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Pharmaceutics
Special Issues
Advances in Pharmacokinetics and Drug-Drug Interactions
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Advances in Pharmacokinetics and Drug-Drug Interactions

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 497

Special Issue Editors

Dr. Keumhan Noh

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Guest Editor
Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney Street, Cambridge, MA 02142, USA
Interests: PKPD modeling; drug-drug interaction; human dose projection; IVIVC
Dr. Jong Hwa Lee

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Guest Editor
Bioanalysis and Pharmacokinetic Research Group, Korea Institute of Toxicology, Daejeon 34114, Republic of Korea
Interests: toxico-/pharmacokinetics; bioanalysis; ADME; metabolism; method validation

Special Issue Information

Dear Colleagues,

Pharmacokinetics is a discipline that explains the absorption, distribution, metabolism, and excretion (ADME) of drugs over time, with the goal of understanding how our body responds to drugs. The ADME of the drug could be affected by concurrently administered drugs called drug-drug interaction (DDI). Such drug interactions can increase or decrease the systemic exposure of the drug and even lead to unexpected side effects of the drug. Therefore, understanding of DDI potential is critical not only for successful drug development but also for the safe and effective use of a drug in clinical practice. Due to this reason, regulatory agencies require pharmaceutical developers to evaluate DDI potential according to their guidelines. Multiple approaches, including in vitro, in vivo, and in silico methods, have been applied to assess DDI potential throughout the drug discovery and development processes. The impact of DDI on PK/PD of a compound can also be evaluated in clinical trials, if necessary.

In this special issue, we would like to cover manuscripts that describe basic, applied, and in vitro-in vivo experimental results, as well as in silico modeling and simulation approach to highlight recent advances in DMPK and clinical pharmacology for DDI evaluation and prediction. We welcome the submission of original and review articles on DDI.

Dr. Keumhan Noh
Dr. Jong-Hwa Lee
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-drug interaction
  • time dependent inhibition
  • CYP inhibition/induction
  • transporter inhibition/induction
  • ADME
  • physiologically based pharmacokinetic (PBPK) model

Published Papers (1 paper)

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Research

12 pages, 1071 KiB  
Article
Exploring the Impact of Hepatic Impairment on Pralsetinib Pharmacokinetics
by Kit Wun Kathy Cheung, Yang Tang, Doreen Anders, Teresa Barata, Astrid Scalori, Priya Agarwal, Rucha Sane and Sravanthi Cheeti
Pharmaceutics 2024, 16(4), 564; https://doi.org/10.3390/pharmaceutics16040564 - 20 Apr 2024
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Abstract
Pralsetinib is a kinase inhibitor indicated for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer. Pralsetinib is primarily eliminated by the liver and hence hepatic impairment (HI) is likely alter its pharmacokinetics (PK). Mild HI has [...] Read more.
Pralsetinib is a kinase inhibitor indicated for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer. Pralsetinib is primarily eliminated by the liver and hence hepatic impairment (HI) is likely alter its pharmacokinetics (PK). Mild HI has been shown to have minimal impact on the PK of pralsetinib. This hepatic impairment study aimed to determine the pralsetinib PK, safety and tolerability in subjects with moderate and severe HI, as defined by the Child–Pugh and National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) classification systems, in comparison to subjects with normal hepatic function. Based on the Child–Pugh classification, subjects with moderate and severe HI had similar systemic exposure (area under the plasma concentration time curve from time 0 to infinity [AUC0–∞]) to pralsetinib, with AUC0–∞ geometric mean ratios (GMR) of 1.12 and 0.858, respectively, compared to subjects with normal hepatic function. Results based on the NCI-ODWG classification criteria were comparable; the AUC0–∞ GMR were 1.22 and 0.858, respectively, for subjects with moderate and severe HI per NCI-ODWG versus those with normal hepatic function. These results suggested that moderate and severe hepatic impairment did not have a meaningful impact on the exposure to pralsetinib, thus not warranting a dose adjustment in this population. Full article
(This article belongs to the Special Issue Advances in Pharmacokinetics and Drug-Drug Interactions)
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