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Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children. 体积微样品中六种抗生素的生物分析:一种用于危重儿童精确给药的新工具。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0171
John Takyi-Williams, Abbie D Leino, Ruiting Li, Kevin J Downes, Athena F Zuppa, Amanda Bwint, Bo Wen, Duxin Sun, Marc H Scheetz, Manjunath P Pai
{"title":"Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children.","authors":"John Takyi-Williams, Abbie D Leino, Ruiting Li, Kevin J Downes, Athena F Zuppa, Amanda Bwint, Bo Wen, Duxin Sun, Marc H Scheetz, Manjunath P Pai","doi":"10.4155/bio-2023-0171","DOIUrl":"10.4155/bio-2023-0171","url":null,"abstract":"<p><p><b>Background:</b> Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present the bioanalytical method development for the simultaneous quantification of ampicillin, cefepime, ceftriaxone, meropenem, piperacillin, tazobactam, and vancomycin from VAMS. <b>Methods & results:</b> Optimal extraction, chromatographic, and mass spectrometry conditions were identified. Maximum extraction recoveries included 100 μl of water for rehydration and methanol for protein precipitation. Chromatographic separation used Phenomenex Kinetex<sup>™</sup> Polar C18 column with a mobile phase comprising water/acetonitrile with formic acid and was fully validated. Hematocrit effects were only observed for vancomycin. Samples were stable for 90 days at -80°C except for meropenem, which was stable for 60 days. <b>Conclusion:</b> Multiple antibiotics can be assayed from a single VAMS sample to facilitate pharmacokinetic/pharmacodynamic studies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10718164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290193","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
Challenges and current advances in the methodology of thyroglobulin measurements. 甲状腺球蛋白测量方法的挑战和当前进展。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0149
Ilona Đorić, Sonja Šelemetjev
{"title":"Challenges and current advances in the methodology of thyroglobulin measurements.","authors":"Ilona Đorić, Sonja Šelemetjev","doi":"10.4155/bio-2023-0149","DOIUrl":"10.4155/bio-2023-0149","url":null,"abstract":"<p><p>Thyroglobulin (Tg) is a large protein secreted exclusively by the thyroid gland. In a clinical setting, it is measured for the purpose of follow-up of thyroidectomy patients. However, Tg measurements are often impeded by the presence of Tg autoantibodies and/or heterophylic antibodies that interfere with most measuring platforms. This presents a global problem in thyroid cancer patients who need to be postoperatively monitored for recurrent or residual disease. Therefore, in this paper we offer an overview of the existing methodologies and alternative approaches for Tg measurements that are a focus of research worldwide. These include Tg mRNA measurements, exosomal Tg detection, the use of alternative analytes (liquid biopsies) and the development of new approaches for preanalytical sample treatment.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290194","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
Free hemoglobin determination at patients' bedside to evaluate hemolysis. 床边检测游离血红蛋白评价溶血情况。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-12-05 DOI: 10.4155/bio-2023-0116
Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol
{"title":"Free hemoglobin determination at patients' bedside to evaluate hemolysis.","authors":"Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol","doi":"10.4155/bio-2023-0116","DOIUrl":"10.4155/bio-2023-0116","url":null,"abstract":"<p><p><b>Background:</b> The authors report the relevance of using a point of care test (Helge<sup>®</sup>) for free hemoglobin determination and concordance of the values the with Cobas<sup>®</sup> 8000 and spectrophotometer methods. <b>Results:</b> The within-run of the point of care test was <3%. Good correlations among the three methods were observed and an acceptable concordance for hemolysis index values from 50 mg/dl. An excellent agreement between the Cobas 8000 and the spectrophotometer was found. <b>Conclusion:</b> Automated methods represent methods of choice for free hemoglobin determination. An advantage of the Helge system is that it can be applied to samples experiencing a delay in evaluation due to the long distance between the collection site and the central laboratory. Another advantage is its use at the bedside, in the monitoring of extracorporeal membrane oxygenation patients.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138481789","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
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners - part 2. 生物分析访谈：与2023年里德奖学金获得者对话--第二部分。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-26 DOI: 10.4155/bio-2024-0051
Olga Begou, Artemis Lioupi, Georgina Page, Shwan Ahmed, Svenja Stiltz, Rebecca Dowell, Jack Lodge
{"title":"An interview with <i>Bioanalysis</i>: speaking with the 2023 Reid bursary award winners - part 2.","authors":"Olga Begou, Artemis Lioupi, Georgina Page, Shwan Ahmed, Svenja Stiltz, Rebecca Dowell, Jack Lodge","doi":"10.4155/bio-2024-0051","DOIUrl":"10.4155/bio-2024-0051","url":null,"abstract":"<p><p>The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) between 4 and 7 September 2023 and hosted approximately 100 delegates, the majority of whom were attending the event for their first time.REID encourages early-career researchers to present their work and have a bursary program to help provide them support. At the 2023 event, REID welcomed 15 bursary winners to provide them with the opportunity to participate in their first international meeting, network with their peers and make their first oral, or poster presentation. The bursary winners also had the opportunity to interview with the <i>Bioanalysis</i> journal and their responses to the interview questions are transcribed below in this second part of two.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288094","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
An LC-MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma. 用 LC-MS/MS 方法测定人体血浆中的溴化酶抑制剂 ZEN-3694 及其代谢物 ZEN-3791。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-18 DOI: 10.4155/bio-2023-0252
Ye Feng, Haider Mahdi, Richard Piekarz, Jan H Beumer, Timothy W Synold
{"title":"An LC-MS/MS method for determination of the bromodomain inhibitor ZEN-3694 and its metabolite ZEN-3791 in human plasma.","authors":"Ye Feng, Haider Mahdi, Richard Piekarz, Jan H Beumer, Timothy W Synold","doi":"10.4155/bio-2023-0252","DOIUrl":"10.4155/bio-2023-0252","url":null,"abstract":"<p><p>We have developed and validated a novel LC-MS/MS method for the simultaneous quantification of ZEN-3694 and its active metabolite ZEN-3791 in human plasma after protein precipitation. Stable isotope-labeled versions were used as internal standards. Chromatographic separation was achieved on a Kinetex C18 column using 0.1% formic acid in H<sub>2</sub>O and 0.1% formic acid in MeOH as mobile phases. Detection was performed via positive electrospray ionization mode with multiple reaction monitoring. The assay exhibited linearity in the concentration range of 5-5000 ng/ml for both analytes. Intra- and inter-assay precision and accuracy were within ±11%. ZEN-3694 and ZEN-3791 recoveries were between 93 and 105%. This LC-MS/MS assay is an essential tool to study ZEN-3694 in an ongoing clinical trial (NCT04840589).</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216518/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142666","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 challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum. 在生物分析实验室实施良好临床实践的挑战：欧洲生物分析论坛的讨论文件。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-26 DOI: 10.4155/bio-2024-0055
Philip Timmerman, Tsvetelina Ivanova, Cecilia Arfvidsson, Matthew Barfield, Floris Bove, Lea Dalby Brown, Jo Goodman, Stuart McDougall, Lee Monk, Steve White
{"title":"The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum.","authors":"Philip Timmerman, Tsvetelina Ivanova, Cecilia Arfvidsson, Matthew Barfield, Floris Bove, Lea Dalby Brown, Jo Goodman, Stuart McDougall, Lee Monk, Steve White","doi":"10.4155/bio-2024-0055","DOIUrl":"10.4155/bio-2024-0055","url":null,"abstract":"<p><p>This manuscript reports back from the discussion in the European Bioanalysis Forum community on the challenges observed when implementing Good Clinical Practices in the bioanalytical laboratory. It is not intended to challenge any regulatory requirements but to open a discussion on where the bioanalytical community sees ambiguities on implementing Good Clinical Practices or areas where expectations are either felt not being owned by Bioanalysis or where Good Clinical Practices requirements are at risk of getting contaminated with requirements originating from Good Laboratory Practices. In addition to this, the discussions focused on three additional main challenges: the informed consent withdrawal, expedited reporting of unexpected results and the risk-based approach to quality management, The European Bioanalysis Forum community is continuing discussions, but already this manuscript should help to appreciate the challenges and to try and resolve them, involving all stakeholders.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11389731/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288098","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
Development and validation of bioanalytical methods to support clinical study of disitamab vedotin. 开发和验证生物分析方法，以支持迪西他单抗维多汀的临床研究。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-26 DOI: 10.4155/bio-2023-0230
Baiyang Wu, Qiaoning Li, Ling Wang, Fang Chen, Jing Jiang
{"title":"Development and validation of bioanalytical methods to support clinical study of disitamab vedotin.","authors":"Baiyang Wu, Qiaoning Li, Ling Wang, Fang Chen, Jing Jiang","doi":"10.4155/bio-2023-0230","DOIUrl":"10.4155/bio-2023-0230","url":null,"abstract":"<p><p>Disitamab vedotin (RC48), a humanized anti-HER2 antibody conjugated with monomethyl auristatin E (MMAE), is the first antibody-drug conjugate in China with an approved biological license application. A bioanalytical method was established for three analytes (total antibody, conjugate antibody and free payload) to help characterize their pharmacokinetic behavior in clinical settings. The bioanalytical methods were validated according to M10 guidance. Electrochemiluminescence assay methods were used for the quantitative measurement of total antibody and conjugated antibody in human serum. A LC-MS/MS method was used to quantify the concentration of MMAE in human serum. The method had high specificity and sensitivity with a quantitative range of 19.531-1250.000 ng/ml (total antibody), 39.063-5000.000 ng/ml (conjugated antibody) and 0.04-10.0 ng/ml (MMAE), respectively.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140288095","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
In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method. 通过经过验证的稳定性指示高效液相色谱法测定约旦西地那非仿制药的体外溶出度等效性。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-18 DOI: 10.4155/bio-2023-0257
Hamdi Nsairat, Ali Al-Samydai, Mohamed El-Tanani, Ashok K Shakya, Somaya Ahmad, Shorouq Alsotari, Walhan Alshaer, Ammar Shanneir, Munib M Saket, Tawfiq A Arafat
{"title":"<i>In vitro</i> dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method.","authors":"Hamdi Nsairat, Ali Al-Samydai, Mohamed El-Tanani, Ashok K Shakya, Somaya Ahmad, Shorouq Alsotari, Walhan Alshaer, Ammar Shanneir, Munib M Saket, Tawfiq A Arafat","doi":"10.4155/bio-2023-0257","DOIUrl":"10.4155/bio-2023-0257","url":null,"abstract":"<p><p>This study was conducted to compare dissolution profiles of four Jordanian registered sildenafil (SDF) products to the originator. Dissolution samples were analyzed utilizing a validated and stability-indicating HPLC method in human plasma. Validation was performed for specificity, linearity, limit of detection, lower limit of quantification, precision, trueness and stability. SDF was extracted from plasma samples using liquid-liquid extraction. The analysis was performed utilizing isocratic elution on C18 column with 1.0 ml/min flow rate. The regression value was ∼0.999 over 3 days with drug recovery between 86.6 to 89.8%with 10 ng/ml lower limit of quantitation. This method displayed a good selectivity of SDF with improved stability under various conditions. The method was used for SDF quantification in dissolution medium. Similarity factors for local products varied according to the used mediums, but all SDF local products passed the dissolution <i>in vitro</i> test since all of them showed a released of >85% after 60 min at the dissolution mediums.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142665","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 fusion of microfluidics and artificial intelligence: a novel alliance for medical advancements. 微流控技术与人工智能的融合：医学进步的新联盟。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-07-09 DOI: 10.1080/17576180.2024.2365528
Priyanka A Shah, Pranav S Shrivastav, Manjunath Ghate, Vishwajit Chavda
{"title":"The fusion of microfluidics and artificial intelligence: a novel alliance for medical advancements.","authors":"Priyanka A Shah, Pranav S Shrivastav, Manjunath Ghate, Vishwajit Chavda","doi":"10.1080/17576180.2024.2365528","DOIUrl":"10.1080/17576180.2024.2365528","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11485972/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141557902","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
Quantification of osilodrostat in horse urine using LC/ESI-HRMS to establish an elimination profile for doping control. 利用 LC/ESI-HRMS 对马尿液中的奥司洛司他（osilodrostat）进行定量，以建立兴奋剂控制的消除曲线。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-09-05 DOI: 10.1080/17576180.2024.2385848
Hideaki Ishii, Ryo Shigematsu, Shunsuke Takemoto, Yuhiro Ishikawa, Fumiaki Mizobe, Motoi Nomura, Daisuke Arima, Hirokazu Kunii, Reiko Yuasa, Takashi Yamanaka, Sohei Tanabe, Shun-Ichi Nagata, Masayuki Yamada, Gary Ngai-Wa Leung
{"title":"Quantification of osilodrostat in horse urine using LC/ESI-HRMS to establish an elimination profile for doping control.","authors":"Hideaki Ishii, Ryo Shigematsu, Shunsuke Takemoto, Yuhiro Ishikawa, Fumiaki Mizobe, Motoi Nomura, Daisuke Arima, Hirokazu Kunii, Reiko Yuasa, Takashi Yamanaka, Sohei Tanabe, Shun-Ichi Nagata, Masayuki Yamada, Gary Ngai-Wa Leung","doi":"10.1080/17576180.2024.2385848","DOIUrl":"10.1080/17576180.2024.2385848","url":null,"abstract":"<p><p><b>Aim:</b> The use of osilodrostat, developed as a medication for Cushing's disease but categorized as an anabolic agent, is banned in horses by both the International Federation of Horseracing Authorities and the Fédération Equestre Internationale. For doping control purposes, elimination profiles of hydrolyzed osilodrostat in horse urine were established and the detectability of free forms of osilodrostat and its major metabolite, mono-hydroxylated osilodrostat (M1c), was investigated.<b>Materials & methods:</b> Post-administration urine samples obtained from a gelding and three mares were analyzed to establish the elimination profiles of osilodrostat using a validated method involving efficient enzymatic hydrolysis followed by LC/ESI-HRMS analysis.<b>Results:</b> Applying the validated quantification method with an LLOQ of 0.05 ng/ml, hydrolyzed osilodrostat could be quantified in post-administration urine samples from 48 to 72 h post-administration; by contrast, both hydrolyzed osilodrostat and M1c were detected up to 2 weeks. In addition, confirmatory analysis identified the presence of hydrolyzed osilodrostat for up to 72 h post-administration.<b>Conclusion:</b> For doping control purposes, we recommend monitoring both hydrolyzed M1c and osilodrostat because of the greater detectability of M1c and the availability of a reference material of osilodrostat, which is essential for confirmatory analysis.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11486175/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131713","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
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