Development and Validation of a Chromatographic Ultraviolet Method for the Quantification of Isavuconazole in Human Plasma Samples
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Letters to the Editor Source Type: research

Time-Dependent Decline in Serum Phenytoin Concentration With Heightened Convulsive Seizure Risk by Prolonged Administration of Fosphenytoin in Japanese: A Retrospective Study
Conclusions: Prolonged use of fosphenytoin, for such patients as those with autoimmune-mediated encephalopathy accompanied with reflux disease and/or ileus, time dependently decreased the serum concentration of phenytoin and increased the risk of convulsion. Therefore, the maintenance dose should be increased to maintain the therapeutic serum concentration. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Short Communication Source Type: research

Validation of an Isavuconazole High-Performance Liquid Chromatography Assay in Plasma for Routine Therapeutic Drug Monitoring Applications
Background: Isavuconazole is a triazole antifungal agent for treatment of invasive aspergillosis and mucormycosis. At present, it is unclear whether a therapeutic drug monitoring (TDM) of isavuconazole would be necessary. The aim of the investigation was to validate a high-performance liquid chromatography (HPLC) assay for routine applications. Methods: An HPLC assay for routine determination of isavuconazole in plasma has been adapted and validated. The assay used the reagents and HPLC column provided by the ChromSystems HPLC Kit for TDM of itraconazole, posaconazole, and voriconazole. Isocratic flow rate was set at ...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Short Communication Source Type: research

Preliminary Evidence for Enhanced Thymine Absorption: A Putative New Phenotype Associated With Fluoropyrimidine Toxicity in Cancer Patients
Conclusions: This small cohort provided evidence for a hypothesis that fluorouracil toxicity cases may include a previously undescribed pyrimidine absorption variant, “enhanced thymine absorption,” and elevated THY/DHT ratios in urine may predict fluorouracil toxicity. A prospective study is currently being conducted. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Short Communication Source Type: research

Methadone Maintenance Treatment: A 15-year Retrospective Study in Split-Dalmatia County, Croatia
Conclusions: The results of this study show the favorable epidemiological trend because of the decreasing number of new opiate patients in treatment. The retention of opiate patients in substitution therapy indicates the effectiveness of methadone maintenance programs. Our research did not determine any influence of methadone substitution therapy on an increasing risk of specific (overdose) mortality. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

A Liquid Chromatography-Mass Spectrometry Assay for Determination of Perampanel and Concomitant Antiepileptic Drugs in the Plasma of Patients With Epilepsy Compared With a Fluorescent HPLC Assay
Conclusions: The assay allows for highly sensitive and selective quantification of perampanel and concomitant AEDs in patient plasma samples and can be easily implemented in clinical settings. Our findings are in agreement with previously published data in patients comedicated with enzyme inducer AEDs, but seem to indicate a possible interaction in patients treated with the enzyme inhibitor drug valproic acid. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Development and Validation of an Ultra-Performance Liquid Chromatography–Tandem Mass Spectrometry Method for the Concurrent Measurement of Gabapentin, Lamotrigine, Levetiracetam, Monohydroxy Derivative of Oxcarbazepine, and Zonisamide Concentrations in Serum in a Clinical Setting
This study presents the development and validation of a clinical ultra-performance liquid chromatography–MS/MS method for the concurrent measurement of gabapentin, lamotrigine, levetiracetam, monohydroxy derivative of oxcarbazepine, and zonisamide in human serum. Methods: To determine the optimal assay analyte range, one year of AED therapeutic drug monitoring results (n = 1825) were evaluated. Simple protein precipitation with acetonitrile containing isotopically labeled internal standards was used. Reverse-phase ultra-performance liquid chromatography chromatographic separation was used, having a total run time ...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Comparison of CYP3A4-Inducing Capacity of Enzyme-Inducing Antiepileptic Drugs Using 4β-Hydroxycholesterol as Biomarker
Background: Enzyme-inducing antiepileptic drugs (EIAEDs) are among the clinically most important inducers of cytochrome P450 (CYP) 3A4, but there is limited evidence regarding the comparative potency of each EIAED in raising CYP3A4 activity. The aim of this study was to estimate CYP3A4-inductive potency of EIAEDs by comparing CYP3A4 activity in patients treated with carbamazepine, phenobarbital, or phenytoin. Methods: Residual serum samples from patients treated with EIAEDs or levetiracetam were collected from a therapeutic drug monitoring service for analysis of 4β-hydroxycholesterol (4βOHC), which is an in...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Impact of Drug Interactions on Clobazam and N-Desmethylclobazam Concentrations in Pediatric Patients With Epilepsy
This study characterizes the impact of CYP3A4 and CYP2C19 drug interactions on CLB and NCLB serum concentrations (Cp) and concentration/dose (Cp/D) ratios in pediatric patients with epilepsy. Methods: This was a retrospective chart review including patients older than 1 month, who received CLB between April 2012 and March 2017. Extracted data included patient demographics, CLB daily dose, CLB and NCLB Cp, calculated CLB and NCLB Cp/Cp and Cp/D ratios, and all concomitant drugs. Results: The study included 995 CLB concentration sets from 302 patients (median age 7.6 years and range 0.2–40.1 years). Pharmacokinet...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Effect of Valproate and Antidepressant Drugs on Clozapine Metabolism in Patients With Psychotic Mood Disorders
Background: The aim of the present study was to appraise retrospectively the influence of valproate (VPA) and antidepressants (ADs) on the steady-state plasma concentrations of clozapine (CLZ), the prototype of various second-generation antipsychotics, norclozapine (NCLZ, its main metabolite), and their ratio (NCLZ:CLZ). Methods: Sixty-seven psychotic patients with a prevalent diagnosis of bipolar disorder were studied. We then analyzed data altogether and subdivided them into 4 groups, according to pharmacological treatments: #1 CLZ (n = 21), #2 CLZ plus ADs (n = 13), #3 CLZ plus VPA (n = 16), and #4 CLZ plus ADs plu...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Interindividual and Intraindividual Variation of Methylphenidate Concentrations in Serum and Saliva of Patients With Attention-Deficit/Hyperactivity Disorder
Background: Therapeutic drug monitoring is becoming increasingly important in psychiatric therapy, especially in children. However, for several reasons, it cannot yet be implemented as a daily routine in clinical or outpatient settings. To evaluate new, noninvasive procedures, blood and saliva (oral fluid) samples were collected from patients with attention-deficit/hyperactivity disorder (ADHD) who were also being administered methylphenidate (MPH). The study's main purposes were to correlate MPH concentrations in serum and saliva between subjects and to analyze intraindividual variation of serum concentration. Methods:...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Pharmacokinetics of Doripenem in Healthy Koreans and Monte Carlo Simulations to Explore Optimal Dosage Regimens in Patients With Normal and Enhanced Renal Function
Conclusions: These results suggest that dosage adjustment such as increasing the dose or lengthening the infusion time should be considered in patients with normal or enhanced renal function. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Simultaneous Quantification of Adalimumab and Infliximab in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry
Conclusions: This LC-MS/MS method can be used for the quantification of ADA and IFX in a single analytical run and for the optimization of LC-MS/MS resource use in clinical pharmacology laboratories. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Development of an Abbreviated Mycophenolic Acid Area Under the Time–Concentration Curve for Renal Transplant Patients Under Enteric-Coated Mycophenolate Sodium: A Comparison With Critical Analysis of Available Equations
Conclusions: This analysis offers blood-sampling alternatives for MPA monitoring depending on the precision needed. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Survival Time to Biopsy-Proven Acute Rejection and Tacrolimus Adverse Drug Reactions in Pediatric Liver Transplantation
This study aimed to identify peritransplant predictors of AR and factors related to the risk of ADR to tacrolimus in a large Latin American cohort of pediatric liver transplant patients. Methods: We performed a retrospective cohort study in a pediatric liver transplant population (n = 72). Peritransplant variables were collected retrospectively including demographic, clinical, laboratory parameters, genomic (CYP3A5 donor and recipients polymorphism), and tacrolimus trough concentrations (C0) over a 2-year follow-up period. Variability in tacrolimus C0 was calculated using percent coefficient of variation and tortuosity....
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Large-Scale Variability of Inpatient Tacrolimus Therapeutic Drug Monitoring at an Academic Transplant Center: A Retrospective Study
Conclusions: Based on this large single-center study, the authors concluded that the inpatient TDM process is prone to timing errors, thus is financially wasteful, and at its worst harmful to patients due to clinical decisions being made on the basis of unreliable data. Further work is needed on systems solutions to better align the laboratory study collection and drug administration processes. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology
This article reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Review Article Source Type: research

Eltrombopag-Induced Acute Liver Failure in a Pediatric Patient: A Pharmacokinetic and Pharmacogenetic Analysis
We presented the case study of a 3-year-old girl with chronic ITP. She arrived in the pediatric intensive care unit with acute liver failure due to eltrombopag toxicity despite taking the standard drug dosage. A very high eltrombopag plasma concentration, indicating drug toxicity, was found through TDM. The patient also carried the allelic variations that are involved in drug metabolism [CYP2C8 and UDP glucuronosyltransferase (UGT) 1A1 (UGT1A1)] and drug cellular transportation [ABCG2 (ATP-binding cassette G2)]. This observation highlights the importance of using TDM and pharmacogenetic approaches to manage patients' unusu...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Grand Rounds Source Type: research

Therapeutic Drug Monitoring of Methotrexate in Plasma Using Ultra High-Performance Liquid Chromatography–Electrospray Ionization–Tandem Mass Spectrometry: Necessary After Administration of Glucarpidase in Methotrexate Intoxications
We present 2 children treated with HD-MTX and afterward treated with glucarpidase at different time-points after their HD-MTX infusions. After the administration of glucarpidase, a nontoxic metabolite of MTX cross-reacts with MTX in the standard immunoassay (Abbott Diagnostics, Hoofddorp, the Netherlands) resulting in an artificially elevated MTX level. An artificially elevated MTX level results in unnecessarily long folinic acid administration, which decreases the effectivity of MTX. This grand round highlights the importance of measuring plasma MTX levels after the administration of glucarpidase with an ultra high-perfor...
Source: Therapeutic Drug Monitoring - July 11, 2018 Category: Drugs & Pharmacology Tags: Grand Rounds Source Type: research

The relation between dosage, serum concentrations, and clinical outcome in children and adolescents treated with sertraline: a naturalistic study Erratum
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Cocaine Detection in Maternal and Neonatal Hair: Implications to Fetal Toxicology Expression of Concern
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Vancomycin Area Under the Curve Simplified
Conclusions: Troughs of 15–20 mg/L are rarely needed for organisms with an MIC of 1 mg/L or less. AUC24:MIC goals of greater than 400 can best be achieved with higher doses in mg/kg while targeting lower troughs. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Short Communication Source Type: research

Quantification of Apixaban, Dabigatran, Edoxaban, and Rivaroxaban in Human Serum by UHPLC-MS/MS—Method Development, Validation, and Application
Conclusions: The developed method fulfilled the set validation criteria, and its suitability was demonstrated in a routine setting. The instability of edoxaban may complicate the transport of routine samples to the laboratory. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Warfarin Dosing According to the Genotype-guided Algorithm is Most Beneficial in Patients With Atrial Fibrillation: A Randomized Parallel Group Trial
Conclusions: CYP2C9 and VKORC1 genotype-guided dosing of warfarin may be beneficial in patients diagnosed with AF. There is no evidence for such conclusion in patients with DVT and PE. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Effects of Cytochrome P450 (CYP) 2C19 Genotypes on Steady-State Plasma Concentrations of Escitalopram and its Desmethyl Metabolite in Japanese Patients With Depression
Conclusions: These findings suggest that the CYP2C19 variants are associated with steady-state plasma concentrations of escitalopram to some extent but are not associated with desmethylescitalopram. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Serum and Saliva Concentrations of Venlafaxine, O-Desmethylvenlafaxine, Quetiapine, and Citalopram in Psychiatric Patients
Background: Therapeutic drug monitoring has become increasingly important in psychiatric therapy. However, it is not yet implemented as a daily routine in clinical settings. To evaluate new, noninvasive procedures, we compared blood and saliva venlafaxine, quetiapine, and citalopram concentrations in samples collected from psychiatric patients. Methods: We collected blood and saliva samples from 75 psychiatric patients (39 venlafaxine, 19 quetiapine, and 17 citalopram). Saliva sampling was achieved by the use of cotton pads. Venlafaxine (and its metabolite O-desmethylvenlafaxine) and quetiapine were analyzed by LC-MS/...
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Dried Blood Spot Analysis for Therapeutic Drug Monitoring of Antipsychotics: Drawbacks of Its Clinical Application
Conclusions: The DBS method to quantify risperidone, aripiprazole, pipamperone, and their major metabolites did not meet the acceptance criteria in the Bland–Altman analyses. Therefore, this DBS method was not clinically valid. This study shows the importance of a clinical validation study with use of Bland–Altman plots before clinical implementation. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Development and Validation of a Simultaneous Quantification Method of Ruxolitinib, Vismodegib, Olaparib, and Pazopanib in Human Plasma Using Liquid Chromatography Coupled With Tandem Mass Spectrometry
Conclusions: Using liquid chromatography coupled with tandem mass spectrometry, we have developed and validated a simple and rapid assay for the simultaneous quantification of olaparib, vismodegib, pazopanib, and ruxolitinib in human plasma. This method is now part of our therapeutic drug monitoring service provision and is currently used clinically to manage patients prescribed these drugs. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Measurement of Teicoplanin Concentration With Liquid Chromatography-Tandem Mass Spectrometry Method Demonstrates the Usefulness of Therapeutic Drug Monitoring in Hematologic Patient Populations
Conclusions: Based on these results, the present UHPLC-MS/MS method can be considered suitable for routine TDM of teicoplanin. Also, based on the insufficient trough teicoplanin concentrations achieved with standard dose regimen, and the higher trough teicoplanin concentrations achieved with TDM-guided individualized dose regimen, this study highlights the importance of TDM of teicoplanin, especially in high-risk patient groups. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

The “Ideal” Body Weight for Pediatric Gentamicin Dosing in the Era of Obesity: A Population Pharmacokinetic Analysis
Conclusions: FFM should be used to adjust ABW for empirically dosing gentamicin in pediatric patients aged 2–18 years. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Exploring the Use of C-Reactive Protein to Estimate the Pharmacodynamics of Vancomycin
Background: C-reactive protein (CRP) pharmacodynamic (PD) models have the potential to provide adjunctive methods for predicting the individual exposure response to antimicrobial therapy. We investigated CRP PD linked to a vancomycin pharmacokinetic (PK) model using routinely collected data from noncritical care adults in secondary care. Methods: Patients receiving intermittent intravenous vancomycin therapy in secondary care were identified. A 2-compartment vancomycin PK model was linked to a previously described PD model describing CRP response. PK and PD parameters were estimated using a Non-Parametric Adaptive Gri...
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Effect of Extracorporeal Membrane Oxygenation on the New Vancomycin Dosing Regimen in Critically Ill Patients Receiving Continuous Venovenous Hemofiltration
Conclusions: All patients receiving CVVH achieved the target Ctrough with this new dosing regimen, but those with concurrent ECMO did not. Ctrough must be more closely monitored in patients using ECMO simultaneously. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Phase II Clinical Trial of Lenalidomide and Dexamethasone Therapy in Japanese Elderly Patients With Newly Diagnosed Multiple Myeloma to Determine Optimal Plasma Concentration of Lenalidomide
Conclusions: These data suggest that overexposure to lenalidomide could contribute to toxicity. Furthermore, the predicted cutoff value of AUC0–24 can be clinically used to prevent severe AEs. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Determination of Tacrolimus Concentration and Protein Expression of P-Glycoprotein in Single Human Renal Core Biopsies
Conclusions: These methods may be valuable for the elucidation of the pharmacokinetic mechanisms behind TAC-induced nephrotoxicity in renal transplant recipients. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Pharmacokinetic Therapeutic Drug Monitoring of Advagraf in More Than 500 Adult Renal Transplant Patients, Using an Expert System Online
Background: Immunosuppressant Bayesian dose adjustment (ISBA) is an online expert system, routinely used by approximately 140 transplantation centers in the world for the dose adjustment of immunosuppressive drugs in transplant patients. This system determines the area under the curve (AUC) of the drug by pharmacokinetic modeling and Bayesian estimation. The purpose of this study was to analyze tacrolimus exposure after administration of its modified-release formulation (Advagraf) in kidney allograft recipients, to optimize its therapeutic drug monitoring. Methods: This is a retrospective study of exposure indices mea...
Source: Therapeutic Drug Monitoring - May 11, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance Erratum
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Enhancement and Suppression of Ionization in Drug Analysis Using HPLC-MS/MS in Support of Therapeutic Drug Monitoring: A Review of Current Knowledge of Its Minimization and Assessment Erratum
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Comparison of Biological Screening and Diagnostic Indicators to Detect In Utero Opiate and Cocaine Exposure Among Mother-Infant Dyads: Erratum
No abstract available (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Erratum Source Type: research

Validation of a Reversed-Phase Ultra–High-Performance Liquid Chromatographic Method With Photodiode Array Detection for the Determination of Voriconazole in Human Serum and Its Application to Therapeutic Drug Monitoring
Conclusions: In this study, a reproducible U-HPLC-PDA assay with a short analysis time, requiring only a small amount of serum, good accuracy and reproducibility was validated, which is suitable for routine TDM of voriconazole in serum. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Short Communication Source Type: research

Quantification of Phosphatidylethanols in Whole Blood as a Proxy for Chronic Alcohol Consumption, Using Ultra Performance Convergence Chromatography Tandem Mass Spectrometry
Background: Detection of alcohol consumption after a longer period can be useful in certain patient groups. To monitor chronic alcohol consumption, a novel analytical method for the quantification of phosphatidylethanols (PEths) was developed and validated using ultra performance convergence chromatography–tandem mass spectrometry. Methods: The main phosphatidylethanols like palmitoyl-2-oleoyl-sn-glycero-3-phosphoethanol (POPEth), 1-palmitoyl-2-linoleoyl-sn-glycero-3-phosphoethanol, and 1,2-dioleoyl-sn-glycero-3-phosphoethanol were analyzed using a simple and fast sample preparation protocol followed by chromato...
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Therapeutic Drug Monitoring of Second-Generation Antipsychotics for the Estimation of Early Drug Effect in First-Episode Psychosis: A Cross-sectional Assessment
Conclusions: TDM seems unable to accurately estimate the early effects of SGAs in FEP. Ours is the first study to categorize plasma concentrations of SGAs into ranges for joint processing of data from a larger number of patients. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Prevalence of Therapeutic Drug Monitoring for Lithium and the Impact of Regulatory Warnings: Analysis Using Japanese Claims Database
Conclusions: Results showed that the prevalence of TDM for lithium was low, although TDM for lithium was strongly recommended by the guidelines. Regulatory warnings requiring compliance with the measurement of blood levels during treatment with lithium, issued twice during the five-month period, were associated with an increase in the prevalence of TDM for lithium. However, the impact of the second warning was not remarkable compared with the first warning. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Potential of Oral Fluid as a Clinical Specimen for Compliance Monitoring of Psychopharmacotherapy
Conclusions: Despite a strong statistical correlation between OF and serum concentrations observed for most of the studied substances, it is still evident that OF concentrations cannot simply substitute serum/plasma as therapeutic drug monitoring specimen, but rather be considered as a unique specimen. We believe that OF is a promising matrix especially for compliance testing in psychiatry settings. The Greiner Bio-One device used in this study provides a sampling procedure that offers advantages over the available alternatives. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Quantification of Idelalisib in Human Plasma by Ultra-Performance Liquid Chromatography Coupled to Mass Spectrometry in Negative Ionization Mode
Background: Idelalisib is the first orally active selective phosphatidylinositol 3-kinase delta inhibitor approved by Food and Drug Administration and European Medicines Agency in 2014 for the treatment of several types of blood cancer. Idelalisib is widely used as a monotherapy or in combination with rituximab, bendamustine, or ofatumumab with a significant efficacy. However, idelalisib has shown increased risk of infection and a higher frequency of serious adverse events. It may be useful to determine idelalisib concentration in human plasma to adjust dose and to manage adverse effects in clinical practice. Methods: ...
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Fast and Straightforward Method for the Quantification of Pazopanib in Human Plasma Using LC-MS/MS
Conclusions: In conclusion, the described method was successfully validated and was found to be robust for routine application to analyze samples from cancer patients treated with pazopanib. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Development and Validation of a Bioanalytical Method to Quantitate Enzalutamide and its Active Metabolite N-Desmethylenzalutamide in Human Plasma: Application to Clinical Management of Patients With Metastatic Castration–Resistant Prostate Cancer
Background: Enzalutamide is a potent androgen-signaling receptor inhibitor and is licensed for the treatment of metastatic castration–resistant prostate cancer. N-desmethylenzalutamide is the active metabolite of enzalutamide. A method to quantitate enzalutamide and its active metabolite was developed and validated according to the European Medicine Agency guidelines. Methods: Enzalutamide and N-desmethylenzalutamide were extracted by protein precipitation, separated on a C18 column with gradient elution and analyzed with tandem quadrupole mass spectrometry in positive ion mode. A stable deuterated isotope (D6-e...
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Hospitalized Patients With and Without Hemodialysis Have Markedly Different Vancomycin Pharmacokinetics: A Population Pharmacokinetic Model-Based Analysis
Conclusions: CL and Vc differ markedly between patients undergoing hemodialysis and those not undergoing hemodialysis. Dosing nomogram based on these covariate relationships may potentially help in accurate dosing of vancomycin. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Explaining Interpatient Variability in Adalimumab Pharmacokinetics in Patients With Crohn's Disease
Conclusions: Clearance of ADL increased in the presence of anti-ADL antibodies and was associated with weekly ADL administrations. In clinical practice, the decision to intensify ADL treatment to weekly administrations is primarily based on disease activity. Increased disease activity may be the result of lower drug concentrations due to higher clearance. However, increased disease activity may also increase clearance due to increased target engagement. The causal relationship between these factors remains to be elucidated. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Evaluation of Multiple Linear Regression–Based Limited Sampling Strategies for Enteric-Coated Mycophenolate Sodium in Adult Kidney Transplant Recipients
This study aimed to examine the predictive performance of the published LSS for the estimation of future MPA area under the concentration–time curve from 0 to 12 hours (AUC0–12) in renal transplant recipients. Methods: Total MPA plasma concentrations were measured in 20 adult renal transplant patients on 2 occasions a week apart. All subjects received concomitant tacrolimus and were approximately 1 month after transplant. Samples were taken at 0, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours and 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 9, and 12 hours after dose on the first and second sampling o...
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research

Acute Kidney Injury Biomarkers Predict an Increase in Serum Milrinone Concentration Earlier Than Serum Creatinine–Defined Acute Kidney Injury in Infants After Cardiac Surgery
Conclusions: In this pilot study, urine TIMP-2*IGFBP-7 and KIM-1 were predictive of AKI and excessive milrinone activity. Future studies that include a pharmacodynamics assessment of patient hemodynamics, excessive milrinone activity, and AKI biomarker concentrations may be warranted to integrate this concept into clinical practice. (Source: Therapeutic Drug Monitoring)
Source: Therapeutic Drug Monitoring - March 13, 2018 Category: Drugs & Pharmacology Tags: Original Article Source Type: research