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Biomedicines
Special Issues
Pharmacokinetics and Pharmacodynamics of Therapeutic Biologics
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Pharmacokinetics and Pharmacodynamics of Therapeutic Biologics

A special issue of Biomedicines (ISSN 2227-9059). This special issue belongs to the section "Drug Discovery, Development and Delivery".

Deadline for manuscript submissions: 30 September 2024 | Viewed by 1410

Special Issue Editor

Dr. Xiaoyu Yan

E-Mail Website
Guest Editor
School of Pharmacy, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong
Interests: pharmacokinetics and pharmacodynamics of erythropoiesis-stimulating agents; pharmacokinetics and pharmacodynamics of therapeutic mAb; pharmacokinetic modeling; pharmacokinetic-pharmacodynamic modeling; model-informed drug development

Special Issue Information

Dear Colleagues,

The Special Issue, “Pharmacokinetics and Pharmacodynamics of Therapeutic Biologics”, will focus on the pharmacokinetics and pharmacodynamics of biologics (proteins and peptides) such as therapeutic growth factors and antibody-based therapeutics, including monoclonal antibodies, bispecific antibodies, antibody–drug conjugates, fragment antibodies, etc.

Therapeutic biologics are an important class of drugs used to treat a wide range of diseases. They have some unique pharmacokinetics (PK) and pharmacodynamics (PD) properties due to their molecular complexity. This Special Issue aims to provide an up-to-date overview of the latest research in this area, highlighting advances in our understanding of the PK and PD of therapeutic biologics, and identifying key areas for future research.

This Special Issue is open for basic to clinical research, or a multidisciplinary approach, and will also cover original articles and reviews on the following topics:

  • Determinants of PK and PD of biologics: This subcategory will focus on the study of various factors such as size, molecular structure, route of administrations, formulation, target binding, immune response, etc., on the PK and PD on biologics.
  • PK/PD and PBPK modeling: This subcategory will focus on the use of mathematical models to describe the PK and PD of biologics, and to optimize dosing regimens for different patient populations.
  • Clinical pharmacology: This subcategory will examine the results of clinical trials investigating the PK, PD, safety, and tolerability of biologics.
  • Novel technologies: This subcategory will explore the latest technological advances in the study of PK and PD of biologics.

Dr. Xiaoyu Yan
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. Biomedicines 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

  • pharmacokinetics
  • pharmacodynamics
  • PK/PD modeling
  • PBPK modeling
  • mAb
  • ADC
  • pharmacometrics

Published Papers (1 paper)

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Research

12 pages, 1770 KiB  
Article
Population Pharmacokinetic Model of Adalimumab Based on Prior Information Using Real World Data
by Silvia Marquez-Megias, Ricardo Nalda-Molina, Patricio Más-Serrano and Amelia Ramon-Lopez
Biomedicines 2023, 11(10), 2822; https://doi.org/10.3390/biomedicines11102822 - 18 Oct 2023
Viewed by 968
Abstract
Adalimumab is a fully human monoclonal antibody used for the treatment of inflammatory bowel disease (IBD). Due to its considerably variable pharmacokinetics and the risk of developing antibodies against adalimumab, it is highly recommended to use a model-informed precision dosing approach. The aim [...] Read more.
Adalimumab is a fully human monoclonal antibody used for the treatment of inflammatory bowel disease (IBD). Due to its considerably variable pharmacokinetics and the risk of developing antibodies against adalimumab, it is highly recommended to use a model-informed precision dosing approach. The aim of this study is to develop a population pharmacokinetic (PopPK) model of adalimumab for patients with IBD based on a literature model (reference model) to be used in the clinical setting. A retrospective observational study with 54 IBD patients was used to develop two different PopPK models based on the reference model. One of the developed models estimated the pharmacokinetic population parameters (estimated model), and the other model incorporated informative priors (prior model). The models were evaluated with bias and imprecision. Clinical impact was also assessed, evaluating the differences in dose interventions. The developed models included the albumin as a continuous covariate on apparent clearance. The prior model was superior to the estimated model in terms of bias, imprecision and clinical impact on the target population. In conclusion, the prior model adequately characterized adalimumab PK in the studied population and was better than the reference model in terms of predictive performance and clinical impact. Full article
(This article belongs to the Special Issue Pharmacokinetics and Pharmacodynamics of Therapeutic Biologics)
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Planned Papers

The below list represents only planned manuscripts. Some of these manuscripts have not been received by the Editorial Office yet. Papers submitted to MDPI journals are subject to peer-review.

Title: Upholding or Breaking the Law of Superposition in Pharmacokinetics: A practical guide

Authors: Malaz Yousef, Jaime A. Yáñez, Raimar Lobenberg, Neal M. Davies*

 

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