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Pharmaceutics
Special Issues
Innovative Tools for Therapeutic Drug Monitoring, 2nd Edition
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Innovative Tools for Therapeutic Drug Monitoring, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".

Deadline for manuscript submissions: closed (30 November 2023) | Viewed by 2866

Special Issue Editor

Prof. Dr. Zoubir Djerada

E-Mail Website
Guest Editor
Department of Pharmacology and Toxicology, Université de Reims Champagne-Ardenne, HERVI, CHU Reims, 51100 Reims, France
Interests: pharmacology and pharmacokinetic-pharmacodynamic modelling; therapeutic drug monitoring; clinical research methodology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The variability of drug response complicates the prediction of the risk–benefit balance, limiting the real benefit of a treatment. The pharmacometrics approach provides an attractive solution to characterize the variability of response to drugs and identify the clinical and biological parameters for therapeutic drug monitoring.

If this variability is considered, a priori adaptation can be proposed. A more precise a posteriori optimization can also be made when integrating drug concentrations and metabolites in biological matrices, combined, if necessary, with pharmacogenetic data. The integration of clinical data (patient characteristics, clinical response, undesirable effects, toxic effects) finally makes it possible to propose a more rational individualization.

Pharmacological therapeutic monitoring aims to satisfy this need to adapt treatments to each clinical situation.

This Special Issue provides a panorama of state-of-the-art therapeutic drug monitoring and its tools. Examples of modern approaches to adapting dosages for different pharmacological classes in different medical specialties and situations such as anesthesia, infection, psychiatry, neurology, cardiology, oncology, intensive care medicine, nephrology, chronic inflammatory diseases, etc., are also welcome.

Prof. Dr. Zoubir Djerada
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • therapeutic drug
  • monitoring pharmacokinetic/pharmacodynamic modeling
  • bayesian therapeutic drug monitoring
  • biomarkers
  • bioanalysis

Related Special Issue

Published Papers (2 papers)

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Research

17 pages, 1652 KiB  
Article
Validation of Liquid Chromatography Coupled with Tandem Mass Spectrometry for the Determination of 12 Tyrosine Kinase Inhibitors (TKIs) and Their Application to Therapeutic Drug Monitoring in Adult and Pediatric Populations
by Marie Bellouard, Jean Donadieu, Pauline Thiebot, Etienne Giroux Leprieur, Philippe Saiag, Isabelle Etting, Pamela Dugues, Emuri Abe, Jean-Claude Alvarez and Islam-Amine Larabi
Pharmaceutics 2024, 16(1), 5; https://doi.org/10.3390/pharmaceutics16010005 - 19 Dec 2023
Viewed by 1012
Abstract
Tyrosine kinase inhibitors (TKIs) are used as targeted cancer therapies in adults and have an off-label pediatric application for the treatment of Langerhans cell histiocytosis. A multitarget LC-MS/MS method was developed and validated for the determination of alectinib, alectinib-M4, binimetinib, cobimetinib, crizotinib, dabrafenib, [...] Read more.
Tyrosine kinase inhibitors (TKIs) are used as targeted cancer therapies in adults and have an off-label pediatric application for the treatment of Langerhans cell histiocytosis. A multitarget LC-MS/MS method was developed and validated for the determination of alectinib, alectinib-M4, binimetinib, cobimetinib, crizotinib, dabrafenib, encorafenib, imatinib, lorlatinib, osimertinib, AZ5104, and trametinib. A total of 150 µL of internal standard methanolic solution was added to 50 µL of plasma sample to precipitate proteins. After centrifugation, 10 µL of the supernatant was injected into the chromatographic system. The chromatographic separation was conducted on a Kinetex C18 Polar column with a gradient of 2 mM ammonium formate in 0.1% formic acid and acetonitrile over 5 min. Limits of detection and quantification, linearity, accuracy, precision, selectivity, carryover, matrix effect, recovery, and stability were evaluated and satisfied EMA guidelines on bioanalytical methods. This method has been successfully applied to the therapeutic drug monitoring (TDM) of adults with melanoma and lung cancer, as well as children with histiocytosis, to improve the pharmacokinetic data for these drugs, with the aim of enhancing the therapeutic management and follow-up of patients. Blood concentrations of trametinib and binimetinib were different in the two groups, highlighting the age-related inter-individual variability of these molecules and the need for TDM. Full article
(This article belongs to the Special Issue Innovative Tools for Therapeutic Drug Monitoring, 2nd Edition)
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22 pages, 1686 KiB  
Article
LC-MS/MS Method for the Quantification of PARP Inhibitors Olaparib, Rucaparib and Niraparib in Human Plasma and Dried Blood Spot: Development, Validation and Clinical Validation for Therapeutic Drug Monitoring
by Giovanni Canil, Marco Orleni, Bianca Posocco, Sara Gagno, Alessia Bignucolo, Marcella Montico, Rossana Roncato, Serena Corsetti, Michele Bartoletti and Giuseppe Toffoli
Pharmaceutics 2023, 15(5), 1524; https://doi.org/10.3390/pharmaceutics15051524 - 18 May 2023
Cited by 2 | Viewed by 1502
Abstract
Poly (ADP-ribose) polymerase inhibitors (PARPis) are becoming increasingly meaningful in oncology, and their therapeutic drug monitoring (TDM) might be beneficial for patients. Several bioanalytical methods have been reported for PARPis quantification in human plasma, but advantages might be obtained using dried blood spot [...] Read more.
Poly (ADP-ribose) polymerase inhibitors (PARPis) are becoming increasingly meaningful in oncology, and their therapeutic drug monitoring (TDM) might be beneficial for patients. Several bioanalytical methods have been reported for PARPis quantification in human plasma, but advantages might be obtained using dried blood spot (DBS) as a sampling technique. Our aim was to develop and validate a liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for olaparib, rucaparib, and niraparib quantification in both human plasma and DBS matrices. Additionally, we aimed to assess the correlation between the drug concentrations measured in these two matrices. DBS from patients was obtained using Hemaxis DB10 for volumetric sampling. Analytes were separated on a Cortecs-T3 column and detected with electrospray ionization (ESI)-MS in positive ionization mode. Validation was performed according to the latest regulatory guidelines, in the range (ng/mL) 140–7000 for olaparib, 100–5000 for rucaparib, and 60–3000 for niraparib, within the hematocrit (Hct) range 29–45%. The Passing–Bablok and Bland–Altman statistical analyses revealed a strong correlation between plasma and DBS for olaparib and niraparib. However, due to the limited amount of data, it was challenging to establish a robust regression analysis for rucaparib. To ensure a more reliable assessment, additional samples are required. The DBS-to-plasma ratio was used as a conversion factor (CF) without considering any patient-related hematological parameters. These results provide a solid basis for the feasibility of PARPis TDM using both plasma and DBS matrices. Full article
(This article belongs to the Special Issue Innovative Tools for Therapeutic Drug Monitoring, 2nd Edition)
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