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Development and validation of highly sensitive ligand binding assay to measure soluble DLL3 concentration in human serum. 高灵敏度配体结合测定法测定人血清中可溶性DLL3浓度的建立与验证。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-24 DOI: 10.1080/17576180.2025.2518047
Masanobu Nishidate, Chisato Yanagisawa, Hiroki Irie, Kayo Aida, Takashi Miyayama, Kimio Terao
{"title":"Development and validation of highly sensitive ligand binding assay to measure soluble DLL3 concentration in human serum.","authors":"Masanobu Nishidate, Chisato Yanagisawa, Hiroki Irie, Kayo Aida, Takashi Miyayama, Kimio Terao","doi":"10.1080/17576180.2025.2518047","DOIUrl":"10.1080/17576180.2025.2518047","url":null,"abstract":"<p><strong>Background: </strong>Delta-like protein 3 (DLL3) is considered to inhibit the Notch pathway in the tumorigenesis of small cell lung cancer (SCLC) and other neuroendocrine carcinomas, making it a potential therapeutic target in the treatment of cancer. Since the soluble form (sDLL3) is expected to be useful for predicting the status of DLL3 expression on tumors, analytical methods to measure sDLL3 are required.</p><p><strong>Research design and methods: </strong>Assay methods using ELISA and the SMCxPRO platform were developed to analyze sDLL3 concentration in human serum. The performance of the ELISA was evaluated and the SMCxPRO assay was fully validated, and the comparability of the 2 assays was assessed.</p><p><strong>Results: </strong>The performance of the ELISA was acceptable, and in the SMCxPRO assay validation, all pre-defined validation acceptance criteria were met. The 2 assays were comparable within the range of quantification. Concentrations ranged from below the limit of quantification (<1.00 pg/mL) to 18.0 pg/mL for healthy volunteers and from 1.27 pg/mL to 519 pg/mL for SCLC patients by SMCxPRO assay.</p><p><strong>Conclusions: </strong>Two sensitive assay methods to measure sDLL3 in human serum were successfully established. These assays have potential as novel blood-based assays to assess the status of DLL3 expression on tumors in humans.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"725-736"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473876","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
Impact of drug concentration and ADA assay drug tolerance on the assessment and correlation of titer and signal to noise. 药物浓度和ADA测定对滴度和信噪比评估及相关性的影响。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-07-14 DOI: 10.1080/17576180.2025.2529146
Lili Guo, Kevin Carleton, Yong Jiang, Christopher Ehlinger
{"title":"Impact of drug concentration and ADA assay drug tolerance on the assessment and correlation of titer and signal to noise.","authors":"Lili Guo, Kevin Carleton, Yong Jiang, Christopher Ehlinger","doi":"10.1080/17576180.2025.2529146","DOIUrl":"10.1080/17576180.2025.2529146","url":null,"abstract":"<p><strong>Background/aim: </strong>The three-tiered testing strategy for an anti-drug antibody (ADA) assay is a common practice for assessing the immunogenicity to therapeutic products. Efforts to streamline the ADA testing process led to proposals of using signal to noise (<i>S/N</i>) as a substitute for titer when determining ADA magnitude. This study aims to identify the critical factors that may influence the correlation of <i>S/N</i> and titer.</p><p><strong>Method/result: </strong>Experimental and clinical ADA datasets were examined to assess how drug concentration and the assay drug tolerance affect the measurement and correlation of <i>S/N</i> and titer. Under various experimental conditions the influence of drug on titer was minimal across a range of drug concentrations. However, drug presence affected the <i>S/N</i>, particularly when drug concentrations approached the assay drug tolerance. Clinical ADA datasets showed a moderate to strong correlation between <i>S/N</i> and titer, demonstrating similar patterns of drug impact on both measurements, as observed in the experimental data.</p><p><strong>Conclusion: </strong>The presence of drug in clinical samples and the drug tolerance of the ADA assay simultaneously influence the measurement and correlation of <i>S/N</i> and titer. The fold difference between drug tolerance and the maximum drug concentration in samples is a key factor in determining this correlation.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"787-793"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367090/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636068","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
17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays. 第17届GCC闭门论坛:综合生物分析,以患者为中心的采样,新兴技术,数据完整性,样品校准,ELISpot数据差异,交叉验证协调,ADA检测的超灵敏平台,远程监管评估,PCR脱落检测和生物标志物组织检测。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-08-18 DOI: 10.1080/17576180.2025.2529119
Jennifer Zimmer, Mark O'dell, Derrick Johnson, Amanda Hays, Shashank Gorityala, Magdalena Tary-Lehmann, Katherine Malone, Manisha Diaz, Tao Xu, Varun Dwivedi, Dawn Dufield, Tracy Iles, Daniel Sikkema, Ritankar Majumdar, Nathan Riccitelli, Moucun Yuan, Steve Lowes, Aihua Liu, Katie Matys, Annelies Turksma, John Pirro, Jerome Bergeron, Shane Karnik, Troy Voelker, Danielle Salha, Gregory Reynolds, Corbyn Lamy, Mathilde Yu, Wei Garofolo, Sankeetha Nadarajah, Amanda Leskovar, Mario Pellerin, Rathna Veeramachaneni, Cheikh Kane, Allan Xu, Elizabeth Hyer, Annika Carlsson, Mitesh Sanghvi, Elizabeth Dompkowski, Stephen Rundlett, Joseph Bower, Adriane Spytko, Jia Liu, Weihua Gu, Agostinho Rocha, Kyla O'Brien, Xinping Fang
{"title":"17th GCC Closed Forum: Integrative Bioanalysis, Patient-centric Sampling, Emerging Technologies, Data Integrity, Sample Reconciliation, Discrepancies of ELISpot Data, Cross-validation Harmonization, Ultrasensitive Platforms for ADA Assays, Remote Regulatory Assessments, Shedding Assays by PCR, and Biomarker Tissue Assays.","authors":"Jennifer Zimmer, Mark O'dell, Derrick Johnson, Amanda Hays, Shashank Gorityala, Magdalena Tary-Lehmann, Katherine Malone, Manisha Diaz, Tao Xu, Varun Dwivedi, Dawn Dufield, Tracy Iles, Daniel Sikkema, Ritankar Majumdar, Nathan Riccitelli, Moucun Yuan, Steve Lowes, Aihua Liu, Katie Matys, Annelies Turksma, John Pirro, Jerome Bergeron, Shane Karnik, Troy Voelker, Danielle Salha, Gregory Reynolds, Corbyn Lamy, Mathilde Yu, Wei Garofolo, Sankeetha Nadarajah, Amanda Leskovar, Mario Pellerin, Rathna Veeramachaneni, Cheikh Kane, Allan Xu, Elizabeth Hyer, Annika Carlsson, Mitesh Sanghvi, Elizabeth Dompkowski, Stephen Rundlett, Joseph Bower, Adriane Spytko, Jia Liu, Weihua Gu, Agostinho Rocha, Kyla O'Brien, Xinping Fang","doi":"10.1080/17576180.2025.2529119","DOIUrl":"10.1080/17576180.2025.2529119","url":null,"abstract":"<p><p>The 17th GCC Closed Forum was held in San Antonio, TX, USA, on 10<sup>th</sup> May 2024. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The topics discussed at the meeting included integrative bioanalysis, patient-centric sampling, emerging technologies, data integrity, sample reconciliation efforts, discrepancies of ELISpot data, cross-validation harmonization, ultrasensitive platforms for immunogenicity assays, remote regulatory assessments, shedding assays by qPCR/dPCR, and biomarker assays. Conclusions and consensus from discussions of these topics are included in this article.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 12","pages":"769-786"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367079/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871206","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
Impact of positive control binding properties on anti-drug antibody assay performance. 阳性对照结合特性对抗药物抗体测定性能的影响。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-12 DOI: 10.1080/17576180.2025.2518045
Trinidad Arceo, Ben Andrews, Jennifer Getz, Sara Haile, Mauricio Maia, Yuan Song
{"title":"Impact of positive control binding properties on anti-drug antibody assay performance.","authors":"Trinidad Arceo, Ben Andrews, Jennifer Getz, Sara Haile, Mauricio Maia, Yuan Song","doi":"10.1080/17576180.2025.2518045","DOIUrl":"10.1080/17576180.2025.2518045","url":null,"abstract":"<p><strong>Background: </strong>Monitoring anti-drug antibodies (ADAs) is a critical component of recombinant protein drug development. Positive controls in ADA assays are essential for evaluating assay quality, yet the influence of their binding properties on assay performance is not well understood.</p><p><strong>Research design and methods: </strong>We evaluated a panel of surrogate positive controls with varying binding characteristics to investigate how their affinity and kinetic parameters impact ADA assay performance. Binding properties were measured using Bio-Layer Interferometry (BLI), and assays were evaluated for relative sensitivity and drug tolerance. This was a laboratory-based study; no human or animal subjects were involved.</p><p><strong>Results: </strong>We observed a correlation between higher affinity (lower K<sub>D</sub> (equilibrium dissociation constant)) and lower k<sub>off</sub> (off-rate constant) with increased relative assay sensitivity. However, no consistent relationship was found between these binding parameters and drug tolerance. These findings suggest that binding kinetics of the positive control can significantly influence sensitivity but may not predict drug tolerance.</p><p><strong>Conclusions: </strong>Understanding the relationship between positive control binding properties and ADA assay performance can support the selection of reagents that optimize sensitivity. Limitations include the use of surrogate positive controls, which may not fully replicate the complexity of clinical ADA responses.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"701-706"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274135","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
Quantitation of TAK-981 in human plasma via LC-MS/MS and its application in clinical trials. LC-MS/MS法测定人血浆中TAK-981的含量及其在临床试验中的应用
IF 1.8 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-12 DOI: 10.1080/17576180.2025.2518048
Feng Yin, Ran Ye, Anson Pierce, John Gibbs, Mike Baratta
{"title":"Quantitation of TAK-981 in human plasma via LC-MS/MS and its application in clinical trials.","authors":"Feng Yin, Ran Ye, Anson Pierce, John Gibbs, Mike Baratta","doi":"10.1080/17576180.2025.2518048","DOIUrl":"10.1080/17576180.2025.2518048","url":null,"abstract":"<p><strong>Aim: </strong>TAK-981 is a highly effective and selective inhibitor of the small ubiquitin-like modifier (SUMO) activating enzyme, and it promotes the expression of type I interferons (IFN-Is). Developing a sensitive bioanalytical assay for quantitating TAK-981 is essential in the clinical investigations for oncology drug development.</p><p><strong>Materials & methods: </strong>TAK-981 and its stable isotope labeled compound (TAK-981<sup>13</sup>C<sub>4</sub>, <sup>15</sup>N<sub>2</sub>) as the internal standard were employed in this LC-MS/MS assay.</p><p><strong>Results: </strong>This assay was successfully validated from 0.1 ng/mL to 100 ng/mL with good accuracy and precision and has been applied to support clinical studies.</p><p><strong>Conclusion: </strong>A sensitive and robust LC-MS/MS assay was validated for TAK-981 in human plasma for the first time.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"795-805"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274136","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
Liquid chromatography-tandem mass spectrometry methods for clinical quantitation of antibiotics. 临床抗生素定量的液相色谱-串联质谱法。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-07-09 DOI: 10.1080/17576180.2025.2529149
Xingrui He, Wenqian Zhang, Feifan Xie
{"title":"Liquid chromatography-tandem mass spectrometry methods for clinical quantitation of antibiotics.","authors":"Xingrui He, Wenqian Zhang, Feifan Xie","doi":"10.1080/17576180.2025.2529149","DOIUrl":"10.1080/17576180.2025.2529149","url":null,"abstract":"<p><p>The accurate quantification of antibiotics in biological matrices is pivotal for supporting individualized medication, optimizing antibiotics therapy and addressing the global crisis of antimicrobial resistance (AMR). LC-MS/MS has emerged as the gold standard for clinical antibiotic quantification, particularly valued for its accuracy, multiplexing efficiency, and compatibility with complex sample types. This review provides a comprehensive overview of the principles, methodologies, and clinical applications of LC-MS/MS in antibiotic quantification, with a focus on its role in therapeutic drug monitoring (TDM), pharmacokinetics (PK), and epidemiological studies. Key challenges, including sample preparation and matrix effects, are critically discussed. Tailored strategies for analyzing diverse antibiotic classes (e.g. β-lactams, aminoglycosides, colistins, macrolides, and glycopeptides) are highlighted by considering their physicochemical properties, including polarity, acid-base characteristics, and structural complexity. Furthermore, emerging trends in automation, high-resolution mass spectrometry, and quality control frameworks are outlined to guide future advancements. By bridging technological innovation with clinical needs, LC-MS/MS continues to be a cornerstone of precision medicine and a vital tool in global AMR mitigation efforts.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"817-833"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590393","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
Whole blood stability in bioanalytical method validation: updated recommendations from the European Bioanalysis Forum. 生物分析方法验证中的全血稳定性:来自欧洲生物分析论坛的最新建议。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-19 DOI: 10.1080/17576180.2025.2518725
Lee Goodwin, Jörg Faber, Kristina H Holmberg, Stuart McDougall, John Meijer, Debora Tagliacozzi, Stephen White, Philip Timmerman
{"title":"Whole blood stability in bioanalytical method validation: updated recommendations from the European Bioanalysis Forum.","authors":"Lee Goodwin, Jörg Faber, Kristina H Holmberg, Stuart McDougall, John Meijer, Debora Tagliacozzi, Stephen White, Philip Timmerman","doi":"10.1080/17576180.2025.2518725","DOIUrl":"10.1080/17576180.2025.2518725","url":null,"abstract":"<p><p>This paper discusses the updated recommendations from the European Bioanalysis Forum on whole blood stability testing in bioanalytical method validation. The recommendations are based on EBF community feedback on the ICH M10 guidelines and associated training materials. The ICH M10 guidelines highlight the importance of assessing analyte stability throughout the lifecycle of the sample, including in whole blood, immediately after collection, to ensure that the analyte concentration in the tested sample accurately reflects the concentration at the time of collection. Aspects considered in these recommendations are the definition of fresh blood, equilibration times, assay type and how the experiments can be conducted to align with the 3Rs principles.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"767-768"},"PeriodicalIF":1.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332408","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
Quantitation of BCAA and BCKA in plasma and patient-centric dried blood microsamples in a clinical setting. 血浆和以患者为中心的干血微样本中BCAA和BCKA的定量研究
IF 1.9 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-10 DOI: 10.1080/17576180.2025.2515008
Brendan Tierney, Pirinka Georgiev Tuttle, F Isik Karahanoglu, Christian Russel Reyes, Yalei Chen, Matthew Blatnik, Savon Vigil, Matthew Ziegenfelder, Mar Santamaria, Denise E Chou, Bunmi Williams, Anna Gao, Briana Peterson, Bhavna Adhin, Xuemei Cai
{"title":"Quantitation of BCAA and BCKA in plasma and patient-centric dried blood microsamples in a clinical setting.","authors":"Brendan Tierney, Pirinka Georgiev Tuttle, F Isik Karahanoglu, Christian Russel Reyes, Yalei Chen, Matthew Blatnik, Savon Vigil, Matthew Ziegenfelder, Mar Santamaria, Denise E Chou, Bunmi Williams, Anna Gao, Briana Peterson, Bhavna Adhin, Xuemei Cai","doi":"10.1080/17576180.2025.2515008","DOIUrl":"10.1080/17576180.2025.2515008","url":null,"abstract":"<p><strong>Aim: </strong>This study assessed the agreement and bias of three dried blood patient-centric microsampling (PCS) devices (paper DBS, Mitra, and Tasso-M20) for the quantitation of branched chain amino acids (BCAAs) and ketoacids (BCKAs) compared to venous plasma samples.</p><p><strong>Materials & methods: </strong>Concentrations of BCAAs and BCKAs were measured in samples from generally healthy participants with a validated assay for venous plasma adapted for use with dried blood from the PCS devices. Participants were also asked to respond to a device usability questionnaire about their experience with the devices.</p><p><strong>Results: </strong>The correlations between BCAA/BCKA concentration values in PCS devices vs venipuncture samples were strong to excellent for all six analytes, across all three PCS devices. The surrogate analyte approach facilitated method transfer from plasma to dried blood microsampling devices. Overall, participants reported that they enjoyed using the devices compared to traditional venipuncture and would be willing to use them again, on their own at-home.</p><p><strong>Conclusion: </strong>These study results demonstrate the feasibility of quantitating BCAAs and BCKAs reliably with PCS devices, with high acceptability from study participants.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"707-723"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265185","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
Simultaneous estimation of donepezil and quercetin using ultra high performance liquid chromatography: pharmaceutical and pharmacokinetic applications in Alzheimer's disease. 用超高效液相色谱法同时测定多奈哌齐和槲皮素:阿尔茨海默病的药学和药代动力学应用。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-17 DOI: 10.1080/17576180.2025.2518044
Shourya Tripathi, Rafquat Rana, Jvus Chakradhar, Keerti Mishra, Srishty Jaiswal, Mitali Sethi, Amrendra Kumar Tiwari, Manish Kumar Chourasia
{"title":"Simultaneous estimation of donepezil and quercetin using ultra high performance liquid chromatography: pharmaceutical and pharmacokinetic applications in Alzheimer's disease.","authors":"Shourya Tripathi, Rafquat Rana, Jvus Chakradhar, Keerti Mishra, Srishty Jaiswal, Mitali Sethi, Amrendra Kumar Tiwari, Manish Kumar Chourasia","doi":"10.1080/17576180.2025.2518044","DOIUrl":"10.1080/17576180.2025.2518044","url":null,"abstract":"<p><strong>Background: </strong>Alzheimer's disease (AD) affects over 55.2 million individuals globally with current treatment modalities only providing symptomatic relief. This highlights the importance of combination therapies which target multiple pathways simultaneously. Donepezil (DNP), an acetylcholinesterase inhibitor, when combined with Quercetin (QCT), a polyhydroxy flavonoid with neuroprotective properties, might alter progression. However, simultaneous estimation of DNP and QCT for concurrent delivery, calls for robust analytical method that can simultaneously estimate both drugs.</p><p><strong>Research design and methods: </strong>A simple, robust, and cost-friendly UHPLC method for simultaneous estimation of DNP and QCT was developed. The analytes were resolved on C18 column (Kromasil C18, 4.6 × 250 mm), with acetonitrile and 0.1% diethyl amine buffer, adjusted to pH 3.5 with glacial acetic acid as mobile phase in ratio 50:50 v/v at 0.6 mL/min, at column oven temperature 40°C in total analysis run time of 10 min.</p><p><strong>Results: </strong>DNP and QCT were quantified by PDA detector at 268 nm and 370 nm, respectively. The developed method was found to be linear, accurate, precise, specific, and robust as per ICH guidelines.</p><p><strong>Conclusion: </strong>The developed and validated method efficiently quantified DNP and QCT co-loaded inside liposomes estimating their entrapment efficiency, loading efficiency, and in vivo plasma kinetics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"747-757"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309494","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
Detection of Streptococcus anginosus in fecal samples using PCR-CRISPR /Cas12a system. 利用PCR-CRISPR /Cas12a系统检测粪便标本中的血管链球菌。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2025-06-01 Epub Date: 2025-06-12 DOI: 10.1080/17576180.2025.2518042
Yan Zheng, BiXia Liu, QianFei Zuo, Fei Deng, ChunHui Lan
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