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Pharmaceutics
Special Issues
Model-Informed Drug Discovery and Development—Volume II
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Special Issue "Model-Informed Drug Discovery and Development—Volume II"

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

Deadline for manuscript submissions: 20 July 2023 | Viewed by 832

Special Issue Editor

Prof. Dr. Yu Chul Kim

E-Mail Website
Guest Editor
Department of Pharmaceutical Engineering, Inje University, Gimhae 50834, Korea
Interests: pharmacokinetics; drug metabolism; drug–drug interaction; PK/PD; modeling and simulation; PBPK; data analysis
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The usefulness of modeling and simulation (M&S) technology has been verified in a variety of academic and industrial fields. M&S has also expanded its application into the pharmaceutical industry since started being used during drug development and regulatory approval processes as a method to overcome the low productivity of new drug development. Currently, the M&S approach is utilized in almost all stages of drug discovery and development and as a regulatory process evolving from the concept of “model-based” to “model-informed”. Overall, model-informed decision making helps to increase success rates in drug development.

This Special Issue volume II aims to highlight the latest research activities using M&S from all the stages of drug discovery and development, which include PK/PD modeling, PBPK, pharmacometrics, systems pharmacology, etc. We invite researchers to submit original research articles and reviews in this field.

Prof. Dr. Yu Chul Kim
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 2600 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

  • modeling and simulation
  • PK/PD
  • PBPK
  • pharmacometrics
  • systems pharmacology
  • drug discovery and development

Published Papers (1 paper)

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Research

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Article
Application of Physiologically Based Pharmacokinetic Modeling to Predict Drug–Drug Interactions between Elexacaftor/Tezacaftor/Ivacaftor and Tacrolimus in Lung Transplant Recipients
by
Eunjin Hong
,
Eugeniu Carmanov
,
Alan Shi
,
Peter S. Chung
,
Adupa P. Rao
,
Kevin Forrester
and
Paul M. Beringer
Pharmaceutics 2023, 15(5), 1438; https://doi.org/10.3390/pharmaceutics15051438 - 08 May 2023
Viewed by 495
Abstract
Elexacaftor/tezacaftor/ivacaftor (ETI) treatment has potential benefits in lung transplant recipients, including improvements in extrapulmonary manifestations, such as gastrointestinal and sinus disease; however, ivacaftor is an inhibitor of cytochrome P450 3A (CYP3A) and may, therefore, pose a risk for elevated systemic exposure to tacrolimus. [...] Read more.
Elexacaftor/tezacaftor/ivacaftor (ETI) treatment has potential benefits in lung transplant recipients, including improvements in extrapulmonary manifestations, such as gastrointestinal and sinus disease; however, ivacaftor is an inhibitor of cytochrome P450 3A (CYP3A) and may, therefore, pose a risk for elevated systemic exposure to tacrolimus. The aim of this investigation is to determine the impact of ETI on tacrolimus exposure and devise an appropriate dosing regimen to manage the risk of this drug–drug interaction (DDI). The CYP3A-mediated DDI of ivacaftor–tacrolimus was evaluated using a physiologically based pharmacokinetic (PBPK) modeling approach, incorporating CYP3A4 inhibition parameters of ivacaftor and in vitro enzyme kinetic parameters of tacrolimus. To further support the findings in PBPK modeling, we present a case series of lung transplant patients who received both ETI and tacrolimus. We predicted a 2.36-fold increase in tacrolimus exposure when co-administered with ivacaftor, which would require a 50% dose reduction of tacrolimus upon initiation of ETI treatment to avoid the risk of elevated systemic exposure. Clinical cases (N = 13) indicate a median 32% (IQR: −14.30, 63.80) increase in the dose-normalized tacrolimus trough level (trough concentration/weight-normalized daily dose) after starting ETI. These results indicate that the concomitant administration of tacrolimus and ETI may lead to a clinically significant DDI, requiring the dose adjustment of tacrolimus. Full article
(This article belongs to the Special Issue Model-Informed Drug Discovery and Development—Volume II)
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