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Pharmaceutics
Special Issues
Population Pharmacokinetics and Its Clinical Applications
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Population Pharmacokinetics and Its Clinical Applications

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

Deadline for manuscript submissions: 31 August 2024 | Viewed by 652

Special Issue Editors

Prof. Dr. Katarina Vučićević

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Guest Editor
Department of Pharmacokinetics and Clinical Pharmacy, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia
Interests: clinical pharmacokinetics; population PKPD models; pharmacometrics; TDM; model-informed dosing optimization; NONMEM
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Branislava Miljković

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Guest Editor
Department of Pharmacokinetics and Clinical Pharmacy, Faculty of Pharmacy, University of Belgrade, 11221 Belgrade, Serbia
Interests: clinical pharmacokinetics; variability in pharmacokinetics; drug-drug interactions; TDM

Special Issue Information

Dear Colleagues,

Population pharmacokinetics, a field within pharmacokinetics, investigates the variability of drug concentrations between individuals in a selected population. It has gained considerable interest in recent years due to its potential to optimize drug dosing, improve therapeutic outcomes, and minimize adverse effects. This Special Issue focuses on the recent advances in population pharmacokinetics, with an emphasis on the clinical applications for personalized dosing in various therapeutic areas and special populations.

I am pleased to invite you to contribute original research articles, reviews, and methodological papers to this Special Issue entitled Population Pharmacokinetics and Its Clinical Applications. This issue aims to address the increasing demand for personalized medicine and optimized drug therapies. Population pharmacokinetics, a field within pharmacokinetics, investigates the variability in drug concentration among individuals in a selected population. It has gained significant interest in recent years due to its potential to support drug dosing optimization while enhancing therapeutic outcomes and minimizing adverse effects.

This Special Issue focuses on the recent advances in population pharmacokinetics, with an emphasis on the clinical applications for personalized dosing in various therapeutic areas and special populations. The scope of this Special Issue covers a broad range of topics related to population pharmacokinetics, including but not limited to the following: methodological advances in population modeling algorithms and simulation techniques; disease-specific applications of population pharmacokinetics in various therapeutic areas such as infectious diseases, inflammatory bowel diseases, and psychiatric disorders to predict individual patient responses and personalize treatment strategies; pharmacokinetic considerations for special populations such as pediatric, elderly, and patients with comorbidities; the integration of pharmacogenetic data into population pharmacokinetic models; and the potential for genotype-guided dosing strategies. The articles compiled in this Special Issue highlight the evolving landscape of population pharmacokinetics and its role in drug development and clinical practice.

I would like to extend my gratitude to all the authors who have chosen this Special Issue as a platform to publish their research findings. I look forward to receiving your contributions.

Prof. Dr. Katarina Vučićević
Prof. Dr. Branislava Miljković
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

  • model-informed precision dosing (MIPD)
  • therapeutic drug monitoring (TDM)
  • dosing adjustments
  • special populations
  • nonlinear mixed-effects modeling (NONMEM)
  • PK/PD models

Published Papers (2 papers)

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Research

12 pages, 1602 KiB  
Article
Development of a Web Application for Simulating Plasma Drug Concentrations in Patients with Zolpidem Intoxication
by Hwa Jun Cha, Sungpil Han, Kwan Cheol Pak and Hyungsub Kim
Pharmaceutics 2024, 16(5), 689; https://doi.org/10.3390/pharmaceutics16050689 - 20 May 2024
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Abstract
Zolpidem is a widely prescribed hypnotic Z-drug used to treat short-term insomnia. However, a growing number of individuals intentionally overdose on these drugs. This study aimed to develop a predictive tool for physicians to assess patients with zolpidem overdose. A population pharmacokinetic (PK) [...] Read more.
Zolpidem is a widely prescribed hypnotic Z-drug used to treat short-term insomnia. However, a growing number of individuals intentionally overdose on these drugs. This study aimed to develop a predictive tool for physicians to assess patients with zolpidem overdose. A population pharmacokinetic (PK) model was established using digitized data obtained from twenty-three healthy volunteers after a single oral administration of zolpidem. Based on the final PK model, a web application was developed using open-source R packages such as rxode2, nonmem2rx, and shiny. The final model was a one-compartment model with first-order absorption and elimination with PK parameters, including clearance (CL, 16.9 L/h), absorption rate constant (Ka, 5.41 h−1), volume of distribution (Vd, 61.7 L), and lag time (ALAG, 0.394 h). Using the established population PK model in the current study, we developed a web application that enables users to simulate plasma zolpidem concentrations and visualize their profiles. This user-friendly web application may provide essential clinical information to physicians, ultimately helping in the management of patients with zolpidem intoxication. Full article
(This article belongs to the Special Issue Population Pharmacokinetics and Its Clinical Applications)
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13 pages, 1219 KiB  
Article
Integrating Clopidogrel’s First-Pass Effect in a Joint Semi-Physiological Population Pharmacokinetic Model of the Drug and Its Inactive Carboxylic Acid Metabolite
by Zorica Pejčić, Valentina Topić Vučenović, Branislava Miljković and Katarina M. Vučićević
Pharmaceutics 2024, 16(5), 685; https://doi.org/10.3390/pharmaceutics16050685 - 20 May 2024
Viewed by 208
Abstract
Clopidogrel (CLO), a pro-drug for preventing thrombotic events, undergoes rapid absorption and extensive metabolism, with approximately 85–90% converted to an inactive carboxylic acid metabolite (CLO-CA) and the remaining to an active thiol (CLO-TH). Few pharmacokinetic models for the drug and its metabolites exist, [...] Read more.
Clopidogrel (CLO), a pro-drug for preventing thrombotic events, undergoes rapid absorption and extensive metabolism, with approximately 85–90% converted to an inactive carboxylic acid metabolite (CLO-CA) and the remaining to an active thiol (CLO-TH). Few pharmacokinetic models for the drug and its metabolites exist, with most focusing on CLO-TH. Although CLO-CA is inactive, its predominant (compared to its parent drug and metabolites) presence in plasma underscores the importance of characterizing its formation and pharmacokinetic profile. This study aimed to characterize the process of the absorption of CLO and its conversion to CLO-CA via developing a population pharmacokinetic model. Individual participants’ data from two bioequivalence studies were utilized. Extensive blood samples were collected at predetermined intervals, including 841 concentrations of CLO and 1149 of CLO-CA. A nonlinear, mixed-effects modelling approach using NONMEM® software (v 7.5) was applied. A one-compartment model was chosen for CLO, while a two-compartment proved optimal for CLO-CA. Absorption from the depot compartment was modeled via two transit compartments, incorporating transit rate constants (Ktr). A semi-physiological model explained the first-pass effect of CLO, integrating a liver compartment. The estimated mean transit times (MTTs) for the studies were 0.470 and 0.410 h, respectively. The relative bioavailability for each study’s generic medicine compared to the reference were 1.08 and 0.960, respectively. Based on the estimated parameters, the fractions metabolized to inactive metabolites (FiaM_st1 and FiaM_st2) were determined to be 87.27% and 86.87% for the two studies, respectively. The appropriateness of the final model was confirmed. Our model offers a robust framework for elucidating the pharmacokinetic profiles of CLO and CLO-CA. Full article
(This article belongs to the Special Issue Population Pharmacokinetics and Its Clinical Applications)
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