Overview of Therapeutic Drug Monitoring

Clarke, William

doi:10.1016/b978-0-12-802025-8.00001-5

Cited by 15 publications

(20 citation statements)

References 31 publications

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“…Modern pharmacometric methods can be traced back to the late sixties and owes much to the seminal contributions of Lewis Sheiner at the University of California San Francisco (Holford and Sheiner, 1982). Interestingly, his efforts started with the aim of improving patient care through therapeutic drug monitoring (TDM) (Sheiner et al, 1975), i.e., the measurement of circulating concentrations of a drug to adjust its dosing regimen, so as to reach a defined target exposure associated with optimal efficacy and minimal toxicity (Clarke, 2016). TDM was rather new practice at this time.…”

Section: Introductionmentioning

confidence: 99%

“…In the 1960s, the monitoring of blood concentrations of a few drugs with narrow therapeutic index was shown to improve their safety, and became widely available: this was the case for lithium, digoxin, phenytoin, phenobarbital, theophylline, and the aminoglycosides. Thereafter, this list integrated vancomycin, carbamazepine, cyclosporine, and tacrolimus, which still currently represent the therapeutic molecules most commonly measured in blood (Clarke, 2016). The introduction of all this TDM into clinical practice essentially followed empirical approaches, with little PK-PD support and scarce validation by randomized controlled trials.…”

Section: Introductionmentioning

confidence: 99%

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The Steps to Therapeutic Drug Monitoring: A Structured Approach Illustrated With Imatinib

et al. 2020

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Pharmacometric methods have hugely benefited from progress in analytical and computer sciences during the past decades, and play nowadays a central role in the clinical development of new medicinal drugs. It is time that these methods translate into patient care through therapeutic drug monitoring (TDM), due to become a mainstay of precision medicine no less than genomic approaches to control variability in drug response and improve the efficacy and safety of treatments. In this review, we make the case for structuring TDM development along five generic questions: 1) Is the concerned drug a candidate to TDM? 2) What is the normal range for the drug's concentration? 3) What is the therapeutic target for the drug's concentration? 4) How to adjust the dosage of the drug to drive concentrations close to target? 5) Does evidence support the usefulness of TDM for this drug? We exemplify this approach through an overview of our development of the TDM of imatinib, the very first targeted anticancer agent. We express our position that a similar story shall apply to other drugs in this class, as well as to a wide range of treatments critical for the control of various life-threatening conditions. Despite hurdles that still jeopardize progress in TDM, there is no doubt that upcoming technological advances will shape and foster many innovative therapeutic monitoring methods.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Steps to Therapeutic Drug Monitoring: A Structured Approach Illustrated With Imatinib

et al. 2020

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“…The electrochemical sensing was carried out using Compactstat.h potentiostat (Ivium Technologies, Eindhoven, the Netherlands), along with IviumSoft version 2.783 [ 3 ] (designed to work with Ivium designed electrochemical setup). To get the optimum results, the electrochemical setup was first optimized after several iterations.…”

Section: Methodsmentioning

confidence: 99%

“…The use of TDM for most medications is undesirable and therefore it is primarily used for tracking drugs: (a) with limited therapeutic ranges, (b) with significant pharmacokinetic variation, (c) for which target doses are difficult to control, and (d) known to cause therapeutic and adverse effects. However, TDM is yet to be widely used, especially in developing countries, due to the required blood-level analysis methods [ 2 , 3 ]. Including immunoassay or liquid chromatography with tandem mass spectroscopy (LC-MS/MS), these blood-level assessments remain prohibitively costly (approximately USD 60–200 per sample per person), and as a result, are yet to gain significant social traction, due to fundamental engineering challenges, in those communities most in need and most at risk.…”

Section: Introductionmentioning

confidence: 99%

A “Single-Use” Ceramic-Based Electrochemical Sensor Chip Using Molecularly Imprinted Carbon Paste Electrode

Aaryashree

Takeda

Kanai

et al. 2020

Sensors

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An inexpensive disposable electrochemical drug sensor for the detection of drugs (vancomycin, meropenem, theophylline, and phenobarbital) is described. Molecularly imprinted polymer (MIP) templated with the target drugs was immobilized on the surface of graphite particles using a simple radical polymerization method and packed into the working electrode of a three-electrode ceramic-based chip sensor. Differential pulse voltammetry (DPV) was used to determine the relationship between the response current and the concentration of the targeted drug while using one sensor chip for one single operation. The time required for each DPV measurement was less than 2 min. Concentrations corresponding to the therapeutic range of these drugs in plasma were taken into account while performing DPV. In all the cases, the single-used MIP sensor showed higher sensitivity and linearity than non-imprinted polymer. The selectivity test in drugs with a structure similar to that of the target drugs was performed, and it was found that MIP-based sensors were more selective than the untreated ones. Additionally, the test in whole blood showed that the presence of interfering species had an insignificant effect on the diagnostic responses of the sensor. These results demonstrate that the disposable MIP-sensor is promising for quick and straightforward therapeutic drug monitoring to prevent the toxic side effects and the insufficient therapeutic effect due to the overdose and underdose, respectively.

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“…In the treatment of infectious diseases, the therapeutic index (TI) of antimicrobials can show significant pharmacokinetic (PK) variability. It is of great importance to know the concentration of the antibiotic, which must be higher than the minimum effective concentration (MEC) for a favorable clinical outcome for the patient [ 1 ] to avoid antibiotic-resistant bacteria [ 2 ]. The measurement of the concentration of drugs in fluids such as plasma, serum, or blood in patients at specific intervals is called therapeutic drug monitoring (TDM) [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

Carbapenem Therapeutic Drug Monitoring in Critically Ill Adult Patients and Clinical Outcomes: A Systematic Review with Meta-Analysis

et al. 2021

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Drug monitoring is one strategy of antibiotic stewardship to face antimicrobial resistance. This strategy could have a determinant role in critically ill patients treated with carbapenems to overcome pharmacokinetic variability, reduce the risk of subtherapeutic dosage or toxicity, and reduce the risks inherent to treatment. However, the effectiveness of therapeutic drug monitoring (TDM) is unknown. This paper aims to identify TDM effectiveness in critically ill patients treated with carbapenems. English and ClinicalTrials.gov databases were searched to identify relevant studies evaluating carbapenem TDM. Randomized controlled trials (RCTs) and comparative cohort studies were selected for inclusion if they compared carbapenem TDM to standard care in adult critically ill or sepsis/septic shock patients. The primary outcome was mortality. Secondary outcomes included morbidity, clinical cure, microbiological eradication, antimicrobial resistance, drug-related side effects, and achievement of target plasma concentrations. Overall, performing carbapenem TDM was not associated with a decrease in mortality. However, it could be evidence for a relationship with clinical cure as well as target attainment. Some studies found favorable outcomes related to clinical and microbiological responses, such as lower procalcitonin levels at the end of the monitored therapy compared to standard care. For the primary and secondary outcomes analyzed, strong evidence was not identified, which could be due to the size, risk of bias, and design of selected studies.

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Overview of Therapeutic Drug Monitoring

Cited by 15 publications

References 31 publications

The Steps to Therapeutic Drug Monitoring: A Structured Approach Illustrated With Imatinib

The Steps to Therapeutic Drug Monitoring: A Structured Approach Illustrated With Imatinib

A “Single-Use” Ceramic-Based Electrochemical Sensor Chip Using Molecularly Imprinted Carbon Paste Electrode

Carbapenem Therapeutic Drug Monitoring in Critically Ill Adult Patients and Clinical Outcomes: A Systematic Review with Meta-Analysis

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