发布求助
文献互助 智能选刊 最新文献

Bioanalysis最新文献

筛选
英文 中文
Bioanalysis of the Bicycle® toxin conjugate BT5528 and released monomethyl auristatin E via liquid chromatography-tandem mass spectrometry. 通过液相色谱-串联质谱法对自行车®毒素共轭物 BT5528 和释放的单甲基金丝桃素 E 进行生物分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI: 10.4155/bio-2023-0189
Joseph A Tweed, Fern Adams-Dam, Jane Allanson, Kevin Holmes, Ryan Senior, Hongmei Xu, Mengyao Li, Gavin Bennett, Phil Jeffrey
{"title":"Bioanalysis of the Bicycle<sup>®</sup> toxin conjugate BT5528 and released monomethyl auristatin E via liquid chromatography-tandem mass spectrometry.","authors":"Joseph A Tweed, Fern Adams-Dam, Jane Allanson, Kevin Holmes, Ryan Senior, Hongmei Xu, Mengyao Li, Gavin Bennett, Phil Jeffrey","doi":"10.4155/bio-2023-0189","DOIUrl":"10.4155/bio-2023-0189","url":null,"abstract":"<p><p><b>Background:</b> The Bicycle<sup>®</sup> toxin conjugate BT5528 is a novel peptide therapeutic conjugated to the cytotoxic agent monomethyl auristatin E (MMAE). A bioanalytical assay was developed to quantify BT5528 and unconjugated MMAE in human plasma. <b>Methodology:</b> BT5528 quantitation used a protein precipitation procedure followed by LC-MS/MS detection. Quantitation of MMAE required a selective offline and online solid-phase extraction with detection via LC-MS/MS. <b>Results:</b> BT5528 was quantified over the assay range of 5-2500 ng/ml and free MMAE was quantified over the assay range of 0.05-50 ng/ml. <b>Conclusion:</b> Bioanalytical methods were used in the bioanalysis of intact BT5528 and released MMAE, in a phase I/IIa clinical trial; to date, over 2000 human patient samples have been analyzed.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138796653","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
Lessons learned from regulatory submissions involving endogenous therapeutic analyte bioanalysis. 从涉及内源性治疗分析生物分析的监管申请中吸取的经验教训。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI: 10.4155/bio-2023-0209
Chongwoo Yu, Wenlei Jiang, Murali Matta, Rong Wang, Sam Haidar, Hyeonglim Seo
{"title":"Lessons learned from regulatory submissions involving endogenous therapeutic analyte bioanalysis.","authors":"Chongwoo Yu, Wenlei Jiang, Murali Matta, Rong Wang, Sam Haidar, Hyeonglim Seo","doi":"10.4155/bio-2023-0209","DOIUrl":"10.4155/bio-2023-0209","url":null,"abstract":"<p><p>Endogenous therapeutic analytes include hormones, neurotransmitters, vitamins, fatty acids and inorganic elements that are naturally present in the body because either the body produces them or they are present in the normal diet. The accurate measurement of endogenous therapeutic analytes poses a challenge when the administered exogenous therapeutic analyte and its endogenous counterpart cannot be distinguished. In this article, real case examples with endogenous therapeutic analyte bioanalysis during drug development in support of regulatory submissions are collected and presented. The article highlights common challenges encountered and lessons learned related to bioanalysis of endogenous therapeutic analytes and provides practical tips and strategies to consider from a regulatory perspective.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138796676","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
LC-MS/MS method for simultaneous estimation of raloxifene, cladrin in rat plasma: application in pharmacokinetic studies. 用 LC-MS/MS 方法同时估算大鼠血浆中的雷洛昔芬和克拉霉素：在药代动力学研究中的应用
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0206
Divya Chauhan, Shailesh Dadge, Pavan K Yadav, Nazneen Sultana, Arun Agarwal, Sachin Vishwakarma, Shivam Rathaur, Shubhi Yadav, Manish K Chourasia, Jiaur R Gayen
{"title":"LC-MS/MS method for simultaneous estimation of raloxifene, cladrin in rat plasma: application in pharmacokinetic studies.","authors":"Divya Chauhan, Shailesh Dadge, Pavan K Yadav, Nazneen Sultana, Arun Agarwal, Sachin Vishwakarma, Shivam Rathaur, Shubhi Yadav, Manish K Chourasia, Jiaur R Gayen","doi":"10.4155/bio-2023-0206","DOIUrl":"10.4155/bio-2023-0206","url":null,"abstract":"<p><p><b>Aim:</b> A newer LC-MS/MS method was developed and validated for the simultaneous quantification of raloxifene (RL) and cladrin (CL). <b>Methodology:</b> Both drugs were resolved in RP-18 (4.6 × 50 mm, 5 μ) Xbridge Shield column using acetonitrile and 0.1% aqueous solution of formic acid (FA) (70:30% v/v) as mobile phase by using biological matrices in female Sprague-Dawley rats using-MS/MS. <b>Results:</b> The developed method was found to be linear over the concentration ranges of 1-600 ng/ml, and lower limit of quantification was 1 ng/ml for RL and CL, respectively. Pharmacokinetic results of RL+CL showed C<sub>max</sub> = 4.23 ± 0.61, 26.97 ± 1.14 ng/ml, at T<sub>max</sub>(h) 5.5 ± 1.00 and 3.5 ± 1.00, respectively. <b>Conclusion:</b> Pharmacokinetic study results will be useful in the future for the combined delivery of RL and CL for osteoporosis treatment.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401632","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
Validation of Mitra® VAMS® as a blood collection technique for trace elements analysis using ICP-MS/MS. 使用 ICP-MS/MS 对 Mitra® VAMS® 作为痕量元素分析的血液采集技术进行验证。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0180
Anthony Breton, Ciprian Mihai Cirtiu, Cyril Muehlethaler, James Rudge, Normand Fleury
{"title":"Validation of Mitra<sup>®</sup> VAMS<sup>®</sup> as a blood collection technique for trace elements analysis using ICP-MS/MS.","authors":"Anthony Breton, Ciprian Mihai Cirtiu, Cyril Muehlethaler, James Rudge, Normand Fleury","doi":"10.4155/bio-2023-0180","DOIUrl":"10.4155/bio-2023-0180","url":null,"abstract":"<p><p><b>Background:</b> Clinical dosage of toxic and essential elements in blood is well established and the collection method is still by venipuncture. This method has drawbacks and is not suited for everyone. Volumetric absorptive microsampling (VAMS) has been shown to have advantages over venipuncture. <b>Materials & methods:</b> Using inductively coupled plasma tandem mass spectrometry, a method for quantifying elements in whole blood sampled on VAMS was developed/validated. Method's performance was assessed by comparison with whole blood results. <b>Results:</b> Validation and performance assessment tests tend to show that most of the targeted elements provides accurate and reproducible results comparing to a method of reference. <b>Conclusion:</b> Overall, VAMS presents good preliminary results to eventually become an alternative to venipuncture for blood sampling for some trace elements analysis purposes.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139471810","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
Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum. 在体外诊断医疗器械法规中找到我们的方向：欧洲生物分析论坛的讨论文件。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0262
Philip Timmerman, Anna Laurén, Robert Nelson, Matthew Barfield
{"title":"Finding our way in the <i>In Vitro</i> Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum.","authors":"Philip Timmerman, Anna Laurén, Robert Nelson, Matthew Barfield","doi":"10.4155/bio-2023-0262","DOIUrl":"10.4155/bio-2023-0262","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401631","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
Digital image colorimetry for determination of ethanol in exhaled breath condensate. 数字图像比色法测定呼出气体冷凝物中的乙醇含量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0147
Yasaman Sefid-Sefidehkhan, Maryam Khoshkam, Samineh Raha, Fariba Pourkarim, Abolghasem Jouyban, Maryam Khoubnasabjafari, Vahid Jouyban-Gharamaleki, Elaheh Rahimpour
{"title":"Digital image colorimetry for determination of ethanol in exhaled breath condensate.","authors":"Yasaman Sefid-Sefidehkhan, Maryam Khoshkam, Samineh Raha, Fariba Pourkarim, Abolghasem Jouyban, Maryam Khoubnasabjafari, Vahid Jouyban-Gharamaleki, Elaheh Rahimpour","doi":"10.4155/bio-2023-0147","DOIUrl":"10.4155/bio-2023-0147","url":null,"abstract":"<p><p><b>Aim:</b> This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. <b>Method:</b> This research presents a straightforward smartphone-based colorimetric sensor that efficiently measures ethanol levels in exhaled breath condensate (EBC) samples. The process involved changing the acidic dichromate color in an ethanolic solution, followed by image analysis. <b>Results:</b> The results showed that this method was able to estimate ethanol concentrations in the range of 300-1500 and 1600-8000 μg ml<sup>-1</sup> in EBC. <b>Conclusion:</b> This study was a follow-up study on the previous work published for the determination of ethanol in EBC samples and highlights the potential benefits of using digital images and smartphone applications for ethanol determination in biological samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139471800","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
Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid. 扩大检测范围，以适应血液和脑脊液中单克隆抗体的治疗定量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI: 10.4155/bio-2023-0179
Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer
{"title":"Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid.","authors":"Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer","doi":"10.4155/bio-2023-0179","DOIUrl":"10.4155/bio-2023-0179","url":null,"abstract":"<p><p>Antibody therapeutic levels in neurodegenerative diseases are often measured in both serum and cerebrospinal fluid (CSF). Due to 0.1% drug partition from serum to CSF and the higher sensitivity needs, usually two different assays are required. The different Gyrolab Bioaffy compact discs can extend the dynamic range of assays. Here, an assay was developed and adapted on two different Gyrolab Bioaffy compact discs (200 and 4000 nl) to achieve the required sensitivity and assay dynamic range needed for the measurement of drug in both serum and CSF. This was accomplished by using the same critical reagents with minimal assay development to transition from a serum to a CSF assay.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138796664","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
LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens. 对福尔马林固定石蜡包埋组织标本中的蛋白质生物标记物和蛋白质疗法进行液相色谱-质谱生物分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0210
Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng
{"title":"LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens.","authors":"Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng","doi":"10.4155/bio-2023-0210","DOIUrl":"10.4155/bio-2023-0210","url":null,"abstract":"<p><p>Formalin-fixed paraffin-embedded (FFPE) is a form of preservation and preparation for biopsy specimens. FFPE tissue specimens are readily available as part of oncology studies because they are often collected for disease diagnosis or confirmation. FFPE tissue specimens could be extremely useful for retrospective studies on protein biomarkers because the samples preserved in FFPE blocks could be stable for decades. However, LC-MS bioanalysis of FFPE tissues poses significant challenges. In this Perspective, we review the benefits and recent developments in LC-MS approach for targeted protein biomarker and protein therapeutic analysis using FFPE tissues and their clinical and translational applications. We believe that LC-MS bioanalysis of protein biomarkers in FFPE tissue specimens represents a great potential for its clinical applications.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139471805","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
WRIB Poster Awards winners 2023. 2023 年 WRIB 海报奖获奖者。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-25 DOI: 10.4155/bio-2024-0012
Jennifer Getz, Shannon McGrath, Gus Hui
{"title":"WRIB Poster Awards winners 2023.","authors":"Jennifer Getz, Shannon McGrath, Gus Hui","doi":"10.4155/bio-2024-0012","DOIUrl":"10.4155/bio-2024-0012","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139544846","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
Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography-tandem mass spectrometry. 利用液相色谱-串联质谱法对兔泪液基质中的莫西沙星和酮咯酸氨丁三醇进行眼部生物分析。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0233
Amol Chhatrapati Bisen, Rabi Sankar Bhatta
{"title":"Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography-tandem mass spectrometry.","authors":"Amol Chhatrapati Bisen, Rabi Sankar Bhatta","doi":"10.4155/bio-2023-0233","DOIUrl":"10.4155/bio-2023-0233","url":null,"abstract":"<p><p><b>Aim:</b> The fixed-dose combination of moxifloxacin (MOXI) and ketorolac tromethamine (KTR) is widely used for the treatment of bacterial keratitis. Thus, a new LC-MS/MS method was developed to determine MOXI and KTR in lacrimal fluid. <b>Methods:</b> Bioanalysis was performed using a Shimadzu 8050 LC-MS/MS in electrospray ionization-positive mode and the method was validated per US FDA guidelines. Isocratic separation was performed with a Waters Symmetry C<sub>18</sub> column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). <b>Results & conclusion:</b> An easy, quick and selective method was established and applied to assess the ocular pharmacokinetic profile of a commercially available formulation containing MOXI and KTR. Based on the pharmacokinetic data, this work describes pharmacokinetics-based dosage regimen calculations and their clinical significance.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139401633","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
首页 上一页 下一页 尾页
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：481959085
Book学术官方微信