Abstract:
:The immunosuppressants cyclosporine, tacrolimus, sirolimus, everolimus, and probably also mycophenolic acid require therapeutic drug monitoring (TDM)-guided dosing to ensure that blood concentrations are kept within the target range in transplant patients. Reliable, accurate, and precise test methods are therefore essential to effectively monitor levels and to make proper dose adjustments. Data from proficiency testing programs have shown substantial interlaboratory variability. Only few attempts have been made to study the underlying causes. The aim of this study was to systematically document current practices used for immunosuppressant drug TDM in clinical laboratories and identify methodological and practice differences, which may cause the variability observed among laboratories. Data collection was primarily conducted by a structured Web-based survey. Invitations to participate in the survey were distributed to clinical laboratories providing immunosuppressant drug TDM. Surveys were completed by 76 laboratories in 14 countries. The results of our survey suggest that there are 3 main reasons for interlaboratory variability: (1) lack of standardization of laboratory procedures and workflows starting with sample collection and handling, (2) lack of use of appropriate reference materials (eg, isotope-labeled internal standards for liquid chromatography-tandem mass spectroscopy), and (3) poor compliance with internationally accepted good laboratory practice guidelines (eg, related to quality control, quality assurance, validation, training of personnel). The results of the survey also suggest that interlaboratory variability is a multifactorial problem. Technical-level consensus on laboratory operational procedures, quality systems, and personnel training will be of great importance to improve quality and interlaboratory comparability.
journal_name
Ther Drug Monitjournal_title
Therapeutic drug monitoringauthors
Christians U,Vinks AA,Langman LJ,Clarke W,Wallemacq P,van Gelder T,Renjen V,Marquet P,Meyer EJdoi
10.1097/FTD.0000000000000205subject
Has Abstractpub_date
2015-12-01 00:00:00pages
718-24issue
6eissn
0163-4356issn
1536-3694journal_volume
37pub_type
杂志文章abstract::A neurophysiologic test battery (consisting of a 24-hour, seven-channel electroencephalogram [EEG], EEG spectral analysis, multiple sleep latency test, visual evoked potentials, critical flicker fusion, and visual contrast sensitivity) was administered twice to 16 patients with juvenile myoclonic epilepsy (JME) in a d...
journal_title:Therapeutic drug monitoring
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1999-02-01 00:00:00
abstract::Plasma concentrations of isepamicin, a new aminoglycoside antibiotic, were determined by radioimmunoassay (RIA), microbiological assay (MA), and high-performance liquid chromatography (HPLC) in healthy volunteers after administration of 7.5 mg/kg intramuscular dosages once daily for 10 days. Plasma samples were collec...
journal_title:Therapeutic drug monitoring
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journal_title:Therapeutic drug monitoring
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journal_title:Therapeutic drug monitoring
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Therapeutic drug monitoring
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journal_title:Therapeutic drug monitoring
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doi:10.1097/FTD.0b013e318296be01
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journal_title:Therapeutic drug monitoring
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doi:10.1097/00007691-200112000-00021
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journal_title:Therapeutic drug monitoring
pub_type: 临床试验,杂志文章
doi:10.1097/00007691-199906000-00007
更新日期:1999-06-01 00:00:00
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更新日期:2008-02-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:10.1097/00007691-199806000-00013
更新日期:1998-06-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:10.1097/00007691-198403000-00015
更新日期:1984-01-01 00:00:00
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journal_title:Therapeutic drug monitoring
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更新日期:1989-01-01 00:00:00
abstract::The present study aims to determine the population pharmacokinetic parameters of cyclosporine (CsA) after multiple oral administration of the microemulsion formulation, Neoral, in kidney transplant patients and to propose a limited sampling strategy to predict AUC(0-4h) using them and the Bayesian method. The AUC(0-4h...
journal_title:Therapeutic drug monitoring
pub_type: 临床试验,杂志文章
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更新日期:2004-06-01 00:00:00
abstract::The immunosuppressive potential of mycophenolic acid (MPA) correlates well with MPA exposure [area under the concentration-time curve (AUC)]. Monitoring MPA AUC is important and helpful for maintaining the efficacy of mycophenolate mofetil while minimizing its side effects, but full MPA AUC monitoring is laborious, co...
journal_title:Therapeutic drug monitoring
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更新日期:2007-10-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:10.1097/00007691-198911000-00013
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:
更新日期:1980-01-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:10.1097/FTD.0000000000000806
更新日期:2021-02-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
doi:10.1097/00007691-199608000-00027
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journal_title:Therapeutic drug monitoring
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更新日期:1990-01-01 00:00:00
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更新日期:2010-12-01 00:00:00
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journal_title:Therapeutic drug monitoring
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更新日期:2002-06-01 00:00:00
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journal_title:Therapeutic drug monitoring
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-12-01 00:00:00
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journal_title:Therapeutic drug monitoring
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章,评审
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journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
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更新日期:2017-12-01 00:00:00
abstract::Urinary excretion of lipocalin-type prostaglandin D synthase (L-PGDS) has been suggested to be a useful biomarker of early diabetic nephropathy. We studied whether L-PGDS is also a marker of gentamicin (GM)-induced renal damage in the "creatinine-blind" range. A prospective study was conducted in 6 patients who were g...
journal_title:Therapeutic drug monitoring
pub_type: 杂志文章
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更新日期:2009-02-01 00:00:00