A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.


BACKGROUND:Solithromycin is a fourth-generation macrolide antibiotic with potential efficacy in pediatric community-acquired bacterial pneumonia. Pharmacokinetic (PK) studies of solithromycin in pediatric subjects are limited, therefore application of minimally invasive drug sampling techniques, such as dried blood spots (DBS), may enhance the enrollment of children in PK studies. The objectives of this study were to compare solithromycin concentrations in DBS with those in liquid plasma samples (LPS) and to quantify the effects of modeling DBS concentrations on the results of a population PK model. METHODS:Comparability analysis was performed on matched DBS and LPS solithromycin concentrations collected from two different phase 1 clinical trials of solithromycin treatment in children (clinicaltrials.gov #NCT01966055 and #NCT02268279). Comparability of solithromycin concentrations was evaluated based on DBS:LPS ratio, median percentage prediction error, and median absolute percentage prediction error. The effect of correcting DBS concentrations for both hematocrit and protein binding was investigated. In addition, a previously published population PK model (NONMEM) was leveraged to compare parameter estimates resulting from either DBS or LPS concentrations. RESULTS:A total of 672 paired DBS-LPS concentrations were available from 95 subjects (age: 0-17 years of age). The median (range) LPS and DBS solithromycin concentrations were 0.3 (0.01-12) mcg/mL and 0.32 (0.01-14) mcg/mL, respectively. Median percentage prediction error and median absolute percentage prediction error of raw DBS to LPS solithromycin concentrations were 5.26% and 22.95%, respectively. In addition, the majority of population PK parameter estimates resulting from modeling DBS concentrations were within 15% of those obtained from modeling LPS concentrations. CONCLUSIONS:Solithromycin concentrations in DBS were similar to those measured in LPS and did not require correction for hematocrit or protein binding.


Ther Drug Monit


Beechinor RJ,Cohen-Wolkowiez M,Jasion T,Hornik CP,Lang JE,Hernandez R,Gonzalez D




Has Abstract


2019-12-01 00:00:00












  • Population pharmacokinetics of lamotrigine with data from therapeutic drug monitoring in German and Spanish patients with epilepsy.

    abstract::This study develops a population pharmacokinetic model for lamotrigine (LTG) in Spanish and German patients diagnosed with epilepsy. LTG steady-state plasma concentration data from therapeutic drug monitoring were collected retrospectively from 600 patients, with a total of 1699 plasma drug concentrations. The data we...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Rivas N,Buelga DS,Elger CE,Santos-Borbujo J,Otero MJ,Domínguez-Gil A,García MJ

    更新日期:2008-08-01 00:00:00

  • The relationship between the response of clinical symptoms and plasma olanzapine concentration, based on pharmacogenetics: Juntendo University Schizophrenia Projects (JUSP).

    abstract::The monitoring of plasma olanzapine concentrations has been found to be an important and useful tool for optimizing psychiatric treatment. The present study investigated the effect that clinical factors, such as smoking and age, and functional polymorphisms of UGT1A4, CYP1A2, and CYP2D6 genes have on plasma olanzapine...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Nozawa M,Ohnuma T,Matsubara Y,Sakai Y,Hatano T,Hanzawa R,Shibata N,Arai H

    更新日期:2008-02-01 00:00:00

  • Experience with a computer-based technique for estimating pharmacokinetic constants from limited data.

    abstract::A computer-based approach for estimating pharmacokinetic data and predicting plasma drug concentrations based on two measurements of plasma drug concentrations was compared with a standard two-point method for estimating aminoglycoside (AG) pharmacokinetic parameters. The computer-based technique was also used to pred...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Bachmann K,Pongsin V,Forney R Jr,Gronau G

    更新日期:1985-01-01 00:00:00

  • Efficacy of low-dose boosted saquinavir once daily plus nucleoside reverse transcriptase inhibitors in pregnant HIV-1-infected women with a therapeutic drug monitoring strategy.

    abstract::The efficacy of low-dose, ritonavir-boosted saquinavir (SQV/rtv) once daily plus 2 nucleoside retrotranscriptase inhibitors (NRTIs) in pregnant human immunodeficiency virus (HIV)-1-infected women was prospectively evaluated, ensuring a SQV minimum concentration (Cmin) >/=100 ng/mL with a therapeutic drug monitoring st...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,多中心研究


    authors: Lopez-Cortes LF,Ruiz-Valderas R,Rivero A,Camacho A,Marquez-Solero M,Santos J,García-Lazaro M,Viciana P,Rodriguez-Baños J,Ocampo A

    更新日期:2007-04-01 00:00:00

  • Analysis of isepamicin in human plasma by radioimmunoassay, microbiologic assay, and high-performance liquid chromatography.

    abstract::Plasma concentrations of isepamicin, a new aminoglycoside antibiotic, were determined by radioimmunoassay (RIA), microbiological assay (MA), and high-performance liquid chromatography (HPLC) in healthy volunteers after administration of 7.5 mg/kg intramuscular dosages once daily for 10 days. Plasma samples were collec...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Lin CC,Veals J,Korduba C,Hilbert MJ,Nomeir A

    更新日期:1997-12-01 00:00:00

  • Ultra fast liquid chromatography-tandem mass spectrometry routine method for simultaneous determination of cyclosporin A, tacrolimus, sirolimus, and everolimus in whole blood using deuterated internal standards for cyclosporin A and everolimus.

    abstract::Specific chromatographic methods for the measurement of cyclosporin A, tacrolimus, sirolimus, and everolimus blood levels in patients with organ transplants are time consuming when large numbers of samples must be processed. The authors developed a robust and fast (1 minute) online solid-phase extraction liquid chroma...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Meinitzer A,Gartner G,Pilz S,Stettin M

    更新日期:2010-02-01 00:00:00

  • Clinician ordering practices for voriconazole therapeutic drug monitoring: experiences of a referral laboratory.

    abstract::Monitoring of serum voriconazole concentrations has been proposed to optimize therapeutic effect and minimize toxicity. However, little is known about the clinical use of voriconazole therapeutic drug monitoring (TDM) by treating physicians. Four hundred seventy-eight episodes corresponding with 161 adult patients (me...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Miyakis S,van Hal SJ,Solvag CJ,Ray J,Marriott D

    更新日期:2010-10-01 00:00:00

  • The evolution of therapeutic immunosuppression and the potential impact of drug concentration monitoring.

    abstract::The major goal of immunosuppressive development is improved selectivity of the drug's inhibitory action against T and B cell-mediated as opposed to nonspecific granulocyte-, monocyte-, and macrophage-mediated resistance. This enterprise demands increased knowledge of alloantigen-induced stimulation, signal transductio...

    journal_title:Therapeutic drug monitoring

    pub_type: 历史文章,杂志文章


    authors: Kahan BD

    更新日期:1995-12-01 00:00:00

  • Haloperidol plasma level monitoring in pediatric patients.

    abstract::Plasma levels of haloperidol were monitored in children and teenagers suffering from psychotic episodes and/or abnormal movements (tics and Gilles de la Tourette's syndrome). Steady-state concentrations of haloperidol ranged from 0.7 to 19 ng/ml without any apparent relationship with the administered dose (15--285 mic...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Morselli PL,Bianchetti G,Durand G,Le Heuzey MF,Zarifian E,Dugas M

    更新日期:1979-01-01 00:00:00

  • Toxicology Screening Testing in Patients Undergoing Spine Surgery: A Prospective Observational Pilot Study.

    abstract:BACKGROUND:Chronic opioid use and polypharmacy are commonly seen in chronic pain patients presenting for spine procedures. Substance abuse and misuse have also been reported in this patient population. Negative perioperative effects have been found in patients exposed to chronic opioid, alcohol, and recreational substa...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Clavijo CF,Oliva AM,Dingmann C,Kaizer A,Christians U,Burger E,Patel V,Kleck CJ,Vogel SA,Scott BK,Janik DJ,Jameson LC,Ginde AA

    更新日期:2021-02-01 00:00:00

  • A simple method to calculate cyclosporine dosage to obtain a target C2 drug level.

    abstract::C(2) Cyclosporine (CsA) level, as a surrogate of area under the time-concentration curve (AUC) 0-4 hours, is a good predictor of drug absorption and clinical outcome after kidney transplantation. It has been difficult to define the optimal C(2) level in the individual case and given the broad range of C(2) due to inte...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Morales J,Buckel E,Fierro A,Zehnder C,Herzog C,Mañalich J

    更新日期:2003-06-01 00:00:00

  • Hair analysis of fatty acid ethyl esters in the detection of excessive drinking in the context of fetal alcohol spectrum disorders.

    abstract::A serious challenge in diagnosing fetal alcohol spectrum disorder (FASD) is the need to document alcohol use during pregnancy. Maternal/paternal alcohol abuse affects the likelihood of fetal alcohol exposure, and hence the occurrence of FASD. The objective of the current study was to document the use of the fatty acid...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Kulaga V,Pragst F,Fulga N,Koren G

    更新日期:2009-04-01 00:00:00

  • Analytic aspects of cyclosporine monitoring, on behalf of the IFCC/IATDMCT Joint Working Group.

    abstract::The use of therapeutic drug monitoring strategies for cyclosporin (CsA) has evolved markedly in recent years since previous consensus guidelines were presented. Apart from the introduction of some new methods, the major change has been the shift away from the traditional predose/trough (C0) sample. The most popular al...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Morris RG,Holt DW,Armstrong VW,Griesmacher A,Napoli KL,Shaw LM,IFCC\/IATDMCT Joint Working Group.

    更新日期:2004-04-01 00:00:00

  • A high-performance liquid chromatography-mass spectrometry method using a novel atmospheric pressure chemical ionization approach for the rapid simultaneous measurement of tacrolimus and cyclosporin in whole blood.

    abstract::Concentration monitoring and dose individualization is required to optimize either tacrolimus or cyclosporin therapy. In this study, the validation of a simple, rapid high-performance liquid chromatography-tandem mass spectrometry method for the simultaneous measurement of tacrolimus and cyclosporin in whole blood is ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Salm P,Taylor PJ,Rooney F

    更新日期:2008-06-01 00:00:00

  • Analytical Validation and Cross-Validation of an NFAT-Regulated Gene Expression Assay for Pharmacodynamic Monitoring of Therapy With Calcineurin Inhibitors.

    abstract:BACKGROUND:Analysis of residual gene expression of the nuclear factor of activated T cell (NFAT)-regulated genes has been developed as a pharmacodynamic biomarker to monitor therapy with calcineurin inhibitors. The availability of commercial primer sets (Search-LC) and the well-established assay protocol makes this bio...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Abdel-Kahaar E,Giese T,Sommerer C,Rieger H,Shipkova M,Wieland E

    更新日期:2016-12-01 00:00:00

  • Antiretrovirals: simultaneous determination of five protease inhibitors and three nonnucleoside transcriptase inhibitors in human plasma by a rapid high-performance liquid chromatography--mass spectrometry assay.

    abstract::An analytical technique using liquid chromatography (LC) coupled with electrospray-mass spectrometry (ESI--MS) has been developed for the simultaneous determination of five protease inhibitors (PIs): saquinavir, indinavir, ritonavir, nelfinavir, and amprenavir; and three non-nucleoside reverse transcriptase inhibitors...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Villani P,Feroggio M,Gianelli L,Bartoli A,Montagna M,Maserati R,Regazzi MB

    更新日期:2001-08-01 00:00:00

  • South Africa: a toxicologist's goldmine.

    abstract::The emerging nation of South Africa, in common with some other countries, notably Eastern Europe, is heir to decades of neglect with regards to the exposure of the majority of its population to toxic materials. In this short review, the major toxic health hazards are described. For most of these risks there are now pr...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Stewart MJ

    更新日期:2002-02-01 00:00:00

  • Aluminum toxicity in patients with chronic renal failure.

    abstract::During the past two decades, in association with the commencement of chronic dialysis therapy and prolongation of the uremic state, aluminum toxicity has represented a major cause of morbidity and mortality in uremic patients. The uremic patient has been found to be at higher risk of aluminum loading and toxicity from...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Alfrey AC

    更新日期:1993-12-01 00:00:00

  • Impact of active metabolites on monitoring plasma concentrations of therapeutic drugs.

    abstract::Monitoring plasma concentrations of therapeutic drugs presents special problems when these drugs are metabolized to compounds that have pharmacologic activity. This presentation reviews several methods for evaluating the pharmacologic activity of drug metabolites and describes the impact of active drug metabolites on ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Atkinson AJ Jr,Stec GP,Lertora JJ,Ruo TI,Thenot JP

    更新日期:1980-01-01 00:00:00

  • The pharmacokinetics of enteric-coated mycophenolate sodium and its gastrointestinal side effects in de novo renal transplant recipients of Hispanic ethnicity.

    abstract:OBJECTIVE:The aim of the study is to characterize the pharmacokinetics and the gastrointestinal side effect profiles of enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant patients of Hispanic ethnicity. MATERIALS AND METHODS:The pharmacokinetic study of EC-MPS was conducted in 11 de novo kidney ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Shah T,Tellez-Corrales E,Yang JW,Qazi Y,Wang J,Wilson J,Hutchinson I,Min DI

    更新日期:2011-02-01 00:00:00

  • Ability of a first-pass pharmacokinetic model to characterize cyclosporine blood concentrations after administrations of Sandimmune or Neoral formulations.

    abstract::Most recent cyclosporine (CsA) pharmacokinetic (PK) studies have focused on noncompartmental analysis. Because CsA undergoes significant first-pass elimination after oral dosing, the most appropriate compartment model may need to take this process into account for the construction of a valid population PK model for Sa...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Ducharme MP,Verret L,Brouillette D,Sirois G

    更新日期:1998-04-01 00:00:00

  • Monitoring of plasma methadone: intercorrelation between immunoassay and gas chromatography-mass spectrometry.

    abstract::Determination of plasma methadone is essential in connection with dose adjustments for patients participating in methadone maintenance programs. We successfully adapted the existing fluorescence polarization immunoassay (FPIA) kit intended for urinary methadone to plasma assays. A concentration interval of 50-900 ng/m...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Beck O,Boreus LO,Borg S,Jacobsson G,Lafolie P,Stensiö M

    更新日期:1990-09-01 00:00:00

  • High single dose of mitoxantrone and cytarabine in acute non-lymphocytic leukemia: a pharmacokinetic and clinical study.

    abstract::In a phase I-II study, the authors evaluated the intracellular pharmacokinetics, toxicity, and efficiency of a high dose of mitoxantrone given as first induction in acute non-lymphocytic leukemia. Twenty-two patients with previously untreated de novo ANLL were included and received 30 or 40 mg/m2 mitoxantrone on day 1...

    journal_title:Therapeutic drug monitoring

    pub_type: 临床试验,杂志文章


    authors: Möllgård L,Tidefelt U,Sundman-Engberg B,Löfgren C,Lehman S,Paul C

    更新日期:1998-12-01 00:00:00

  • A population pharmacokinetic model of gabapentin developed in nonparametric adaptive grid and nonlinear mixed effects modeling.

    abstract::Gabapentin is used in analgesic treatment of neuropathic pain, and large interindividual variation has been observed in the pharmacokinetics (PK) of the drug. The aim of this study was to develop a population PK model for gabapentin appropriate for monitoring patients with neuropathic pain and for individualizing thei...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Carlsson KC,van de Schootbrugge M,Eriksen HO,Moberg ER,Karlsson MO,Hoem NO

    更新日期:2009-02-01 00:00:00

  • Evaluation of an enzyme immunochromatography method for carbamazepine: a comparison with enzyme-multiplied immunoassay technique, fluorescence polarization immunoassay, and high-performance liquid chromatography.

    abstract::A noninstrumented enzyme immunochromatography (EIC) method for monitoring carbamazepine using whole blood was compared to the enzyme-multiplied immunoassay technique (EMIT), fluorescence polarization immunoassay (FPIA), and high-performance liquid chromatography (HPLC). Samples from 74 patients were evaluated in the c...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Oles KS,Penry JK,Dyer RD

    更新日期:1989-01-01 00:00:00

  • Optimum dosage regimen of palivizumab?

    abstract::Palivizumab is a humanized, monoclonal antibody used to protect at-risk infants against respiratory syncytial virus (RSV) infection. The regular dosage scheme causes a low initial trough level and accumulation of the antibody after subsequent injections. Using a simple pharmacokinetic model, the authors devised an alt...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Zaaijer HL,Vandenbroucke-Grauls CM,Franssen EJ

    更新日期:2002-06-01 00:00:00

  • The aminoglycoside panel: a new approach to monitoring aminoglycoside therapy.

    abstract::The aminoglycoside antibiotics gentamicin and tobramycin have been monitored traditionally by measuring peak and trough drug levels in serum. We found interpretation of these data to be hazardous, due to variations in the drug administration-specimen collection process and routine medical events and practices. We desc...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Gorsky JE,Latts JR

    更新日期:1983-06-01 00:00:00

  • Old and new antirheumatic drugs and the risk of hepatotoxicity.

    abstract::Given the high prevalence of the use of medications in daily practice and the large number of people taking antirheumatic agents, the risk of drug-drug interactions and of hepatotoxicity is of concern. Both old and new compounds show such a risk. Nonsteroidal antinflammatory drugs are widely used drugs with potential ...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章,评审


    authors: Anelli MG,Scioscia C,Grattagliano I,Lapadula G

    更新日期:2012-12-01 00:00:00

  • Binding parameters of valproic acid to serum protein in healthy adults at steady state.

    abstract::Two hundred milligrams of valproic acid (VPA) was administered orally to seven healthy adults at 9:00 and 21:00 h for 5 consecutive days, including the morning dose on day 6. On the sixth day, blood samples were drawn at 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 3, and 6 h after the morning dose. Binding of VPA to serum prote...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Kodama Y,Koike Y,Kimoto H,Yasunaga F,Takeyama M,Teraoka I,Fujii I

    更新日期:1992-02-01 00:00:00

  • Simultaneous quantification of levetiracetam and gabapentin in plasma by ultra-pressure liquid chromatography coupled with tandem mass spectrometry detection.

    abstract:INTRODUCTION:Gabapentin (Neurontin) and levetiracetam (Keppra) are anticonvulsants with novel structures and suggested therapeutic ranges of 2-10 mg/L and 6-20 mg/L, respectively. Gabapentin is also used extensively to manage neuropathic pain, and for this indication, wherein higher doses are prescribed, plasma concent...

    journal_title:Therapeutic drug monitoring

    pub_type: 杂志文章


    authors: Juenke JM,Brown PI,Johnson-Davis KL,McMillin GA

    更新日期:2011-04-01 00:00:00