Therapeutic Drug Monitoring in Pediatrics: A Need for Improvement

Tange, Susan M.; Grey, Vijaylaxmi; Senécal, Pierre E.

doi:10.1002/j.1552-4604.1994.tb03987.x

Cited by 13 publications

(10 citation statements)

References 168 publications

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“…Indeed, this notion has been initiated first by considering the underlying dysfunctions, mainly the dosage adjustment or even the change of the molecule carried out during renal or hepatic failure. Subsequently, clinicians have adopted the “therapeutic drug monitoring” for certain drug molecules, for which a blood concentration–therapeutic efficacy correlation is well established, associated with significantly different concentrations between patients taking the same dose of the same treatment, as is the case with ciclosporin or tacrolimus, known to have a narrow therapeutic window [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

Drug Response Diversity: A Hidden Bacterium?

Hannachi

Camoin-Jau

2021

JPM

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Interindividual heterogeneity in response to treatment is a real public health problem. It is a factor that can be responsible not only for ineffectiveness or fatal toxicity but also for hospitalization due to iatrogenic effects, thus increasing the cost of patient care. Several research teams have been interested in what may be at the origin of these phenomena, particularly at the genetic level and the basal activity of organs dedicated to the inactivation and elimination of drug molecules. Today, a new branch is being set up, explaining the enigmatic part that could not be explained before. Pharmacomicrobiomics attempts to investigate the interactions between bacteria, especially those in the gut, and drug response. In this review, we provide a state of the art on what this field has brought as new information and discuss the challenges that lie ahead to see the real application in clinical practice.

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Section: Introductionmentioning

confidence: 99%

Drug Response Diversity: A Hidden Bacterium?

Hannachi

Camoin-Jau

2021

JPM

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“…Otherwise, TDM refers to the individualization of drug dosage by maintaining plasma or blood drug concentrations within a targeted therapeutic range or window [ 2 ]. By combining knowledge of pharmaceutics, pharmacokinetics, and pharmacodynamics, TDM enables the assessment of the efficacy and safety of a particular medication in a variety of clinical settings [ 3 - 7 ]. The goal of this process is to individualize therapeutic regimens for optimal patient benefit.…”

Section: Introductionmentioning

confidence: 99%

“…Clinical pharmacists and pharmacologists use pharmacokinetic principles to assess these interpretations. The science of TDM introduced a new aspect of clinical practice in the 1960s with the publication of initial pharmacokinetic studies linking mathematical theories to patient outcomes [ 3 ]. From there, clinical pharmacokinetics emerged as a discipline in the late 1960s and early 1970s.…”

Section: Introductionmentioning

confidence: 99%

Overview of Therapeutic Drug Monitoring

Kang

Lee

2009

Korean J Intern Med

470

347

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Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. It is unnecessary to employ TDM for the majority of medications, and it is used mainly for monitoring drugs with narrow therapeutic ranges, drugs with marked pharmacokinetic variability, medications for which target concentrations are difficult to monitor, and drugs known to cause therapeutic and adverse effects. The process of TDM is predicated on the assumption that there is a definable relationship between dose and plasma or blood drug concentration, and between concentration and therapeutic effects. TDM begins when the drug is first prescribed, and involves determining an initial dosage regimen appropriate for the clinical condition and such patient characteristics as age, weight, organ function, and concomitant drug therapy. When interpreting concentration measurements, factors that need to be considered include the sampling time in relation to drug dose, dosage history, patient response, and the desired medicinal targets. The goal of TDM is to use appropriate concentrations of difficult-to-manage medications to optimize clinical outcomes in patients in various clinical situations.

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“…As mentioned previously, other authors problem of differing subpopulations has without doubt been encountered by others and overcome in a similar fashion to the proposed power walk design. We could not find in the literature, however, any discourse on have used single patient cohorts in order to accelerate the time to trial completion and minimize the number of patients treated at subclinical dose levels (2,3,16,28,29). The the implications of such an approach.…”

Section: Discussionmentioning

confidence: 99%

“…There is less certainty as to the magnitude and direction of that difference relative to toxicity, for example. Even within the pediatric popula-tion, the pharmacokinetic and other effects are affected by stage of development (28,29,30).…”

Section: Motivationmentioning

confidence: 99%

Phase 1 Oncology Clinical Trials for Related Subpopulations: The Power Walk Design

et al. 2002

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Motivcrtion/Background: This paper addresses designing a Phase 1 trial where the doseresponse curve differs across patient subpopulations. We examine a design which "power walks" through clinically ineffective dose levels, accruing from either subpopulation, until dose limiting toxicity appears. The design then splits into two Phase 1 trials for each subpopulation. Methods/Results:We performed simulation studies of I0000 Phase 1 trials comparing the "power walk" design to the alternatives. The power walk design correctly estimates the maximum tolerated dose (MTD) up to 20% more ojien. The power walk design performs best with a steep dose-response curve, and overestimates the MTD roughly 10% of the time. Conclusions:The power walk design is appropriate to obtain MTDs for separate patient subpopulations where the initial dose is clinically ineffective or substantially below the MTD. A power walk design study involves fewer patients and achieves the correct MTD more ofen. The power walk design is not recommended when the initial dose level is near the MTD.

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Therapeutic Drug Monitoring in Pediatrics: A Need for Improvement

Cited by 13 publications

References 168 publications

Drug Response Diversity: A Hidden Bacterium?

Drug Response Diversity: A Hidden Bacterium?

Overview of Therapeutic Drug Monitoring

Phase 1 Oncology Clinical Trials for Related Subpopulations: The Power Walk Design

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