Therapeutic Drug Monitoring最新文献

{"title":"Serum Lenvatinib Concentration Monitoring in a Patient With Thyroid Cancer Exhibiting Hand-Foot Syndrome.","authors":"Yusuke Watanabe, Kosuke Doki, Ikuo Sekine, Hisato Hara, Masato Homma","doi":"10.1097/FTD.0000000000001312","DOIUrl":"10.1097/FTD.0000000000001312","url":null,"abstract":"<p><strong>Background: </strong>Hand-foot syndrome (HFS) is a common adverse event associated with lenvatinib treatment. Lenvatinib dose adjustment using therapeutic drug monitoring may be beneficial in the management of HFS, as symptoms improve with dose reduction or treatment interruption. The serum lenvatinib levels were monitored in a patient with lenvatinib-induced HFS.</p><p><strong>Case presentation: </strong>A 74-year-old woman was administered lenvatinib (24 mg/d) for papillary thyroid cancer. Although lenvatinib was withheld several times owing to the occurrence of HFS, the severity of the HFS was controlled to within grade 1 by reducing the dose to 4 mg/d. The lenvatinib dose was subsequently increased to 8 mg/d owing to the progression of lung metastases, resulting in increased HFS severity. The association between serum lenvatinib levels and the severity of HFS was examined in this case: serum lenvatinib levels were higher in grade 2 HFS than in grade 1 HFS (median 42.1 vs. 22.5 ng/mL; P < 0.05).</p><p><strong>Conclusions: </strong>This case's findings suggest that serum lenvatinib concentrations are associated with the severity of lenvatinib-induced HFS and that there may be an overlap between drug concentrations, metastatic suppression, and the grade of HFS.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"323-325"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143528009","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":"Nifedipine May Be an Inhibitor of Clozapine Metabolism as Seen in 5 Patients: 2 From a US Double-Blind Study and 3 From a German Therapeutic Drug Monitoring Study.","authors":"Georgios Schoretsanitis, Ekkehard Haen, Hélène Verdoux, Michael Paulzen, Jose de Leon","doi":"10.1097/FTD.0000000000001277","DOIUrl":"10.1097/FTD.0000000000001277","url":null,"abstract":"<p><strong>Background: </strong>Clozapine is the only licensed antipsychotic for treatment-refractory schizophrenia. Therapeutic drug monitoring (TDM) refers to the measurement of clozapine concentration. Clozapine TDM can be used to optimize treatment, particularly by identifying pharmacokinetic interactions between clozapine and comedications.</p><p><strong>Methods: </strong>We identified 5 cases of patients with available clozapine concentrations who were concomitantly receiving nifedipine and clozapine. These cases were drawn from 2 independent datasets: 2 from a double-blind, randomized clinical trial in the United States and 3 from a German TDM naturalistic database. As an index of clozapine clearance, we used the trough-level concentration-to-dose (C/D) ratios to estimate the minimum therapeutic doses. To estimate dose-correction factors for nifedipine treatment, we included only clozapine concentrations at steady state. We divided the clozapine minimum therapeutic doses (MTD) from the on-condition by the off-nifedipine condition.</p><p><strong>Results: </strong>In 4 patients, the ratio of on/off nifedipine for MTD ranged between 0.58 and 0.82. Another patient had no data and had to be compared with published control data (female smoker of African ancestry), providing a correction factor of 0.52 after eliminating 5 concentrations contaminated by the development of obesity.</p><p><strong>Conclusions: </strong>In the absence of access to TDM, when prescribing nifedipine to clozapine-treated patients, we recommend reducing the daily dose of clozapine by one-third because of the weak inhibition of clozapine metabolism. With access to TDM, TDM should guide dosing as unusual patients may need larger dose reductions, as it is possible that in some patients, nifedipine may be a moderate inhibitor requiring halving clozapine dose. Further prospective studies are warranted.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 3","pages":"438-441"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144027555","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":"Mechanism-Based Pharmacokinetic/Pharmacodynamic Model of Voriconazole for Predicting the Clinical Outcomes of Adult Patients With Invasive Aspergillosis.","authors":"Monchai Duangpraphat, Richard C Wilson, Timothy M Rawson, Wichai Santimaleeworagun, Worapong Nasomsong, Alison H Holmes, Vasin Vasikasin","doi":"10.1097/FTD.0000000000001268","DOIUrl":"10.1097/FTD.0000000000001268","url":null,"abstract":"<p><strong>Background: </strong>Voriconazole is the first-line therapy for invasive aspergillosis (IA). To determine the minimum inhibitory concentration of Aspergillus, a voriconazole pharmacokinetic-pharmacodynamic (PK-PD) model linked to galactomannan response was developed and evaluated, and its clinical correlation for IA treatment was elucidated.</p><p><strong>Methods: </strong>Adult patients with probable or definite IA and at least one serum voriconazole measurement were included. A two-compartment voriconazole PK model was linked to a previously described PD model of galactomannan response. PK and PD parameters were estimated using a nonparametric adaptive grid technique. The relationship between the ratio of voriconazole exposure that induced half-maximum galactomannan response (EC50) and the observed terminal galactomannan concentration was evaluated. The factors associated with the PK-PD parameters and mortality were also determined.</p><p><strong>Results: </strong>Between January 2013 and December 2022, 41 patients were prescribed voriconazole for IA. The 30-day mortality rate was 17%. A high correlation was found for the observed-predicted Bayesian posterior estimates of voriconazole and galactomannan levels. Moreover, a nonlinear relationship was identified between AUC:EC50 and terminal galactomannan. The factors associated with higher AUC:EC50 were intravenous administration and intubation. In the survival analysis, higher EC50 tended to be associated with mortality, higher AUC was significantly associated with increased mortality, and higher AUC:EC50 tended to be associated with higher mortality. After adjusting for the intravenous route, higher AUC and AUC:EC50 were not associated with mortality.</p><p><strong>Conclusions: </strong>Individual EC50 estimation can provide insights into in vivo host and organism responses. Elevated EC50 showed comparable and unfavorable trends to higher minimum inhibitory concentration. Thus, determining EC50 might help guide individualized target serum voriconazole levels.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"378-384"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12061369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508530","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}

{"title":"Analytical Documentation of a Purple Urine Bag Syndrome Case.","authors":"Alexandr Gish, Apolline Saint Omer, Juliette Faillie, Arnaud Lionet, Aghiles Hamroun, Olivier Gaillot, Marie Lenski, Jean-Michel Gaulier","doi":"10.1097/FTD.0000000000001313","DOIUrl":"10.1097/FTD.0000000000001313","url":null,"abstract":"","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"442-443"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143493626","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":"Dose Optimization of Amikacin in the Emergency Department: A Population Pharmacokinetics Simulation Study.","authors":"Nada Dia, Sabrina De Winter, Matthias Gijsen, Stefanie Desmet, Peter Vanbrabant, Willy Peetermans, Isabel Spriet, Erwin Dreesen","doi":"10.1097/FTD.0000000000001279","DOIUrl":"10.1097/FTD.0000000000001279","url":null,"abstract":"<p><strong>Background: </strong>In adult patients with sepsis or septic shock admitted to the emergency department, a single intravenous 15 mg/kg amikacin dose provides inadequate pharmacokinetic-pharmacodynamic target attainment at the locally reported minimum inhibitory concentration (MIC) of 2 mg/L and the European Committee on Antimicrobial Susceptibility Testing clinical breakpoint for Enterobacterales of 8 mg/L.</p><p><strong>Objectives: </strong>To provide an amikacin dosing strategy with a clinically acceptable probability of target attainment (PTA) for all patients.</p><p><strong>Methods: </strong>Stochastic simulations were performed using a two-compartment population pharmacokinetics model of amikacin (NONMEM 7.5). PTA was evaluated for various dosing strategies across a range of virtual patients' body weight, body mass index, serum total protein, serum sodium, fluid balance, and estimated glomerular filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration equation (eGFR CKD-EPI ), at the locally reported MIC of 2 mg/L and the clinical breakpoint of 8 mg/L. The pharmacokinetic-pharmacodynamic targets were a 24-hour area under the concentration-time curve (AUC 24h )/MIC of ≥80 and a 24-hour postdose concentration (C 24h ) of < 3 mg/L for efficacy and safety, respectively.</p><p><strong>Results: </strong>The PTA for the clinical breakpoint of 8 mg/L was <90% with standard 15 mg/kg dosing, across all patient characteristics. A flat 1500-mg dose achieved ≥90% PTA for the entire population at a MIC of 2 mg/L. However, at the clinical breakpoint of 8 mg/L, a flat 3500-mg dose provided ≥90% PTA only when the eGFR CKD-EPI was <96 mL/min/1.73 m 2 . The C 24h was similar for 1500 mg and 15 mg/kg dosing, whereas 3500 mg resulted in a higher C 24h .</p><p><strong>Conclusions: </strong>A flat dose is recommended over weight-based dosing. However, selecting a 1500-mg or 3500-mg dose may compromise either efficacy (MIC 2 mg/L) or safety (clinical breakpoint 8 mg/L), posing a dilemma. Clinical validation is warranted.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":"47 3","pages":"353-362"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049343","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":"Lamotrigine Use in Lactating Women: Passage Into Breast Milk and Infant Exposure.","authors":"Daphne den Besten-Bertholee, Ilse Wegner, Daan J Touw, Peter G J Horst, Paola Mian","doi":"10.1097/FTD.0000000000001299","DOIUrl":"10.1097/FTD.0000000000001299","url":null,"abstract":"<p><strong>Background: </strong>Lamotrigine, an antiseizure medication used for epilepsy and bipolar disorders, is often prescribed to women of childbearing age due to relatively low teratogenic risk. It is known that lamotrigine use in lactation leads to detectable concentrations in breast milk, although concentrations vary significantly among individuals.</p><p><strong>Case presentation: </strong>A 35-year-old pregnant woman with epilepsy presented to our outpatient clinic. She was seizure-free and was taking lamotrigine 200 mg once daily. She is highly motivated to breastfeed her baby after birth but is concerned about the infant's exposure to lamotrigine through lactation. Lamotrigine concentrations were measured in both the breast milk and plasma of the suckling infants.</p><p><strong>Conclusions: </strong>Although lamotrigine is excreted into breast milk, and detectable in infants, the benefits of breastfeeding should not be overlooked. Higher plasma concentrations generally lead to higher breast milk concentrations, so aiming for the lowest possible maternal plasma levels is beneficial. These findings underscore the importance of TDM in this population.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"317-319"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839787","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":"Development and Validation of a High-Performance Liquid Chromatography-Ultraviolet Spectrometry Method for Ampicillin and Its Application in Routine Therapeutic Drug Monitoring of Intensive Care Patients.","authors":"Benedict Morath, Linda Schultes, Otto Roman Frey, Anka Christa Röhr, Hannes Christow, Torsten Hoppe-Tichy, Alexander Brinkmann, Ute Chiriac","doi":"10.1097/FTD.0000000000001253","DOIUrl":"10.1097/FTD.0000000000001253","url":null,"abstract":"<p><strong>Background: </strong>Ampicillin/sulbactam, a combination of a β-lactam and β-lactamase inhibitor, is widely used in clinical settings. However, therapeutic drug monitoring (TDM) of ampicillin is not commonly performed, particularly in intensive care units (ICUs). The purpose of this study was to develop and validate a rapid and cost-effective high-performance liquid chromatography (HPLC)-ultraviolet spectrometry method to quantify ampicillin in human serum and evaluate its clinical application in ICU patients.</p><p><strong>Methods: </strong>Sample cleanup included a protein precipitation protocol, followed by chromatographic separation on a C18 reverse-phase HPLC column within 12.5 minutes using gradient elution of the mobile phase. The assay was validated according to the German Society of Toxicology and Forensic Chemistry criteria. Clinical applications involved the retrospective analysis of TDM data from ICU patients receiving continuous infusion of ampicillin/sulbactam, including the attainment of target ranges and individual predicted and observed pharmacokinetics.</p><p><strong>Results: </strong>The method was robust, with linear relations between the peak area responses and drug concentrations in the range of 2-128 mg/L. The coefficient of variation for precision and the bias for accuracy (both interday and intraday) were less than 10%. Clinical application revealed variable pharmacokinetics of ampicillin in ICU patients (clearance of 0.5-31.2 L/h). TDM-guided dose adjustments achieved good therapeutic drug exposure, with 92.9% of the samples being within the optimal (16-32 mg/L) or quasioptimal (8-48 mg/L) range.</p><p><strong>Conclusions: </strong>This method provides a practical solution for the routine TDM of ampicillin, facilitating individualized dosing strategies to ensure adequate therapeutic drug exposure. Given its simplicity, cost-effectiveness, and clinical relevance, HPLC-ultraviolet spectrometry holds promise for broad implementation in hospital pharmacies and clinical laboratories.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"370-377"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12061375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296134","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}

{"title":"Unbound Ceftriaxone Concentrations in Plasma Measured Using Ultrafiltration Versus Equilibrium Dialysis.","authors":"Matthias Gijsen, Dorian Vanneste, Pieter Annaert, Yves Debaveye, Joost Wauters, Isabel Spriet","doi":"10.1097/FTD.0000000000001294","DOIUrl":"10.1097/FTD.0000000000001294","url":null,"abstract":"<p><strong>Background: </strong>Ceftriaxone is a first-line beta-lactam antibiotic used in diverse clinical settings. Owing to pharmacokinetic alterations, ceftriaxone therapeutic drug monitoring is currently recommended for patients in the intensive care unit. Ultrafiltration is typically used to measure unbound ceftriaxone concentrations, as it is less costly and time-consuming compared with equilibrium dialysis. However, the reference method, equilibrium dialysis, has not been compared with equilibrium dialysis for ceftriaxone to measure the unbound ceftriaxone concentrations. Therefore, unbound ceftriaxone fractions measured by ultrafiltration versus equilibrium dialysis were compared in patients in the intensive care unit.</p><p><strong>Methods: </strong>Total and unbound ceftriaxone plasma fractions were measured by ultrafiltration (9500 g at 37°C for 30 minutes) and equilibrium dialysis (12 kDa, 37°C for 4 hours) in 32 plasma samples from 28 patients who were critically ill collected during a previous prospective pharmacokinetic study. Passing-Bablok regression and Bland-Altman analyses were performed to evaluate the agreements between both methods.</p><p><strong>Results: </strong>The median (range) total ceftriaxone plasma concentration was 108.6 (5.2-233) mg/L. The median unbound concentration measured by equilibrium dialysis and ultrafiltration was 14.5 (0.7-52.9) and 23.3 (0.9-79.2) mg/L, respectively, showing a significant difference. Passing-Bablok regression analysis revealed significant proportional and systematic bias. This result was confirmed by Bland-Altman analysis, with a mean relative bias of 43.3% and wide agreement limits (-21% to 108%).</p><p><strong>Conclusions: </strong>Ultrafiltration substantially overestimates the unbound ceftriaxone fraction compared with equilibrium dialysis at 37°C. It is important to report methodological details and consider this information when interpreting unbound fractions of ceftriaxone and other drugs. These findings may impact the therapeutic drug monitoring of ceftriaxone.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"427-432"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808280","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":"Effect of Augmented Renal Clearance and Febrile Neutropenia on Initial Trough Level and Clearance of Teicoplanin.","authors":"Nozomi Kondo, Ryota Tanaka, Ryosuke Tatsuta, Haruka Tsushita, Takehiro Hashimoto, Kazufumi Hiramatsu, Hiroki Itoh","doi":"10.1097/FTD.0000000000001320","DOIUrl":"10.1097/FTD.0000000000001320","url":null,"abstract":"<p><strong>Background: </strong>Augmented renal clearance (ARC) and febrile neutropenia (FN) increase drug clearance primarily through glomerular filtration. In this study, we evaluated the influence of ARC and FN on dose-normalized trough concentration (C/D) and/or clearance of teicoplanin (TEIC) by comparing C/D between patients with ARC and non-ARC, and C/D and clearance between patients with FN and non-FN.</p><p><strong>Methods: </strong>This retrospective, single-center, observational cohort study enrolled 309 patients who received intravenous injections of TEIC between July 2016 and September 2021. Of the 94 patients who met the selection criteria, 25 satisfied the ARC definition, and 31 satisfied the FN definition. Using the Chronic Kidney Disease Epidemiology Collaboration formula, ARC was defined as an estimated glomerular filtration rate of 96.5 mL/min/1.73 m 2 or higher. FN was defined as an axillary temperature 37.5°C or higher and neutrophil count of less than 500/μL. TEIC clearance was estimated using a population pharmacokinetic model for adult Japanese patients with Bayesian estimation.</p><p><strong>Results: </strong>Compared with the non-ARC group (n = 69), the ARC group (n = 25) had a significantly lower first trough concentration ( P = 0.014) and lower C/D ( P = 0.009). By contrast, the FN (n = 31) and non-FN (n = 63) groups did not differ significantly in the first trough concentration, C/D, or clearance ( P = 0.294, 0.945, and 0.337, respectively). Forced-entry multiple regression analysis identified ARC as the only independent factor associated with C/D ( P = 0.001).</p><p><strong>Conclusions: </strong>A higher TEIC loading dose may be required for patients with ARC, regardless of the presence or absence of FN.</p>","PeriodicalId":23052,"journal":{"name":"Therapeutic Drug Monitoring","volume":" ","pages":"385-392"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721465","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":"413-420"},"PeriodicalIF":2.8,"publicationDate":"2025-06-01","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}