scholarly journals Clinical Value of Emerging Bioanalytical Methods for Drug Measurements: A Scoping Review of Their Applicability for Medication Adherence and Therapeutic Drug Monitoring

Drugs ◽  
2021 ◽  
Author(s):  
Tanja R. Zijp ◽  
Zamrotul Izzah ◽  
Christoffer Åberg ◽  
C. Tji Gan ◽  
Stephan J. L. Bakker ◽  
...  
Author(s):  
Philip B. Mitchell

AbstractTherapeutic drug monitoring (TDM) of many of the tricyclic antidepressants (TCAs) has been demonstrated to be of clear clinical value. This article reviews studies of TDM for the selective serotonin reuptake inhibitors (SSRIs) and other non-tricyclic antidepressants such as venlafaxine, nefazodone, trazodone, mianserin and bupropion. No definitive therapeutic concentrations have been demonstrated for these agents, nor have levels indicative of toxicity been reported. The major benefit of TDM for these agents would appear to be in the assessment of the apparently treatment-refractory depressed patient, to determine whether such lack of response is related to inadequate levels that would suggest either poor compliance, ultra-rapid metabolism, or drug interactions leading to induction of metabolising enzymes. Potential future applications of TDM, in conjunction with genotyping of cytochrome P450 enzymes and pharmacogenomic evaluations, are discussed.


Hypertension ◽  
2019 ◽  
Vol 74 (Suppl_1) ◽  
Author(s):  
Kevin Schesing ◽  
Shishir Sharma ◽  
Hamza Lodhi ◽  
Bryan Wu ◽  
Sandeep R Das ◽  
...  

Rheumatology ◽  
2019 ◽  
Vol 59 (2) ◽  
pp. 386-397 ◽  
Author(s):  
Ruud H J Verstegen ◽  
Rhona McMillan ◽  
Brian M Feldman ◽  
Shinya Ito ◽  
Ronald M Laxer

Abstract Objectives Before a clinician decides whether treatment with TNF inhibition in children with JIA has failed, one should ensure adequate systemic exposure has been achieved. Therapeutic drug monitoring might allow for improved treatment outcome with lower treatment-associated costs. However, this requires understanding of the pharmacokinetic (PK) characteristics, and the pharmacokinetic/pharmacodynamic (PK/PD) relationship for children with JIA. We performed a scoping review to summarize the available literature and identify areas for future research. Methods A systematic search was conducted of the Medline, EMBASE, Web of Science and Cochrane databases as well as the clinicaltrials.gov registry. In total, 3959 records were screened and 130 publications were selected for full text assessment. Results Twenty publications were included and divided into three categories: PK (n = 9), PK/PD (n = 3) and anti-drug antibodies (n = 13). Industry involvement was significant in 14 publications. Although data are limited, systemic exposure to TNF inhibitors is generally lower in younger children but meta-analysis is not possible. The PK/PD relationship has had limited study but there is partial evidence for infliximab. Anti-drug antibodies are common, and are related to impaired clinical outcome with adalimumab and infliximab therapy. Conclusion The current knowledge about the PK and PK/PD of TNF inhibitors in the treatment of children with JIA is limited, which prevents the introduction of TDM. Re-analysis of available data from previous trials, incorporation of pharmacologic assessments into existing biorepository studies as well as new prospective PK and PK/PD trials are required to obtain this knowledge.


Bioanalysis ◽  
2020 ◽  
Vol 12 (24) ◽  
pp. 1767-1786
Author(s):  
Mohsin Ali ◽  
Muhammad Usman ◽  
Huma Rasheed ◽  
Georg Hempel ◽  
Hafiz A Nawaz ◽  
...  

A fully validated bioanalytical methods are prerequisite for pharmacokinetic and bioequivalence studies as well as for therapeutic drug monitoring. Due to high pharmacokinetic variability and narrow therapeutic index, vancomycin requires reliable quantification methods for therapeutic drug monitoring. To identify published chromatographic based bioanalytical methods for vancomycin in current systematic review, PubMed and ScienceDirect databases were searched. The selected records were evaluated against the method validation criteria derived from international guidelines for critical assessment. The major deficiencies were identified in method validation parameters specifically for accuracy, precision and number of calibration and validation standards, which compromised the reliability of the validated bioanalytical methods. The systematic review enacts to adapt the recommended international guidelines for suggested validation parameters to make bioanalysis reliable.


2019 ◽  
Vol 72 (2) ◽  
Author(s):  
Donna Leung ◽  
Mary H H Ensom ◽  
Roxane Carr

<p><strong>ABSTRACT</strong><br /><strong></strong></p><p><strong>Background:</strong> Therapeutic drug monitoring (TDM) is helpful in situations where a drug has a narrow therapeutic index, a drug dosage does not reliably predict serum concentration, or a serum drug concentration has surrogate value (i.e., is reflective of clinical outcomes). TDM is especially important for the pediatric population, where wide variability in pharmacokinetics and differences in body composition and drug disposition exist. Unfortunately, very little is known about pediatric TDM patterns and the factors that affect the ordering of serum drug measurements. <br /><strong></strong></p><p><strong>Objectives:</strong> To describe TDM practice for pediatric patients in Canada, to report on the drugs that are monitored and how they are monitored, and to discern factors that influence pediatric TDM patterns. <br /><strong></strong></p><p><strong>Methods:</strong> An electronic survey was developed with online survey software and was disseminated to 42 pediatric health care centres in Canada over the period January to March 2016. <br /><strong></strong></p><p><strong>Results:</strong> Of the 42 sites invited to participate in the survey, 20 (48%) responded. All sites reported performing TDM for pediatric patients, and the median number of drugs monitored was 18.5 (range 9–28) per site. The sites differed in terms of TDM practice (e.g., indications for TDM, types of serum drug measurements). Pharmacogenetic testing currently does not play a major role in TDM. Reported barriers to TDM practice include perceived lack of clinical value for certain drugs, limited access to analytical testing, and delayed return of test results.<br /><strong></strong></p><p><strong>Conclusions:</strong> TDM practice is widespread in Canada. To better utilize TDM for clinical practice, future efforts can be aimed toward increasing awareness of the clinical value of TDM and improving the timeliness of access to TDM results.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte :</strong> Le suivi thérapeutique pharmacologique est utile dans les cas où un médicament possède un indice thérapeutique étroit, si une posologie ne permet pas d’établir de façon fiable les concentrations sériques ou si les concentrations sériques d’un médicament ont une valeur de substitution (c’est-à-dire qu’elles reflètent les résultats cliniques). Le suivi thérapeutique pharmacologique est particulièrement important pour la population pédiatrique, où il existe une grande variabilité pharmacociné-tique et des différences quant à la composition corporelle et au devenir des médicaments dans l’organisme. Malheureusement, on ne connaît que peu de choses à propos des habitudes de suivi thérapeutique pharmacologique de l’enfant et des facteurs qui influencent la prescription d’examens mesurant les concentrations sériques des médicaments. </p><p><strong>Objectifs :</strong> Offrir un portrait des habitudes de suivi thérapeutique pharmacologique de la population pédiatrique au Canada, faire un compte rendu des médicaments qui nécessitent un suivi et la manière dont se déroule cette surveillance et déceler les facteurs qui influencent les habitudes de suivi thérapeutique pharmacologique de l’enfant. <br /><strong></strong></p><p><strong>Méthodes :</strong> Un sondage électronique a été mis au point à l’aide d’un logiciel de sondage en ligne puis envoyé à 42 centres de soins pédiatriques au Canada de janvier à mars 2016. <br /><strong></strong></p><p><strong>Résultats :</strong> Vingt (48 %) des 42 établissements interrogés ont répondu au sondage. Tous les établissements ont indiqué réaliser des suivis thérapeutiques pharmacologiques auprès de la population pédiatrique et le nombre médian de médicaments nécessitant une surveillance était de 18,5 (écart de 9 à 28) par établissement. Les établissements présentaient des différences en ce qui a trait aux habitudes de suivi thérapeutique pharmacologique (comme les indications pour les suivis thérapeutiques pharmacologiques et les types de mesures sériques de médicaments). À ce jour, les examens pharmacogénétiques ne jouent pas un rôle important dans le suivi thérapeutique pharmacologique. Selon les répondants, des éléments faisaient obstacle à la réalisation du suivi thérapeutique pharmacologique, notamment la croyance que certains médicaments n’ont pas de valeur clinique, l’accès limité à des tests diagnostiques et les retards dans l’obtention des résultats d’examen.<br /><strong></strong></p><p><strong>Conclusions :</strong> La réalisation du suivi thérapeutique pharmacologique est répandue au Canada. Afin de l’exercer de façon plus optimale dans le cadre de la pratique clinique, le personnel de la santé doit être davantage sensibilisé à la valeur clinique du suivi thérapeutique pharmacologique et il est nécessaire d’améliorer la rapidité d’accès aux résultats de ce suivi.</p>


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