sayyad, Leela Prasad Kowtharapu, Naresh Konduru, Tanmoy Mondal, Mohan Varkolu, Sreedhar Gundekari

{"title":"Bioanalytical tandem mass spectrometry method for cinacalcet in human plasma: green assessment with advanced metrics.","authors":"Anil Kollapareddy, Kousrali Sayyad, Leela Prasad Kowtharapu, Naresh Konduru, Tanmoy Mondal, Mohan Varkolu, Sreedhar Gundekari","doi":"10.1080/17576180.2025.2535945","DOIUrl":"10.1080/17576180.2025.2535945","url":null,"abstract":"Aims: This study aims to address the clinical need for managing secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on dialysis and hypercalcemia in individuals with parathyroid carcinoma or primary hyperparathyroidism (PHPT) ineligible for parathyroidectomy. Cinacalcet, a key calcimimetic agent, targets the calcium-sensing receptor (CaSR) in the parathyroid gland to lower elevated parathyroid hormone (PTH) levels. The study focuses on developing a robust high-performance liquid chromatography tandem mass spectrometry method for cinacalcet quantification to support therapeutic monitoring and pharmacokinetics.Methods: A bioanalytical method using cinacalcet-D3 (CCT-D3) as an internal standard and tandem mass spectrometry in positive ion mode for accurate quantification employing Triple Quad Mass spectrometer in normal mode and a Zorbax Eclipse XDB-C18 column.Results: The method was comprehensively validated, demonstrating reliability through high precision, accuracy, linearity within the range of 0.300-150.00 ng/mL, and stability, all in compliance with established bioanalytical guidelines. Furthermore, its environmental sustainability was assessed using modern green chemistry evaluation metrics.Conclusion: This study presents a robust, selective LC-MS/MS assay for quantifying cinacalcet in human plasma. The assay demonstrates excellent linearity, precision, and recovery, making it suitable for pharmacokinetic studies, therapeutic drug monitoring, and bioequivalence or bioavailability assessments.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"857-870"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144727154","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

Latest developments in the detection and quantification of adrenaline: advances and clinical applications. 肾上腺素检测和定量的最新进展：进展和临床应用。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-12 DOI: 10.1080/17576180.2025.2546283

Tijana Mutić, Aleksandar Mijajlović, Vesna Stanković, Sladjana Djurdjić, Filip Vlahović, Dalibor Stanković

引用次数: 0

Evaluation of singlicate vs duplicate analysis in ligand binding assays: a case study with IFN-γ in mouse and NHP models. 配体结合分析中单酸与重复分析的评价：小鼠和NHP模型中IFN-γ的案例研究。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-21 DOI: 10.1080/17576180.2025.2535948

Ruwini D Rajapaksha, Freya van Kesteren, Philip J Kuehl, John T Farmer

{"title":"Evaluation of singlicate vs duplicate analysis in ligand binding assays: a case study with IFN-γ in mouse and NHP models.","authors":"Ruwini D Rajapaksha, Freya van Kesteren, Philip J Kuehl, John T Farmer","doi":"10.1080/17576180.2025.2535948","DOIUrl":"10.1080/17576180.2025.2535948","url":null,"abstract":"Background: The use of duplicate analysis in biomarker assays is a standard practice. While it does not inherently increase variability or contribute to assay failure, it can reveal the high variability associated with manual pipetting, thereby highlighting potential issues within the assy.Research design and methods: This study evaluated the reliability of singlicate analysis compared to duplicate analysis for interferon-gamma (IFN-γ) assays using ELISA in mouse and non-human primate (NHP) serum samples. Assay performance was assessed across 50 plates, with results analyzed for minimum required dilution (MRD), standard curve linearity, surrogate sample accuracy, recovery, precision, and variability between analysts, including both an experienced and a novice analyst.Results: There were minimal differences in relative accuracy, and precision between singlicate and duplicate analysis, with CVs less than 5% for both methods. Singlicate and duplicate-generated standard curves were strongly correlated (NHP R2 = 0.9995, mouse R2 = 1.0000). Analyst variability had less impact on singlicate analysis, with lower inter-analyst CVs (1.0-6.5%) compared to duplicate analysis (5.0-7.5%).Conclusions: These findings underscore the robustness of singlicate analysis. A workflow for singlicate assay validation is proposed, demonstrating its potential to streamline biomarker assay development while ensuring regulatory compliance. This study supports the adoption of singlicate analysis as a viable alternative to conventional duplicate methods for biomarker assays.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"871-880"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144673878","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

Why traditional validation may fall short for artificial intelligence in bioanalysis: a perspective from the European Bioanalysis Forum. 为什么传统的验证可能会在生物分析中的人工智能不足：来自欧洲生物分析论坛的观点。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-29 DOI: 10.1080/17576180.2025.2535219

Philip Timmerman, Katja Zeiser, Connor Walker, Robert Nelson, Michaela Golob, Matthew Barfield

引用次数: 0

A validated method for the determination of doxofylline and its pharmacokinetic application in healthy volunteers. 一种有效的多索茶碱测定方法及其在健康志愿者体内的药动学应用。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-30 DOI: 10.1080/17576180.2025.2535950

Yonghua Yu, Danrui Liu, Hangyu Zhao, Menglong Dai, Yu Hu, Kaiwei Luo, Huina Zhang

{"title":"A validated method for the determination of doxofylline and its pharmacokinetic application in healthy volunteers.","authors":"Yonghua Yu, Danrui Liu, Hangyu Zhao, Menglong Dai, Yu Hu, Kaiwei Luo, Huina Zhang","doi":"10.1080/17576180.2025.2535950","DOIUrl":"10.1080/17576180.2025.2535950","url":null,"abstract":"Background: Current HPLC-based methods for doxofylline analysis lack speed and precision. A rapid, specific, and sensitive UPLC-MS/MS method was developed for the determination of doxofylline in this study.Research design and methods: This method was fully validated and doxophylline-d4 was used as an internal standard. A Kinetex-C18 column (EVO 100Å, 50 × 2.1 mm, 5 μm) was used for the separation procedure, with mobile phases consisting of 0.3% formic acid (A) and 90% acetonitrile solution with 0.3% formic acid (B). The total runtime of the gradient elution procedure was 2.6 minutes. The mass spectrometry analysis was carried out employing a multiple reaction monitoring model and using the transitions of m/z 267.000→181.000 for doxofylline and m/z 271.200→181.100 for the internal standard.Results: The linear range of detection for doxophylline was between 20.0 to 16,000 ng/mL. The intra-batch accuracy deviations of each concentration level ranged from -8.0% to 2.5%, while the intra-batch precisions ranged from 1.3% to 9.0%. And the inter-batch accuracy deviations were -5.8% ~0.8%, while the inter-batch precisions were 2.2% ~7.0%.Conclusions: This method was applied to pharmacokinetic clinical trials of single oral administration of doxophylline tablets successfully.Clinical trial registration: www.clinicaltrials.gov identifier is CTR20240006 and CTR20233665.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"847-855"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741060","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

Use of surrogate matrices in bioanalytical preclinical safety testing using immunoassay methods: a recommendation from the European Bioanalysis Forum. 使用免疫分析方法在生物分析临床前安全性测试中使用替代基质：来自欧洲生物分析论坛的建议。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-09 DOI: 10.1080/17576180.2025.2545136

Richard Hughes, Gregor Jordan, Yvonne Katterle, Birgit Jaitner, Charles Britten, Arnout Gerritsen, Deepa Reddy Bandi, Tobias Haslberger, Tinie van Boekel, Jens Sigh, Michaela Golob, Kyra J Cowan, Philip Timmerman

{"title":"Use of surrogate matrices in bioanalytical preclinical safety testing using immunoassay methods: a recommendation from the European Bioanalysis Forum.","authors":"Richard Hughes, Gregor Jordan, Yvonne Katterle, Birgit Jaitner, Charles Britten, Arnout Gerritsen, Deepa Reddy Bandi, Tobias Haslberger, Tinie van Boekel, Jens Sigh, Michaela Golob, Kyra J Cowan, Philip Timmerman","doi":"10.1080/17576180.2025.2545136","DOIUrl":"10.1080/17576180.2025.2545136","url":null,"abstract":"The use of blank authentic matrix for bioanalytical method validation and sample analysis has long been standard practice within the bioanalytical community and is considered a requirement under current guidelines for bioanalytical method validation. However, this practice has been increasingly challenged as there are scientifically valid alternatives to replace blank authentic matrices with surrogate matrices. The use of authentic matrices from preclinical animal species conflicts with the ethical 3Rs principles (Replacement, Reduction, and Refinement), a concern that the European Bioanalysis Forum has been addressing for years through data-driven advocacy. In this manuscript, the EBF presents experimental data supporting the use of surrogate matrices in preclinical assays for immunoassay formats. This approach significantly reduces the reliance on authentic matrices, while preserving the quality and integrity of bioanalytical data. The findings advocate for revisiting or clarifying regulatory guidelines, such as ICH M10, to more widely accept the use of surrogate matrices, ensuring alignment with ethical standards without compromising scientific rigor.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"893-898"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803356","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

Qualification of a electrochemiluminescence assay for the detection of human urinary neurotrophin receptor p75. 用于检测人尿神经营养因子受体p75的电化学发光试验的鉴定。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-07-09 DOI: 10.1080/17576180.2025.2529147

Matthew J Lawless, Nikki Chan, Kruti Patel, Michelle Wang, David C Colter

引用次数: 0

The case for calibration-free concentration analysis. 免校准浓度分析案例。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-12 DOI: 10.1080/17576180.2025.2517530

Shannon D Chilewski

引用次数: 0