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Pharmaceutics
Special Issues
Optimizing Drug Safety and Efficacy: Pharmacokinetic Modeling
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Optimizing Drug Safety and Efficacy: Pharmacokinetic Modeling

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

Deadline for manuscript submissions: 30 June 2024 | Viewed by 2593

Special Issue Editors

Dr. Brian Cicali

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Guest Editor
Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL 32827, USA
Interests: pharmacokinetics; drug safety; drug efficacy; pharmacokinetic modeling; pharmacogenetics; clinical pharmacology
Dr. Francine Johansson Azeredo

E-Mail Website
Guest Editor
Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL 32827, USA
Interests: pharmacokinetics/pharmacodynamics modeling; microdialysis; pharmacokinetic evaluation; anti-infective drugs

Special Issue Information

Dear Colleagues,

Pharmacokinetics is the study of what the body does to a drug after administration, and is critical for understanding how much of the drug a patient will be exposed to and for how long. This information is important for maintaining doses that are both safe and efficacious based on a particular drug’s profile. Furthermore, special considerations need to be made for drug pharmacokinetic evaluations for patients with varying intrinsic and extrinsic properties, such as enzyme expression differences, renal or hepatic deficiencies, drug–drug interactions, and age-based changes, among others. To address this important aspect of drug development and utility, many modeling methods are available for evaluating the processes involved in drug pharmacokinetics and how to optimize drug safety and efficacy based on physiologic and pharmacokinetic principles. 

This Special Issue will cover various pharmacokinetic modeling methods and applications utilized for the evaluation of drug safety and efficacy, specifically focusing on how pharmacokinetic modeling can be used to ensure optimal drug safety and efficacy among various clinical scenarios.

Dr. Brian Cicali
Dr. Francine Johansson Azeredo
Guest Editors

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

  • pharmacokinetics
  • drug safety
  • drug efficacy
  • population pharmacokinetic modeling
  • physiologically based pharmacokinetic modeling
  • special populations
  • pharmacogenetics
  • personalized medicine

Published Papers (2 papers)

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Research

14 pages, 1298 KiB  
Article
Population Pharmacokinetic Model of Linezolid and Probability of Target Attainment in Patients with COVID-19-Associated Acute Respiratory Distress Syndrome on Veno-Venous Extracorporeal Membrane Oxygenation—A Step toward Correct Dosing
by Dragana Milaković, Tijana Kovačević, Pedja Kovačević, Vedrana Barišić, Sanja Avram, Saša Dragić, Biljana Zlojutro, Danica Momčičević, Branislava Miljković and Katarina Vučićević
Pharmaceutics 2024, 16(2), 253; https://doi.org/10.3390/pharmaceutics16020253 - 8 Feb 2024
Viewed by 1230
Abstract
During veno-venous extracorporeal membrane oxygenation (vv ECMO) therapy, antimicrobial drugs are frequently used, and appropriate dosing is challenging due to there being limited data to support the dosage. Linezolid is effective against multidrug-resistant Gram-positive pathogens frequently isolated in ECMO patients. In total, 53 [...] Read more.
During veno-venous extracorporeal membrane oxygenation (vv ECMO) therapy, antimicrobial drugs are frequently used, and appropriate dosing is challenging due to there being limited data to support the dosage. Linezolid is effective against multidrug-resistant Gram-positive pathogens frequently isolated in ECMO patients. In total, 53 steady-state linezolid levels were obtained following 600 mg intravenous (IV) injections every 8 h, and these were used to develop a population pharmacokinetic (PopPK) model in patients with COVID-19-associated acute respiratory distress syndrome (CARDS) on vv ECMO. The data were analyzed using a nonlinear mixed-effects modelling approach. Monte Carlo simulation generated 5000 patients’ individual PK parameters and corresponding concentration–time profiles using the PopPK model, following the administration of 600 mg/8 h (a higher-than-standard dosing) and 600 mg/12 h (standard). The probabilities of pharmacokinetic/pharmacodynamic (PK/PD) target attainment (PTA) and the cumulative fraction of responses (CFR) for three pathogens were calculated and compared between the two dosing scenarios. Linezolid 600 mg/8 h was predicted to achieve greater than or equal to 85%Tf>MIC in at least 90% of the patients with CARDS on vv ECMO compared to only approximately two thirds of the patients after dosing every 12 h at a minimal inhibitory concentration (MIC) of 2 mg/L. In addition, for the same MIC, fAUC24/MIC ≥ 80 was achieved in almost three times the number of patients following an 8-h versus a 12-h interval. PopPK simulation predicted that a significantly higher proportion of the patients with CARDS on vv ECMO would achieve the PK/PD targets following the 8-h dosing interval compared to standard linezolid dosing. Nevertheless, the safety concern, in particular, for thrombocytopenia, with higher-than-standard linezolid dosage is reasonable, and consequently, monitoring is essential. Full article
(This article belongs to the Special Issue Optimizing Drug Safety and Efficacy: Pharmacokinetic Modeling)
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14 pages, 1949 KiB  
Article
Body Surface Area-Based Dosing of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplant Recipients: A Prospective Population Pharmacokinetic Study
by Hyun Jin Park, Kyung Taek Hong, Nayoung Han, In-Wha Kim, Jung Mi Oh and Hyoung Jin Kang
Pharmaceutics 2023, 15(12), 2741; https://doi.org/10.3390/pharmaceutics15122741 - 7 Dec 2023
Viewed by 943
Abstract
Mycophenolate mofetil (MMF) is commonly used for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). However, limited population pharmacokinetic (PPK) data are available for pediatric HSCT patients. This study aimed to develop a PPK model and recommend optimal oral MMF [...] Read more.
Mycophenolate mofetil (MMF) is commonly used for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). However, limited population pharmacokinetic (PPK) data are available for pediatric HSCT patients. This study aimed to develop a PPK model and recommend optimal oral MMF dosage in pediatric HSCT patients. This prospective study involved pediatric HSCT patients at a tertiary academic institution. Patients received oral MMF 15–20 mg/kg twice daily for aGVHD prophylaxis and treatment. The PPK analysis was conducted using a nonlinear mixed-effects modeling method. Simulation was performed considering different body surface areas (BSAs) (0.5 m2, 1.0 m2, 1.5 m2) and dosing (400 mg/m2, 600 mg/m2, 900 mg/m2 twice daily). Based on the simulation, an optimal dosage of oral MMF was suggested. A total of 20 patients and 80 samples were included in the PPK model development. A one-compartment model with first-order absorption adequately described the pharmacokinetics of mycophenolic acid (MPA). BSA was a statistically significant covariate on Vd/F. Simulation suggested the optimal dosage of oral MMF as 900 mg/m2 twice daily, respectively. A reliable PPK model was developed with good predictive performance. This model-informed optimal MMF dosage in pediatric HSCT patients can provide valuable dosing guidance in real-world clinical practice. Full article
(This article belongs to the Special Issue Optimizing Drug Safety and Efficacy: Pharmacokinetic Modeling)
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