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Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

Articoli con TAG: TDM

Carbamazepine and Carbamazepine-10,11-epoxide measurement with the reference LC-MS/MS method and a routine immunoassay
Carbamazepine and Carbamazepine-10,11-epoxide measurement with the reference LC-MS/MS method and a routine immunoassay
<p>Introduction: Carbamazepine is a common antiepileptic drug used for treatment of epilepsy and other neurologic conditions. Carbamazepine-10,11-epoxide, one of its metabolites, is pharmacologically active and its values increase with concomitant use of other anticonvulsants. This study is aimed to compare the method used in our routine laboratory with a reference LC-MS/MS method for monitoring Carbamazepine, and to compare the concentrations of the drug to one of its metabolites. Methods: plasma samples were collected from patients for whom Carbamazepine measurement had been requested. For each plasma sample, Carbamazepine was assayed on Roche Cobas with Cobas CARB4 kit (immunoassay). Carbamazepine and Carbamazepine-10,11-epoxide determination were then performed with a validated and verified LC-MS/MS technique. Results: the study population consisted of 30 subjects. No significant differences were found between the routine immunoassay and the LC-MS/MS technique using Passing-Bablok regression and Bland-Altman graph, whilst the concentrations of plasma Carbamazepine and its epoxide measured with LC-MS/MS displayed a very modest correlation (r=0.639). The ratio calculated between Carbamazepine and its epoxide displayed a broad range of values (3.37-12.55). Discussion: considering the clinical significance of Carbamazepine measurement as part of TDM, we confirmed the validity of our routinely used immunoassay as easier and faster alternative to the reference method for routine quantification of plasma Carbamazepine concentration. Considering that levels of the epoxide are unpredictable and independent from the parent drug concentrations, a more comprehensive assessment of Carbamazepine metabolites should be considered, especially when patients have uncontrolled symptoms or display challenging dose adjustment.</p>
Biochimica Clinica ; 46(2) 117-121
Contributi Scientifici - Scientific Papers
Indicazioni per l’armonizzazione dell’intervallo terapeutico nel monitoraggio plasmatico dei farmaci antiretrovirali
Indications for the harmonization of the plasma therapeutic ranges in the antiretroviral drugs monitoring
Biochimica Clinica ; 46(3) 247-254
Documenti - Documents
Indicazioni per l’armonizzazione degli intervalli terapeutici dei farmaci antibatterici
Indications for the harmonization of the therapeutic intervals of antibacterial drugs.
<p>In the last years infections due to multi-drug resistant Gram-positive and Gram-negative bacteria have increased. The accurate measurement of plasma concentrations of antibacterial drugs is crucial to identify antimicrobial therapies based on pharmacokinetics/pharmacodynamics (PK/PD) strategies. The aim of this paper is to provide an overview of the currently available information on PK/PD, minimal inhibitory concentration (MIC) and their relationships, for optimal antibacterial treatment in daily practice. Relevant papers reporting PK/PD data on different antibiotics, administered intravenously for the treatment of infections due to bacteria with reduced sensitivity or overt resistance to antibiotics, have been retrieved from the PubMed database. The classes of drugs considered were: beta-lactams, aminoglycosides, glycopeptides, lipopeptides, fluoroquinolones, tetracyclines, polymyxins and oxazolidinones. A short summary was prepared for each class of drugs and for specific drugs as well, including data on the mechanism of action, spectrum of activity and resistance, PK/PD index and target values related to MIC.&nbsp;</p>
Biochimica Clinica ; 46(4) 347
Documenti - Documents
Approccio combinato tra il monitoraggio terapeutico del farmaco (TDM) e farmacogenetica per l’applicazione della medicina personalizzata nella pratica clinica
Combined approach of TDM and pharmacogenetics for application of personalized medicine in the clinical practice
<p>&nbsp;</p><p>&nbsp;<span style="font-size:9.0pt">Therapeutic Drug Monitoring (TDM) can be defined as the assessing of the adequacy of the drug plasma concentrations to a target concentration or to a concentration window at a specific time in a dosing interval. Following appropriate clinical interpretation and according to the drug pharmacokinetic/pharmacodynamic (PK/PD) properties, this evaluation can guide dosing optimization. However, finding the optimal dosing in order to guarantee a therapeutic exposure remains complicated. Sources of PK variability, including age, genetic heritage, and disease conditions, influence the chances of achieving adequate therapeutic outcomes. Another important aspect related to drug efficacy and safety is the Pharmacogenetics (PGx). Genetic variants or single nucleotide polymorphisms (SNPs) in genes encoding for metabolizing enzymes and membrane carriers, may affect drug response and/or toxicity. A combination of TDM and PGx could represent a personalized approach in clinical practice especially for off-label drugs used in polytherapy and characterized by a narrow therapeutic index. TDM combined to PGx represents an useful tool that could help clinicians in tailoring pharmacological therapies. We present here three case reports related to pediatric patients who have shown adverse drug reactions in response to therapies with phenytoin (PHT), voriconazole (VO) and isoniazid (INH).</span></p>
Biochimica Clinica ; 46(4) e31
Casi Clinici - Case Report
Passaggio di venlafaxina nel latte materno durante l’allattamento: rilevanza della sua misura in laboratorio
Venlafaxine excretion in breast milk during 12-months of lactation: the relevance of the laboratory measurement
<p>&nbsp;A woman with pre-existing depression on treatment with venlafaxine at 75 mg daily underwent a caesarean section due to alteration of the cardiotocography trace. No sign of poor neonatal adaption was observed in the newborn due to the antidepressant exposition. The mother was suggested to breast feed the baby and continue with the antidepressant therapy. Drug concentrations of venlafaxine in mother and neonate plasma and in mother milk at birth and during follow up visits were determined. A significant reduction in the plasma venlafaxine concentrations from the mother was observed at birth compared with the 3rd trimester (77 versus 245 ng/mL), with a full recovery at month 2 after delivery (226 ng/mL). Plasma venlafaxine concentrations from the newborn were high at birth (185 ng/mL) and progressively declined with time, despite the high milk drug concentrations measured throughout the observational period. During the one-year follow-up, no symptoms related to venlafaxine-toxicity were observed in the baby-girl.</p>
Biochimica Clinica ; 46(3) S134-S136
Casi Clinici - Case Report
Importanza del monitoraggio terapeutico dei farmaci durante la gravidanza in una donna con infezione da HIV di lunga durata in trattamento farmacologico multiplo
The importance of Therapeutic Drug Monitoring during pregnancy in a HIV-positive woman taking lifelong antiretroviral therapy.
<p><span style="font-size:9pt">Providing antiretroviral (ARV) therapy to achieve or maintain complete HIV viral replication control during pregnancy is fundamental to prevent mother-to-child-transmission. We describe the case of a woman, HIV positive since birth with multiple drug resistance to HIV drugs due to poor life-long adherence to ARV. Once pregnant, the woman showed massive viral replication during last days of the third trimester of pregnancy after previous viral undetectability. Given drug resistance profile and pregnancy pharmacokinetic changes, therapy choice was limited to a complex 5-7 tablets daily regimen of drugs with potential gastrointestinal side effects (i.e. nausea or vomiting). Therapeutic drug monitoring (TDM) revealed sub-optimal ARV exposure potentially related to a selective non-adherence to therapy due to difficult swallowing and vomiting. Therapy was modified based on TDM aiming at a rapid HIV viral load decrease in the last days before planned cesarean delivery. The newborn was healthy and negative for HIV RNA at delivery and during follow-up.</span></p>
Biochimica Clinica ; 46(3) S137-140
Casi Clinici - Case Report