Bioanalysis最新文献

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Accelerating drug discovery with mass spectrometry-driven bioanalytical innovations and beyond. 加速药物发现与质谱驱动的生物分析创新和超越。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-05-01 Epub Date: 2026-06-21 DOI: 10.1080/17576180.2026.2687591
Joseph N Mwangi, Ryan Hill, Avery Runnebohm, Gregg Czerwieniec, Michael Berna
{"title":"Accelerating drug discovery with mass spectrometry-driven bioanalytical innovations and beyond.","authors":"Joseph N Mwangi, Ryan Hill, Avery Runnebohm, Gregg Czerwieniec, Michael Berna","doi":"10.1080/17576180.2026.2687591","DOIUrl":"10.1080/17576180.2026.2687591","url":null,"abstract":"<p><p>The emergence of structurally complex therapeutic modalities, including bispecific antibodies, antibody-drug conjugates, fusion proteins, incretins, radioligand therapeutics, antibody-oligonucleotide conjugates, and small interfering RNAs, demands advanced mass spectrometry workflows across the ADME pipeline. This forward-looking perspective examines the bioanalytical challenges these next-generation therapeutics present, from absorption and distribution through metabolism and elimination. Current MS platforms, LC-MS/MS, high-resolution MS, quantitative mass spectrometry imaging, and ICP-MS, while highly capable, present opportunities for sensitivity enhancement to fully characterize low-dose therapeutics through the elimination phase. To quantify this need, we developed a pharmacokinetic-driven prediction framework and applied it to FDA-approved complex therapeutics, demonstrating that enhanced sensitivity would enable comprehensive metabolite characterization, particularly during the elimination phase. We identify five convergent innovation priorities: (1) addressing modality complexity through integrated ADME workflows; (2) continued advancement of instrument sensitivity for low-dose therapeutics; (3) resolving biotransformation challenges through enhanced analytical resolution; (4) improving qMSI capabilities for therapeutic-level tissue detection; and (5) implementing AI/ML-driven automation for data complexity management. Rather than advocating for MS-only solutions, we recommend integration of mass spectrometric structural specificity with complementary high-throughput technologies; immunoassays, hybridization ELISA, qPCR, and element-specific detection, to enable comprehensive bioanalysis across all modalities, accelerating the path from discovery to development.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"619-638"},"PeriodicalIF":2.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13557602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148293175","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
Advances in the use of DNA aptamers for bioanalysis of antibody-based therapeutics. DNA适体在抗体治疗生物分析中的应用进展。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-05-01 Epub Date: 2026-06-11 DOI: 10.1080/17576180.2026.2687593
Kenichiro Todoroki
{"title":"Advances in the use of DNA aptamers for bioanalysis of antibody-based therapeutics.","authors":"Kenichiro Todoroki","doi":"10.1080/17576180.2026.2687593","DOIUrl":"10.1080/17576180.2026.2687593","url":null,"abstract":"<p><p>Nucleic acid aptamers are single-stranded oligonucleotides that fold into defined three-dimensional structures and bind molecular targets with high affinity and specificity. Because aptamers are sequence-defined, chemically synthesized reagents, they offer high purity, minimal lot-to-lot variability, and flexible functionalization, positioning them as practical alternatives or complements to antibody-based critical reagents in regulated bioanalysis. This review summarizes the current landscape of DNA aptamer-enabled bioanalysis for therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), with emphasis on three application areas: (i) ELISA-compatible ligand-binding assays, (ii) immunocapture workflows coupled to liquid chromatography-tandem mass spectrometry or LC-based measurements, and (iii) aptamer-based biosensors for bioanalysis and process analytics. This review highlights key considerations in aptamer acquisition (SELEX design, partitioning, and counter-selection to improve anti-idiotype selectivity) and illustrates representative assay configurations, including drug-to-antibody ratio-responsive formats for ADCs and ratiometric/electrochemical and fluorescence resonance energy transfer-based aptasensors for on-site monitoring. Finally, this review discusses future directions, notably coupling aptamer binding to nucleic acid amplification for ultra-sensitive quantification, and practical challenges, such as nuclease susceptibility, nonspecific interactions with serum proteins, and structure-dependent robustness that must be addressed under fit-for-purpose validation frameworks.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"649-662"},"PeriodicalIF":2.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13348937/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148215822","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
Quantifying diclofenac - proven in theory, problematic in practice. 定量双氯芬酸-理论上已被证实,但在实践中存在问题。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-21 DOI: 10.1080/17576180.2026.2677733
Sarah Hofmann, Eva Schöning, Peter Huber, Felix Leger, Heike Wiese
{"title":"Quantifying diclofenac - proven in theory, problematic in practice.","authors":"Sarah Hofmann, Eva Schöning, Peter Huber, Felix Leger, Heike Wiese","doi":"10.1080/17576180.2026.2677733","DOIUrl":"10.1080/17576180.2026.2677733","url":null,"abstract":"<p><strong>Aim: </strong>During clinical sample analysis unforeseen problems arose using a previously validated assay for the quantification of diclofenac in the concentration range from 0.0500 to 50.0 ng/mL. Here, we describe the troubleshooting process leading to the identification of the root cause and resulting changes in assay development strategy for robust supported liquid extraction (SLE)-based assays for clinical application.</p><p><strong>Methods: </strong>Individual steps of the sample preparation workflow and subsequent analysis with liquid chromatography and mass spectrometry (LCMS) were examined. Troubleshooting results were tested using stored validation samples and pooled clinical samples for confirmation.</p><p><strong>Results: </strong>The root cause for altered assay performance could be identified as the SLE plate batch effect attributable to variability in the sorbent material (diatomaceous earth). Reducing the sample loading volume applied to the SLE plates yielded purer extracts and consistent chromatographic performance. Quantitative recovery and signal consistency were restored after the modification.</p><p><strong>Conclusion: </strong>Assay robustness was improved by underloading SLE plates. After adjusting the method and re-validation, clinical samples were successfully analyzed. The internal method development strategy was adjusted to avoid full capacity loading of SLE plate with natural sorbents.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"441-446"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147986323","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 developments in analytical techniques for monitoring anabolic-androgenic steroids in biological and environmental matrices: challenges and future opportunities. 监测生物和环境基质中合成代谢雄激素类固醇分析技术的最新进展:挑战和未来机遇。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-27 DOI: 10.1080/17576180.2026.2676685
Nouf M Alourfi
{"title":"Recent developments in analytical techniques for monitoring anabolic-androgenic steroids in biological and environmental matrices: challenges and future opportunities.","authors":"Nouf M Alourfi","doi":"10.1080/17576180.2026.2676685","DOIUrl":"10.1080/17576180.2026.2676685","url":null,"abstract":"<p><p>Anabolic-androgenic steroids (AAS) are widely used in clinical practice but are also frequently misused, necessitating reliable analytical methods for their detection in biological and environmental matrices. This review summarizes recent developments in analytical techniques for AAS determination between 2011 and 2024, with emphasis on chromatographic and mass spectrometric approaches. Relevant literature was identified through searches of major scientific databases, including Scopus, Web of Science, and PubMed, using keywords related to anabolic-androgenic steroids and analytical detection methods; studies were selected based on relevance to methodological advances. Gas chromatography-mass spectrometry (GC-MS) remains a robust platform, with high-resolution GC-HRMS enhancing selectivity and retrospective analysis capabilities. Liquid chromatography-mass spectrometry (LC-MS/MS) provides high sensitivity and throughput for targeted quantification, while LC-HRMS enables broader screening through suspect and non-targeted approaches. Advances in sample preparation, including microextraction and automated workflows, have improved analytical efficiency and reduced matrix effects. Emerging platforms such as ion mobility spectrometry and ambient ionization methods offer rapid screening but remain complementary to established techniques. Overall, modern AAS analysis reflects a shift toward integrated analytical strategies combining targeted and high-resolution approaches to address increasing analytical complexity and evolving regulatory demands.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"529-542"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148026419","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
Validation approach of an LC-MS/MS assay for ADA detection, applied to a Von Willebrand factor-targeted biotherapeutic. 应用于血管性血友病因子靶向生物治疗药物的LC-MS/MS检测ADA的验证方法
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-28 DOI: 10.1080/17576180.2026.2679064
Frank B Schalk, Kayla Shumate, Pruthvi Nagilla, Guinevere S M Lageveen-Kammeijer, Peter Horvatovich, Nico C van de Merbel
{"title":"Validation approach of an LC-MS/MS assay for ADA detection, applied to a Von Willebrand factor-targeted biotherapeutic.","authors":"Frank B Schalk, Kayla Shumate, Pruthvi Nagilla, Guinevere S M Lageveen-Kammeijer, Peter Horvatovich, Nico C van de Merbel","doi":"10.1080/17576180.2026.2679064","DOIUrl":"10.1080/17576180.2026.2679064","url":null,"abstract":"<p><strong>Background: </strong>The efficiency of ligand binding assay (LBA)-based immunogenicity assessment can be compromised by the presence of high concentrations of soluble pharmacological target. This is particularly challenging for therapies targeting highly abundant multimeric plasma proteins, such as Von Willebrand Factor (VWF).</p><p><strong>Method: </strong>We developed and validated a hybrid LBA-LC-MS/MS assay in which a VWF-directed monoclonal antibody is immobilized to selectively extract anti-drug antibodies (ADAs) from plasma. Nonspecific binding was minimized by immunopurification and the ADAs were digested using trypsin. Semi-quantitative LC-MS/MS analysis of signature peptides unique to seven ADA isotypes (IgG1-4, IgM, IgA, and IgE) was performed against isotype-specific reference standards.</p><p><strong>Results: </strong>The method validation was conducted in alignment with current regulatory expectations for immunogenicity assessment, addressing all critical performance characteristics, including cut-point determination, sensitivity, specificity, and selectivity as well as precision, reproducibility, and robustness. The validated assay was successfully implemented as the primary method for assessing immunogenicity in clinical trial samples.</p><p><strong>Conclusion: </strong>This study demonstrates that hybrid LBA-LC-MS/MS enables single tier isotype-specific immunogenicity assessment in the presence of extreme target concentrations. The approach provides a viable alternative to traditional LBA-based strategies and can serve as the primary technique for immunogenicity assessment for regulatory-compliant evaluation of ADA responses.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"479-491"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148040993","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
European bioanalysis forum recommendations for strengthening bioanalytical method transfer and validation through collaborative interactions. 欧洲生物分析论坛关于通过协作互动加强生物分析方法转移和验证的建议。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-24 DOI: 10.1080/17576180.2026.2668968
Lene Andersen, Fabian Gaertner, Sibel Ahmedova, Sharareh Edwards, Pernille Grue, Deborah McManus, Stuart McDougall, Gwenda Pynaert, Klaus Pusecker, Eginhard Schick, Lisa Striegel-Sam, Laurent Vermet, Matthew Barfield, Lee Goodwin, Iain Love, Magnus Knutsson, Philip Timmerman
{"title":"European bioanalysis forum recommendations for strengthening bioanalytical method transfer and validation through collaborative interactions.","authors":"Lene Andersen, Fabian Gaertner, Sibel Ahmedova, Sharareh Edwards, Pernille Grue, Deborah McManus, Stuart McDougall, Gwenda Pynaert, Klaus Pusecker, Eginhard Schick, Lisa Striegel-Sam, Laurent Vermet, Matthew Barfield, Lee Goodwin, Iain Love, Magnus Knutsson, Philip Timmerman","doi":"10.1080/17576180.2026.2668968","DOIUrl":"10.1080/17576180.2026.2668968","url":null,"abstract":"<p><p>Bioanalytical method transfer is a critical and often vulnerable step in drug development, yet many challenges arise not from technical limitations but from misalignment, communication gaps and loss of scientific context as work moves between organizations. The European Bioanalysis Forum conducted a multi-table Pharma/CRO workshop and community survey to identify the behaviors that most influence transfer success. The discussions revealed consistent themes: early SME engagement, shared understanding of scientific intent, proactive communication, joint risk management and a clear responsibility split. This paper summarizes these insights and provides practical, interaction-focused recommendations to strengthen collaboration across method development, transfer and validation. Rather than prescribing templates or checklists, the European Bioanalysis Forum outlines behaviors and principles that promote clarity, predictability and scientific convergence. Reliable method transfer emerges from partnership mind-set and deliberate interaction, not procedural formality.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"429-432"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148004337","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
Immunogenicity assays are biomarker assays: is the 3-tiered paradigm fit-for-purpose? An illustrative case study. 免疫原性分析是生物标志物分析:三层模式是否适合目的?一个说明性的案例研究。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-27 DOI: 10.1080/17576180.2026.2677736
Lauren F Stevenson
{"title":"Immunogenicity assays are biomarker assays: is the 3-tiered paradigm fit-for-purpose? An illustrative case study.","authors":"Lauren F Stevenson","doi":"10.1080/17576180.2026.2677736","DOIUrl":"10.1080/17576180.2026.2677736","url":null,"abstract":"<p><p>This perspective highlights challenges associated with implementation of the 3-tiered paradigm over the past two-plus decades. A case study is used to illustrate re-analysis of anti-drug antibody (ADA) data from a Phase 1 clinical study of a monoclonal antibody, applying a biomarker-oriented approach. Unlike traditional analyses that focus on \"positive\" responses defined by statistical cut points, this approach incorporates all data, including \"negative\" responses, to characterize complete response profiles.By leveraging signal-to-noise (S/N) and raw signal data from the screening tier, the analysis provides a more granular, contextualized view of immunogenicity. Placebo data further inform longitudinal variability within the study population. This approach demonstrably clarifies apparent baseline positivity, distinguishes true treatment-emergent responses, and reveals that some subjects classified as ADA-positive under the traditional paradigm reflect biological variability or low-level, clinically irrelevant responses.Continuous readouts such as S/N enhance interpretation relative to titers and enable earlier insight into response dynamics without requiring additional assay tiers. Collectively, these findings underscore limitations of the current paradigm, including potential inflation of incidence, loss of clinical context, and mischaracterization of program risk. A biomarker-based framework offers an opportunity to generate more informative immunogenicity data more efficiently, supporting improved decision-making and facilitating timely regulatory evaluation.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"503-516"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321876/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148026407","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
Method qualification of an electrochemiluminescence assay to quantitate anti-FcεR1α autoantibodies: a case study of an antibody-based biomarker. 电化学发光法定量测定抗fc ε r1α自身抗体的方法鉴定:以抗体为基础的生物标志物为例。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-19 DOI: 10.1080/17576180.2026.2674992
Matthew J Lawless, Nikki Chan, Kruti Patel, Sonika Mudiyala
{"title":"Method qualification of an electrochemiluminescence assay to quantitate anti-FcεR1α autoantibodies: a case study of an antibody-based biomarker.","authors":"Matthew J Lawless, Nikki Chan, Kruti Patel, Sonika Mudiyala","doi":"10.1080/17576180.2026.2674992","DOIUrl":"10.1080/17576180.2026.2674992","url":null,"abstract":"<p><p>Chronic spontaneous urticaria is a common immunological disease that affects over 1% of the population. Recently, the anti-FcεR1α autoantibody has been discovered as a prominent biomarker related to the disease. Therefore, there is a need for robust, qualified assays to characterize and measure anti-FcεR1α autoantibodies in human serum. However, biomarker assay qualification is a topic of discussion and can sometimes be left open to interpretation. Currently, there is little guidance or best practices outlined for the method qualification of autoantibodies. These molecules are typically endogenous and such assays fall somewhere between quantitative and qualitative.Herein, we develop an electrochemiluminescence assay for the detection of anti-FcεR1α autoantibodies and provide an outline of method qualification. Two assay formats are investigated with one being fully developed and optimized. Other considerations stemming from immunogenicity qualifications are also assessed, such as isotyping, cut-point, and a confirmatory assay.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"457-465"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147970028","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
Preclinical pharmacokinetics of novel MYDGF for human PK and dose prediction. 新型MYDGF用于人PK的临床前药代动力学及剂量预测。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-06-08 DOI: 10.1080/17576180.2026.2682870
Maria Myzithras, Wei Wei, Tammy Bigwarfe, Lin-Zhi Chen, Priyanka Gupta, Hua Li, Anton Pekcec
{"title":"Preclinical pharmacokinetics of novel MYDGF for human PK and dose prediction.","authors":"Maria Myzithras, Wei Wei, Tammy Bigwarfe, Lin-Zhi Chen, Priyanka Gupta, Hua Li, Anton Pekcec","doi":"10.1080/17576180.2026.2682870","DOIUrl":"10.1080/17576180.2026.2682870","url":null,"abstract":"<p><strong>Aim: </strong>This study aimed to characterize the pharmacokinetics (PK) of recombinant human myeloid-derived growth factor (hMYDGF), a 15.8 kDa novel therapeutic protein for cardiac repair after myocardial infarction, in various preclinical animal species (mouse, Yorkshire pig and cynomolgus monkey) to guide human PK and dose prediction.</p><p><strong>Methodology: </strong>A custom, specific, ultra-sensitive MSD assay was developed to accurately quantitate hMYDGF in plasma. Single-dose pharmacokinetic studies were conducted in mice, Yorkshire pigs, and cynomolgus monkeys, followed by bioanalytical assessment and comprehensive pharmacokinetic analysis. <i>In vitro</i> human serum stability was also assessed using a custom LC-MS/MS-based assay. Plasma time-concentration profiles were fitted to a two-compartment PK model, with allometric scaling used to predict human PK parameters.</p><p><strong>Results: </strong>Rapid plasma clearance of hMYDGF was observed across all species, consistent with renal elimination driven by its low molecular weight. Serum stability tests indicate that clearance was not caused by nonspecific proteolytic degradation.</p><p><strong>Conclusion: </strong>Pharmacokinetics were accurately characterized in all species, enabling allometric scaling and predicted human PK and efficacious dose. Simulations indicated that a single intravenous bolus of 0.42 mg/kg in humans would achieve plasma levels linked to preclinical efficacy, supporting MYDGF's potential as a protein replacement therapy for acute myocardial infarction.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"493-502"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148197224","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
Correction. 修正。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-04-28 DOI: 10.1080/17576180.2026.2664979
{"title":"Correction.","authors":"","doi":"10.1080/17576180.2026.2664979","DOIUrl":"10.1080/17576180.2026.2664979","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"545"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147760862","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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