Bioanalysis最新文献_第2页

Microsampling techniques and patient-centric therapeutic drug monitoring of immunosuppressants.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-03-28 DOI: 10.1080/17576180.2025.2477976

Arkadiusz Kocur, Tomasz Pawiński

{"title":"Microsampling techniques and patient-centric therapeutic drug monitoring of immunosuppressants.","authors":"Arkadiusz Kocur, Tomasz Pawiński","doi":"10.1080/17576180.2025.2477976","DOIUrl":"10.1080/17576180.2025.2477976","url":null,"abstract":"Immunosuppressive pharmacotherapy after solid organ transplantation (SOT) requires therapeutic drug monitoring (TDM) for therapy individualization. The venous whole blood is still considered as routine matrix for monitoring immunosuppressive drug concentration. On the other hand, as an alternative, capillary blood collected using noninvasive sampling is convergent with a patient-centric approach. Despite their disadvantages regarding sample homogeneity and the hematocrit effect, well-known dried blood spot techniques have shown promising results. Volumetric absorptive microsampling (VAMS) and quantitative dried blood spot (qDBS) have successfully eliminated these unfavorable biased elements. Microsampling can be used in transplant recipients' care, mainly due to long-term therapy under control drug concentrations and the long distance between the place of the patient's residence and the diagnostic laboratory in the transplant center. The study aimed to discuss the clinical consequences of implementing microsampling techniques for TDM of immunosuppressants. Additionally, we have discussed the 'hot topics' in microsampling: home-based self-sampling, adherence to therapy monitoring, and drug concentration conversion to estimated traditional matrices. Finally, based on our experience and current practice, we propose best practices for microsampling implementation from bench to bedside. Microsampling techniques can potentially revolutionise immunosuppressive pharmacotherapy by enabling patient-centric individualisation in various subpopulations, significantly improving post-transplant care.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"413-427"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11959920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735603","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

Recent advances and future perspectives of biosensing technologies in anti-doping applications.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-03-24 DOI: 10.1080/17576180.2025.2481020

Ruixuan Li, Yudie Pan, Zixin Ye, Beidi Zhang, Gaozhi Ou

引用次数: 0

The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-03 DOI: 10.1080/17576180.2025.2461373

Johann Poetzl

引用次数: 0

Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-21 DOI: 10.1080/17576180.2025.2468596

Philip Timmerman, Steve White, Neil Adcock, Cecilia Arfvidsson, Matthew Barfield, Kyra Cowan, Luca Ferrari, Michaela Golob, Lee Goodwin, Richard Hughes, Tsvetelina Ivanova, Anna Laurén, Stuart McDougall, Robert Nelson, Nico van de Merbel, Tom Verhaeghe, Michael Wright

{"title":"Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.","authors":"Philip Timmerman, Steve White, Neil Adcock, Cecilia Arfvidsson, Matthew Barfield, Kyra Cowan, Luca Ferrari, Michaela Golob, Lee Goodwin, Richard Hughes, Tsvetelina Ivanova, Anna Laurén, Stuart McDougall, Robert Nelson, Nico van de Merbel, Tom Verhaeghe, Michael Wright","doi":"10.1080/17576180.2025.2468596","DOIUrl":"10.1080/17576180.2025.2468596","url":null,"abstract":"The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for in vitro assays such as plasma protein-binding studies. Even though the ICH M12 does not directly reference the ICH M10 Guideline on Bioanalytical Method Validation and Sample Analysis, its release prompted further discussions on assay validation requirements for these studies during the 17th European Bioanalysis Forum Open Symposium held in Barcelona, Spain, from 19 to 21 November 2024, where we advocated for a Context-of-Use driven approach over rigid adherence to ICH M10 standards. Context-of-Use driven validation ensures assays are tailored to the specific scientific and regulatory needs, optimizing resource allocation and innovation in drug development. This short opinion paper explores the potential and undesired implications of ICH M12 on bioanalytical validation practices, highlights the distinction between exploratory assays and assays having a clinical impact, and underscores the necessity for tailored validation strategies.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"379-382"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11959917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476090","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 methods in doping controls: a review.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-07 DOI: 10.1080/17576180.2025.2460951

Andreas Thomas, Katja Walpurgis, Nana Naumann, Thomas Piper, Mario Thevis

{"title":"Bioanalytical methods in doping controls: a review.","authors":"Andreas Thomas, Katja Walpurgis, Nana Naumann, Thomas Piper, Mario Thevis","doi":"10.1080/17576180.2025.2460951","DOIUrl":"10.1080/17576180.2025.2460951","url":null,"abstract":"The analytical and technological approaches employed in doping analysis are constantly reviewed and updated to allow for keeping pace with progresses in pharmaceutical and medicinal research and the therein inherent options of misuse as performance enhancing drugs or methods. Enormous changes, improvements, and developments have been achieved in recent years, particularly, but not exclusively, in the bioanalytical sector. Several of these new strategies are examined systematically in this review using examples from the World Anti-Doping Agency (WADA) list of banned substances and methods. The review includes, among others, the application of sophisticated new in-vitro models mimicking multi compartment models, investigation into new long-term metabolites for anabolic agents, the impact of a distinct gene mutation on the analysis of erythropoietin, studies on the development of new therapeutic protein-based drugs with myostatin inhibiting properties, methods applying the new molecular biological section used to uncover gene doping, and finally new approaches uncovering the prohibited use of autologous blood transfusion. All of these challenges and investigations support the ongoing progress in modern doping controls in the future and will help to fill the gap between the advance of cheating athletes and sport drug testing.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"359-370"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363534","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

Improved real-world UHPLC-MS/MS iohexol analysis; thawed samples, improved calibration curve, and additional matrices.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-03-01 Epub Date: 2025-02-07 DOI: 10.1080/17576180.2025.2462429

A Mireille A Wessels, Lenneke A T Junier, Daan Touw, Jasper Stevens

{"title":"Improved real-world UHPLC-MS/MS iohexol analysis; thawed samples, improved calibration curve, and additional matrices.","authors":"A Mireille A Wessels, Lenneke A T Junier, Daan Touw, Jasper Stevens","doi":"10.1080/17576180.2025.2462429","DOIUrl":"10.1080/17576180.2025.2462429","url":null,"abstract":"Background: Plasma clearance of iohexol is used to measure glomerular filtration rate, for which a UHPLC-MS/MS analytical method was previously developed. In real-world conditions, samples may be thawed on arrival and sampled in unvalidated matrices, prompting the need for an improved validation. We aim to improve the method for iohexol determination in plasma with enhanced stability testing, optimized calibration curves, and partial validation in additional matrices.Methods: Stability testing was conducted up to 9 weeks at room temperature, 4°C, 37°C, and at 37°C with daily two-hour exposure to 55°C. Quintuplicate QC samples were analyzed on 3 days, comparing results from eight-point and two-point calibration curves. Matrix comparison was performed on quintuplicate QC samples in serum, heparin plasma, urine, EDTA whole blood, and heparin whole blood.Results: The method improvements were all compliant with the requirements for bioanalytical methods issued by the US FDA and European Medicines Agency.Conclusion: Human EDTA plasma samples can be stored up to 9 weeks at room temperature, 4°C, 37°C, and 37°C with 55°C daily temperature spikes. The samples can be analyzed using a two-point calibration curve and are partial validated for serum-, heparin plasma-, urine-, EDTA whole blood-, and lithium whole blood iohexol samples.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"339-343"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363537","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

Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-02-01 Epub Date: 2025-01-30 DOI: 10.1080/17576180.2025.2458453

Saloumeh K Fischer

引用次数: 0

Recent advances in fluorescent gold nanocluster-based bioanalytical analysis and imaging in living cell.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-02-01 Epub Date: 2025-01-30 DOI: 10.1080/17576180.2025.2457853

Hanbing Ge, Longhui Zhan, Hao Chen, Ruibo Lv, Yanbo Wen, Mingxiang Chen, Fengniu Lu, Zhiqin Yuan

引用次数: 0

Simultaneous quantification of siRNA antisense and sense strands by hybrid liquid chromatography-mass spectrometry.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-02-01 Epub Date: 2025-01-31 DOI: 10.1080/17576180.2025.2457894

Karan Agrawal, Shaofei Ji, Wenying Jian

{"title":"Simultaneous quantification of siRNA antisense and sense strands by hybrid liquid chromatography-mass spectrometry.","authors":"Karan Agrawal, Shaofei Ji, Wenying Jian","doi":"10.1080/17576180.2025.2457894","DOIUrl":"10.1080/17576180.2025.2457894","url":null,"abstract":"Background: Most oligonucleotide bioanalytical assays currently only quantify the pharmacologically-active antisense strand, though there have been recent efforts to simultaneously quantify the sense strand using hybridization ELISA or solid phase extraction LC-MS. Hybrid LC-MS, which offers both high sensitivity and specificity unlike the currently used platforms, has not been applied to quantify both siRNA strands simultaneously.Materials & methods: A hybrid LC-MS assay utilizing LNA capture probes was developed and applied to quantify both strands of a 21-mer lipid-conjugated siRNA (SIR-3) using tandem mass spectrometry (MS/MS). A similar approach using high-resolution mass spectrometry (HRMS) was also evaluated.Results: The final LC-MS/MS method was capable of quantifying both strands of SIR-3 at concentrations between 0.600 and 1000 ng/mL in cynomolgus monkey tissue homogenates with acceptable accuracy and precision. The LC-HRMS assay demonstrated similar sensitivity and assay performance as the LC-MS/MS assay.Conclusions: Overall, this manuscript presents orthogonal methods to existing siRNA bioanalytical workflows that with high sensitivity and specificity can provide greater information about the concentration and biotransformation of an siRNA analyte.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"249-259"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063538","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

Artificial intelligence and blockchain in clinical trials: enhancing data governance efficiency, integrity, and transparency.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-02-01 Epub Date: 2025-01-23 DOI: 10.1080/17576180.2025.2452774

Víctor Leiva, Cecilia Castro

引用次数: 0