Therapeutic Drug Monitoring最新文献

{"title":"Relationships Between Tacrolimus Exposure and Adverse Events in Renal Transplant Patients: The ExpoTac Study.","authors":"Caroline Monchaud, Antoine Humeau, Sabrina Crépin, Lama Kawsarani, Claire Villeneuve, Isabelle Etienne, Jean-Philippe Rerolle, Pierre Marquet","doi":"10.1097/FTD.0000000000001287","DOIUrl":"10.1097/FTD.0000000000001287","url":null,"abstract":"<p><strong>Abstract: </strong>In transplantation, the association of tacrolimus exposure with efficacy is better known than with adverse effects. The ExpoTac study explored the relationships between tacrolimus exposure and adverse events (AEs) in kidney transplant patients who benefited from at least 3 measurements of tacrolimus area under the curve (AUC) within 2 years of transplantation. The relationships between tacrolimus AUC, trough concentration C 0 , peak concentration C max , and AEs were explored using univariate analysis and Cox models in 386 patients (1281 sets of exposure biomarkers). Headaches and renal impairment potentially induced by tacrolimus were associated with significantly lower mean dose-standardized exposure biomarkers and a higher proportion of C max values above the median. Patients with tremor displayed significantly higher mean AUC 0-24 (343 ± 79 versus 308 ± 63 hours·mcg/L, P = 0.041). Cox analysis revealed a significant association between (1) the time to the first headache report and mean C max , mean AUC 0-24 , and the proportion of C max values above the median (hazard ratios [95% confidence interval] = 0.237 [0.007-0.538]; 7.499 [1.508-29.713]; 5.055 [1.577-17.137]) and (2) the time to first renal impairment report and the proportion of C 0 values above the median (0.401 [0.098-0.681]). Refining AUC, C max , and C 0 upper limits would help to refine tacrolimus therapeutic ranges and limit the risks of AEs after kidney transplantation.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"152-160"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142772641","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}

{"title":"A Narrative Review of Chromatographic Bioanalytical Methods for Quantifying Everolimus in Therapeutic Drug Monitoring Applications.","authors":"Julia O Nascimento, Edlaine R Costa, Rita Estrela, Fernanda L Moreira","doi":"10.1097/FTD.0000000000001273","DOIUrl":"10.1097/FTD.0000000000001273","url":null,"abstract":"<p><strong>Background: </strong>Methods for measuring drug levels in the body are crucial for improving therapeutic drug monitoring (TDM) and personalized medicine. In solid-organ transplants, TDM is essential for the management of immunosuppressive drugs to avoid toxicity and organ rejection. Everolimus is a commonly used immunosuppressant with a small range of safe doses; therefore, it is important to adjust the dose according to each patient's needs. Therefore, reliable methods are required to accurately measure everolimus levels. This study aims to conduct a comprehensive and updated narrative review of chromatographic bioanalytical methods for everolimus quantification.</p><p><strong>Methods: </strong>The authors searched for original research articles published between 2013 and 2023 in Scopus and PubMed and found 295 articles after removing duplicates. Based on their titles and summaries, 30 articles were selected for a detailed review and 25 articles were included in the final analysis.</p><p><strong>Results: </strong>Among the 25 studies, 16 used protein precipitation, mainly with methanol, to prepare the samples, 12 used high-performance liquid chromatography, 11 used ultra-performance liquid chromatography, and 2 used both. Almost all the studies (24 of 25) used tandem mass spectrometry for detection, whereas only 1 used ultraviolet.</p><p><strong>Conclusions: </strong>This comprehensive review of bioanalytical methods for measuring everolimus using chromatography is a useful resource for researchers developing bioanalytical methods for TDM applications. Future trends in everolimus measurement include achieving lower detection limits, owing to the trend of reducing drug doses in therapy by improving sample extraction techniques and using more sensitive methods.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"49-63"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508526","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}

{"title":"miRNAs, dd-cf-DNA, and Chemokines as Potential Noninvasive Biomarkers for the Assessment of Clinical Graft Evolution and Personalized Immunosuppression Requirement in Solid Organ Transplantation.","authors":"Olga Millán, Judit Julian, Mercè Brunet","doi":"10.1097/FTD.0000000000001276","DOIUrl":"10.1097/FTD.0000000000001276","url":null,"abstract":"<p><strong>Abstract: </strong>The use of noninvasive biomarkers may reduce the need for biopsy and guide immunosuppression adjustments during transplantation. The scientific community in solid organ transplantation currently considers that chemokines, T- and B-cell immunophenotypes, and gene expression, among other molecular biomarkers, have great potential as diagnostic and predictive biomarkers for graft evolution; however, in clinical practice, few valid early biomarkers have emerged. This review focuses on the most relevant scientific advances in this field in the last 5 years regarding the role of 3 biomarkers: miRNAs, chemokines, and ddcf-DNA, in both adult and pediatric populations. An update was provided on the scores based on the combination of these biomarkers. The most-featured articles were identified through a literature search of the PubMed database. This review provides a comprehensive analysis of the potential clinical applications of these biomarkers in the diagnosis and prediction of graft outcomes and discusses the reasons why none have been implemented in clinical practice to date. Translating these biomarkers into routine clinical practice and combining them with pharmacogenetics and pharmacokinetic monitoring is challenging; however, it is the key to present/future individualized immunosuppressive therapies. It is essential that they be shown to be applicable and robust in real-life patient conditions and properly evaluate their added value when combined with the standard-of-care factor monitoring for graft clinical assessment. Partnership strategies among scientists, academic institutions, consortia, including expert working groups and scientific societies, and pharmaceutical and/or biotechnology companies should promote the development of prospective, randomized, multicenter intervention studies for adequate clinical validation of these biomarkers and their monitoring frequency, and their commercialization to make them available to transplant physicians.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"77-97"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583616","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}

{"title":"Therapeutic Drug Monitoring of Immunosuppressive Drugs: A Field Constantly in Motion.","authors":"Maria Shipkova, Florian Lemaitre","doi":"10.1097/FTD.0000000000001286","DOIUrl":"https://doi.org/10.1097/FTD.0000000000001286","url":null,"abstract":"","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 1","pages":"1-3"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955382","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}

{"title":"Customizing Tacrolimus Dosing in Kidney Transplantation: Focus on Pharmacogenetics.","authors":"Nuria Lloberas, Anna Vidal-Alabró, Helena Colom","doi":"10.1097/FTD.0000000000001289","DOIUrl":"https://doi.org/10.1097/FTD.0000000000001289","url":null,"abstract":"<p><strong>Abstract: </strong>Different polymorphisms in genes encoding metabolizing enzymes and drug transporters have been associated with tacrolimus pharmacokinetics. In particular, studies on CYP3A4 and CYP3A5, and their combined cluster have demonstrated their significance in adjusting tacrolimus dosing to minimize under- and overexposure thereby increasing the proportion of patients who achieve tacrolimus therapeutic target. Many factors influence the pharmacokinetics of tacrolimus, contributing to inter-patient variability affecting individual dosing requirements. On the other hand, the growing use of population pharmacokinetic models in solid organ transplantation, including different tacrolimus formulations, has facilitated the integration of pharmacogenetic data and other variables into algorithms to easier implement the personalized dose adjustment in transplant centers. The future of personalized medicine in transplantation lies in implementing these models in clinical practice, with pharmacogenetics as a key factor to account for the high inter-patient variability in tacrolimus exposure. To date, three clinical trials have validated the clinical application of these approaches. The aim of this review is to provide an overview of the current studies regarding the different population pharmacokinetic including pharmacogenetics and those translated to the clinical practice for individualizing tacrolimus dose adjustment in kidney transplantation.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 1","pages":"141-151"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142954014","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}

{"title":"New Developments and Therapeutic Drug Monitoring Options in Costimulatory Blockade in Solid Organ Transplantation: A Systematic Critical Review.","authors":"Gretchen N de Graav, Suwasin Udomkarnjananun, Carla C Baan, Marlies E J Reinders, Joke I Roodnat, Brenda C M de Winter, Dennis A Hesselink","doi":"10.1097/FTD.0000000000001275","DOIUrl":"10.1097/FTD.0000000000001275","url":null,"abstract":"<p><strong>Purpose: </strong>In this review, the authors summarized the latest developments in costimulatory blockade to prevent rejection after solid organ transplantation (SOT) and discussed possibilities for future research and the need for therapeutic drug monitoring (TDM) of these agents.</p><p><strong>Methods: </strong>Studies about costimulatory blockers in SOT in humans or animal transplant models in the past decade (2014-2024) were systematically reviewed in PubMed, European Union clinical trials (EudraCT), and ClinicalTrials.gov .</p><p><strong>Results: </strong>Seventy-five registered clinical trials and 58 published articles were found on costimulation blockade of the CD28-CD80/86, CD40-CD40L, and OX40-OX40L pathways. Belatacept, an antagonist of the CD28-CD80/86 pathway, is the only approved costimulatory agent in SOT, hence accounting for most of the research. Other identified costimulatory blocking agents included abatacept and CD28 antagonists tegoprubart, dazodalibep, and TNX-1500. Although tegoprubart was unsuccessful in pancreas transplantation in nonhuman primates, trials in human kidney transplantation are underway. Dazodalibep trials faced recruitment challenges. TNX-1500 was unsuccessful in animal studies and is currently not pursued in humans. After discontinuation of iscalimab (CD40-CD154 pathway antagonist) in SOT, the alternatives, bleselumab and KPL404, showed promising results in kidney transplantation and cardiac xenotransplantation. Studies on secondary costimulatory pathway antagonists, such as OX40-OX40L, have only used animal models. Despite the low interindividual variability in pharmacokinetics (PK) in all studied agents, TDM could be useful for optimizing dosing in PK/pharmacodynamic (PD) studies.</p><p><strong>Conclusions: </strong>The routine use of costimulation blockade in SOT is hindered by problems in efficacy compared with the standard of care. Costimulatory inhibitors could be combined in a calcineurin inhibitor-free regimen. Future PK/pharmacodynamic studies in costimulatory agents and personalized medicine could warrant TDM of these agents.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"64-76"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682886","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}

{"title":"Examining Whole Blood, Total and Free Plasma Tacrolimus in Elderly Kidney Transplant Recipients.","authors":"Amelia R Cossart, Nicole M Isbel, Scott B Campbell, Brett McWhinney, Christine E Staatz","doi":"10.1097/FTD.0000000000001274","DOIUrl":"https://doi.org/10.1097/FTD.0000000000001274","url":null,"abstract":"<p><strong>Background: </strong>Therapeutic monitoring is routinely performed to ensure tacrolimus whole-blood concentrations fall within a predefined target. Despite this, patients still experience inefficacy and toxicity that could be related to variability in free (unbound) tacrolimus exposure. Therefore, the aim of this study was to compare tacrolimus-free plasma (C u ), total plasma (C p ), and whole-blood (C wb ) concentrations in adult kidney transplant recipients and to characterize tacrolimus disposition across different matrices.</p><p><strong>Methods: </strong>Twelve-hour concentration-time profiling was performed in 15 recipients, allowing simultaneous measurement of C u , C p , and C wb . Pharmacokinetic parameters were estimated using noncompartmental analysis. The relationship between C wb and C p were examined using a capacity-limited binding model, incorporating the hematocrit fraction ( fHCT ) to estimate maximum binding concentration ( Bmax ) and dissociation constant ( Kd ). The relationship between C p and C u was evaluated using a linear binding model to estimate the nonspecific binding parameter ( Nplasma ). Nonlinear regression analysis was used to obtain estimates of Bmax , Kd , and Nplasma .</p><p><strong>Results: </strong>A total of 195 paired C wb , C p , and C u values were collected. The median ratios of C wb :C p , C p :C u , and C wb :C u were 9:1, 20:1, and 138:1, respectively. Variability in free plasma exposure was large; free trough values ranged from 8 to 51 ng/L and free area-under-the-concentration-time-curve values ranged from 424 to 7160 ng·h/L. Median (range) estimates of Bmax , Kd , and Nplasma were 90.4 µg/L (22.4-752.5 µg/L), 2.36 µg/L (0-69.2 µg/L), and 0.05 (0.035-0.085), respectively. The interindividual variability (CV%) in binding parameters was considerable ( Bmax 117.2%; Nplasma 32.5%).</p><p><strong>Conclusions: </strong>Large variability was observed in tacrolimus-free plasma exposure and binding parameters. Future research to characterize the relationship between tacrolimus C u and patient outcomes may be of benefit.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 1","pages":"161-168"},"PeriodicalIF":2.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142962435","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}

{"title":"Real-world Plasma Exposure of Nirmatrelvir/Ritonavir in Chinese Hospitalized Patients With COVID-19: A Multicenter Retrospective Study.","authors":"Zhiyuan Ma, Mengru Bai, Shuying Shen, Junshan Zhou, Rong Dong, Jiangjun Zhang, Yayun Weng, Li Li, Yongchen Li, Dan Liu, Wei Yan, Nengming Lin, Jianmei Xia","doi":"10.1097/FTD.0000000000001305","DOIUrl":"https://doi.org/10.1097/FTD.0000000000001305","url":null,"abstract":"<p><strong>Background: </strong>Nirmatrelvir/ritonavir is licensed for the treatment of mild-to-moderate coronavirus disease (COVID-19) in patients at an increased risk of progression to severe disease. However, data on the real-world plasma exposure to nirmatrelvir/ritonavir remain limited, particularly in Chinese patients. This study aimed to assess the nirmatrelvir/ritonavir trough concentration (Ctrough) and identify its critical factors in hospitalized Chinese patients treated with nirmatrelvir/ritonavir 300 mg/100 mg twice daily over a 5-day course.</p><p><strong>Methods: </strong>A high-performance liquid chromatography-tandem mass spectrometry assay was developed and validated to measure the nirmatrelvir/ritonavir Ctrough. Correlation analyses were performed to identify the variables influencing nirmatrelvir/ritonavir Ctrough.</p><p><strong>Results: </strong>Among the 110 patients, 100% had plasma concentrations above the antiviral in vitro 90% effective concentration. The median Ctrough of nirmatrelvir was 4.55 mcg/mL (15.6× 90% effective concentration), ranging from 0.65 to 12.44 mcg/mL. Nirmatrelvir Ctrough in normal and mild renal impairment cohorts were comparable (4.09 ± 1.97 mcg/mL and 4.57 ± 2.21 mcg/mL) but significantly increased in the moderate renal impairment cohort (6.41 ± 2.31 mcg/mL). Sex, age, and obesity were not significantly associated with nirmatrelvir exposure.</p><p><strong>Conclusions: </strong>Nirmatrelvir Ctrough was high in Chinese patients with COVID-19, and therapeutic drug monitoring should not be routinely recommended, except in patients with renal impairment.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068080","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}

{"title":"Comparative Analysis of 2 Commercially Available Assays for Therapeutic Drug Monitoring of Infliximab and Adalimumab.","authors":"Juan López Pérez, Mercedes Inda-Landaluce, Mercedes Nocito-Colón, Luis Martínez-Lostao","doi":"10.1097/FTD.0000000000001295","DOIUrl":"https://doi.org/10.1097/FTD.0000000000001295","url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor is a crucial proinflammatory cytokine in immune-mediated diseases. Tumor necrosis factor inhibitors (TNFi), such as infliximab and adalimumab, effectively treat rheumatological and digestive disorders. However, challenges such as primary nonresponse, secondary treatment failure, or adverse reactions limit their efficacy. Monitoring TNFi levels is essential for optimizing treatment and improving outcomes. An enzyme-linked immunosorbent assay (ELISA; Promonitor) was compared with 2 commercially available methods for quantifying infliximab and adalimumab levels: the chemiluminescence assay (i-Track10) and fluorescence assay (Afias-10).</p><p><strong>Methods: </strong>Serum samples from 166 patients with inflammatory bowel disease were analyzed. Drug levels were measured using i-Track10, Afias-10, and Promonitor. Spearman's correlation analysis, Bland-Altman analysis, analysis of differences, Passing-Bablok regression, and Cohen kappa for agreement assessment were used for statistical analysis.</p><p><strong>Results: </strong>Strong correlations were observed between Promonitor and Afias-10 for infliximab (rs = 0.982) and adalimumab (rs = 0.972), and with i-Track10 (rs = 0.935 for infliximab, rs = 0.947 for adalimumab). However, significant differences indicated noninterchangeability with ELISA. Passing-Bablok regression showed systematic and proportional biases. Cohen kappa exhibited higher concordance with Afias-10 for therapeutic ranges (κ = 0.962 for infliximab, κ = 0.849 for adalimumab) compared with i-Track10.</p><p><strong>Conclusions: </strong>Afias-10 and i-Track10 are suitable for TNFi monitoring but are not interchangeable with ELISA. Consistent assay methods should be used for patient monitoring to ensure accuracy and reliability.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034228","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}

{"title":"An Approach for Improving the Detection and Quantitation of Buprenorphine and Its Metabolites in Maternal and Neonatal Hair.","authors":"Osama Y Alshogran, Wenchen Zhao, Elizabeth E Krans, Steve Caritis, Imam H Shaik, Raman Venkataramanan","doi":"10.1097/FTD.0000000000001291","DOIUrl":"10.1097/FTD.0000000000001291","url":null,"abstract":"<p><strong>Background: </strong>Buprenorphine (BUP) use is prevalent in pregnant women with opioid use disorder (OUD). Drug monitoring during pregnancy is critical for optimizing dosing regimen and achieving the desired clinical outcomes. Hair can be used as a critical biological matrix for monitoring long-term exposure to drugs. The aim of this study was to optimize the methodology used to quantify BUP and its metabolites in hair samples.</p><p><strong>Methods: </strong>Conditions for hair sample processing (ie, hair washing, incubation temperature, and extraction time) were optimized to maximize extraction recovery. The LC-MS/MS strategy employed here used 4 deuterated internal standards for quantifying BUP and its major metabolites [norbuprenorphine (NBUP), buprenorphine glucuronide (BUP-G), and norbuprenorphine-glucuronide (NBUP-G)] in human hair samples. The optimized conditions were used to measure BUP and its metabolites in hair samples of 5 women undergoing OUD treatment and their neonates.</p><p><strong>Results: </strong>Unwashed hair samples processed by shaking with acetonitrile for 24 hours at 37 °C showed higher BUP (36%) and NBUP (67%) recovery, compared with those processed by incubation at room temperature. The standard curves showed excellent linearity over 0.05-100 ng/mL for BUP and NBUP and 0.1-200 ng/mL for BUP-G and NBUP-G. The assay was partially validated for reproducibility and accuracy and was successfully used for measuring BUP and metabolites in aforementioned hair samples. BUP was identified in all hair samples, while BUP-G was not. BUP was the primary analyte in maternal hair (median: 38.3 pg/mg; 25-75 percentile: 17-152.4 pg/mg), while NBUP-G was predominant in neonatal hair (median: 28.6 pg/mg; 25%-75% percentile: 1.9-112.8 pg/mg).</p><p><strong>Conclusions: </strong>The methodology used for quantifying BUP and its metabolites in hair samples of maternal female patients and their neonates is simple, accurate, and reproducible. The developed method may be useful for measuring fetal exposure to BUP during gestation.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142819149","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}