A systematic review on chromatography-based method validation for quantification of vancomycin in biological matrices

Bioanalysis ◽  
2020 ◽  
Vol 12 (24) ◽  
pp. 1767-1786
Author(s):  
Mohsin Ali ◽  
Muhammad Usman ◽  
Huma Rasheed ◽  
Georg Hempel ◽  
Hafiz A Nawaz ◽  
...  
Keyword(s):  
Systematic Review ◽  
Therapeutic Drug Monitoring ◽  
Method Validation ◽  
Drug Monitoring ◽  
Bioanalytical Methods ◽  
Therapeutic Index ◽  
Therapeutic Drug ◽  
International Guidelines ◽  
Validation Parameters ◽  
Reliable Quantification

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.

scholarly journals Thiopurines’ Metabolites and Drug Toxicity: A Meta-Analysis

2020 ◽  
Vol 9 (7) ◽  
pp. 2216
Author(s):  
Paula Sousa ◽  
Maria Manuela Estevinho ◽  
Cláudia Camila Dias ◽  
Paula Ministro ◽  
Uri Kopylov ◽  
...  
Keyword(s):  
Systematic Review ◽  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Alanine Aminotransferase ◽  
Odds Ratio ◽  
Drug Toxicity ◽  
Meta Analysis ◽  
Therapeutic Drug ◽  
Gastrointestinal Intolerance ◽  
The Relationship

Many questions remain unanswered regarding therapeutic drug monitoring (TDM) utility with thiopurines. This study aims to establish a relationship between thiopurines’ metabolites and drug toxicity. We performed a systematic review with inclusion of studies evaluating the relationship between thiopurines’ metabolites and drug toxicity. Meta-analysis of mean difference (MD), correlations and odds ratio (OR) was performed. We identified 21,240 records, 72 of which were eligible for meta-analysis. Levels of 6-thioguanine nucleotides (6-TGN) were higher in patients with leukopenia (MD 127.06 pmol/8 × 108 RBC) and gastrointestinal intolerance (MD 201.46 pmol/8 × 108 RBC), and lower in patients with hepatotoxicity (MD −40.6 pmol × 108 RBC). We established a significant correlation between 6-TGN and leukocytes (r = −0.21), neutrophils (r = −0.24) and alanine aminotransferase levels (r = −0.24). OR for leukopenia in patients with elevated 6-TGN was 4.63 (95% CI 2.24; 9.57). An optimal cut-off of 135 pmol/8 × 108 RBC for leukopenia was calculated (sensitivity 75.4%; specificity 46.4%). 6-methylmercaptopurine ribonucleotides (6-MMPR) were significantly associated with hepatotoxicity (MD 3241.2 pmol/8 × 108 RBC; OR 4.28; 95% CI 3.20; 5.71). Levels of 6-MMPR measured in the first 8 weeks of treatment were associated with leukopenia. We conclude that TDM could be used to prevent thiopurines’ toxicity. As optimal metabolites level may vary according to indication, physicians may adapt posology to decrease toxicity without compromising efficacy.

Is Therapeutic Drug Monitoring for Anti-tumour Necrosis Factor Agents in Adults With Inflammatory Bowel Disease Ready for Standard of Care? A Systematic Review and Meta-analysis

2020 ◽  
Vol 14 (8) ◽  
pp. 1057-1065 ◽  
Author(s):  
Raj Shah ◽  
Gila R Hoffman ◽  
Mohammed El-Dallal ◽  
Alexander M Goldowsky ◽  
Ye Chen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Meta Analysis ◽  
Therapeutic Drug ◽  
Quality Of Evidence ◽  
Inflammatory Bowel

Abstract Introduction Using therapeutic drug monitoring [TDM] in adult patients with inflammatory bowel disease [IBD] remains controversial. We conducted a systematic review and meta-analysis to answer four clinical PICO [Population, Intervention, Comparator, Outcome] questions. Methods We searched MEDLINE, Embase, Web of Science, and Cochrane Central from inception to June 30, 2019. Remission was defined by the manuscripts’ definitions of clinical remission. Data were analysed using RevMan 5.3. Quality of evidence was assessed with GRADE methodology. Results We identified and screened 3365 abstracts and 11 articles. PICO 1 Reactive vs No TDM: six studies pooled showed 57.1% [257/450] failed to achieve remission following reactive TDM vs 44.7% [268/600] in the no TDM group (risk ratio [RR]: 1.14; 95% confidence interval [CI] 0.88–1.47). PICO 2 Proactive vs no TDM: five studies pooled showed 19.5% [75/384] failed to maintain remission in the proactive TDM group vs 33.4% [248/742] in the no TDM group [RR: 0.60; 95% CI 0.35–1.04]. PICO 3 Proactive vs Reactive TDM: two retrospective studies pooled showed 14.2% [26/183] failure to maintain remission in the proactive TDM group and 64.7% [119/184] in the reactive TDM group [RR: 0.22; 95% CI 0.15–0.32]. PICO 4 TDM [proactive/reactive] vs No TDM: we pooled 10 studies showing 39.7% [332/837] failed to achieve remission in the TDM [proactive/reactive] cohort vs 40.3% [428/1063] in the no TDM cohort [RR: 0.94; 95% CI 0.77–1.14]. Overall, the quality of evidence in each PICO was very low when using GRADE. Conclusions This meta-analysis shows that data supporting use of TDM in adults are limited and of very low quality. Further well-designed randomized controlled trials are needed to determine the place of TDM in clinical practice.

Applications and challenges in therapeutic drug monitoring of cancer treatment: A review

2020 ◽  
pp. 107815522097904
Author(s):  
Bushra Salman ◽  
Murtadha Al-Khabori
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Anticancer Agents ◽  
Drug Monitoring ◽  
Cancer Therapeutics ◽  
Therapeutic Index ◽  
Therapeutic Drug ◽  
Narrow Therapeutic Index ◽  
Dose Individualization ◽  
Therapeutic Outcomes ◽  
Wide Variability

Most anticancer agents show wide variability in pharmacokinetics (PK) and have a narrow therapeutic index which makes fixed dosing suboptimal. To achieve the best therapeutic outcomes with these agents, many studies have postulated using PK or therapeutic drug monitoring (TDM)-guided dosing. However, multiple factors contribute to the variability in PKs making the application of TDM in practice challenging. Also, despite the known association with clinical outcomes, standard guidelines on PK-guided dosing are lacking for most agents. Understanding the factors that contribute to PK variability and their impact is essential for dose individualization. The purpose of this review is to discuss the factors that contribute to the PK variability of anticancer agents and the challenges faced in practice when individualizing doses for certain widely used agents. Searching the literature has identified several gaps and efforts are needed to ensure better targeting of cancer therapeutics.

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