The Role of Metabolites in Translational and Clinical Pharmacology

A special issue of Metabolites (ISSN 2218-1989). This special issue belongs to the section "Pharmacology and Drug Metabolism".

Deadline for manuscript submissions: 15 July 2024 | Viewed by 747

Special Issue Editors

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Guest Editor
Transporters & In Vitro Technologies, ADMET & BA, Merck & Co. Inc., West Point, PA 19486, USA
Interests: drug metabolism & transport; pharmacokinetics; drug-drug in-teractions; special populations, PBPK and PK/PD modeling & simulation

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Guest Editor
Office of Clinical Pharmacology, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Interests: drug-drug interactions; drug-food interactions; metabolism; transport; PBPK modeling; clinical pharmacology; regulatory science

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Guest Editor
Certara Strategic Consulting, Integrated Drug Development, Certara, Princeton, NJ 08540, USA
Interests: drug-drug interactions; pediatrics; metabolism; transport; PBPK modeling; clinical pharmacology; special populations, phar-macogenetics; regulatory science; MIDD

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Guest Editor
Department of Medicinal Chemistry, University of Washington, Seattle, WA 98195, USA
Interests: drug metabolism; DDI; reactive metabolites; protein-drug ad-ducts; time dependent inhibition; CYP2J2; S-Methyl transferases in health and disease

Special Issue Information

Dear Colleagues,

Drug metabolism can lead to the formation of pharmacologically active, inactive, or reactive metabolites. Factors, including intrinsic (e.g., disease, age and genetics) or extrinsic (e.g., co-medication and food), can affect the pharmacokinetics (PK) of active drug metabolites and consequently their pharmacodynamics (PD). In addition, drug metabolites can impact the activity of drug-metabolizing enzyme- or transporter (DMET) proteins, leading to changes in the exposure of co-administered drugs and raising concerns about their safety and efficacy, especially for narrow-therapeutic index drugs. Therefore, regulatory agencies emphasize studying the PK, PK/PD, and drug–drug interaction (DDI) potential of major drug metabolites.

This Special Issue aims to provide a comprehensive overview of the importance of drug metabolites in drug discovery and development within translational and clinical pharmacology domains. We invite original research articles, reviews, and short communications related to the field of metabolites. Interested authors are encouraged to send pre-submission inquiries and discuss potential fee waivers (depending on the merit).

Topics of interest include, but are not limited to, the following areas:

  • Absorption, distribution, metabolism, and excretion (ADME) or PK studies of drug metabolites.
  • In vitro or in vivo evaluation of drug metabolites as substrates or perpetrators (inhibitors or inducers) of DMET proteins.
  • Prediction of PK of drug metabolites in healthy or special populations using physiologically based pharmacokinetic (PBPK) models.
  • Prediction of the DDI potential of drug metabolites using basic, static mechanistic, or dynamic PBPK models.
  • Endogenous biomarkers for assessing the DMET-mediated DDI potential.
  • Use of metabolite monitoring in DDI studies to improve the mechanistic interpretation of results.
  • Mechanistic PK and PK/PD modeling of drug metabolites or parent metabolites.

Dr. Mayur K. Ladumor
Dr. Xinning Yang
Dr. Eva Gil Berglund
Prof. Dr. Rheem A. Totah
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at 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. Metabolites 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 2700 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.


  • metabolism
  • transport
  • ADME
  • PK
  • DDI
  • special populations
  • endogenous metabolite biomarker
  • PBPK and PK/PD modeling

Published Papers

This special issue is now open for submission.
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