Development and application of a PBPK modeling strategy to support antimalarial drug development.


Journal

CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011

Informations de publication

Date de publication:
09 2023
Historique:
revised: 26 05 2023
received: 27 02 2023
accepted: 28 06 2023
medline: 20 9 2023
pubmed: 17 8 2023
entrez: 17 8 2023
Statut: ppublish

Résumé

As part of a collaboration between Medicines for Malaria Venture (MMV), Certara UK and Monash University, physiologically-based pharmacokinetic (PBPK) models were developed for 20 antimalarials, using data obtained from standardized in vitro assays and clinical studies within the literature. The models have been applied within antimalarial drug development at MMV for more than 5 years. During this time, a strategy for their impactful use has evolved. All models are described in the supplementary material and are available to researchers. Case studies are also presented, demonstrating real-world development and clinical applications, including the assessment of the drug-drug interaction liability between combination partners or with co-administered drugs. This work emphasizes the benefit of PBPK modeling for antimalarial drug development and decision making, and presents a strategy to integrate it into the research and development process. It also provides a repository of shared information to benefit the global health research community.

Identifiants

pubmed: 37587640
doi: 10.1002/psp4.13013
pmc: PMC10508484
doi:

Substances chimiques

Antimalarials 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1335-1346

Informations de copyright

© 2023 Certara UK and The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

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Auteurs

Nada Abla (N)

Medicines for Malaria Venture, Geneva, Switzerland.

Eleanor Howgate (E)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Karen Rowland-Yeo (K)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Maurice Dickins (M)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Mackenzie C Bergagnini-Kolev (MC)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Kuan-Fu Chen (KF)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Savannah McFeely (S)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Jennifer J Bonner (JJ)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Laura G A Santos (LGA)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Nathalie Gobeau (N)

Medicines for Malaria Venture, Geneva, Switzerland.

Howard Burt (H)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Zoe Barter (Z)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

Hannah M Jones (HM)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

David Wesche (D)

Certara USA, Integrated Drug Development, Grand Rapids, Michigan, USA.

Susan A Charman (SA)

Monash University, Melbourne, Victoria, Australia.

Jörg J Möhrle (JJ)

Medicines for Malaria Venture, Geneva, Switzerland.

Jeremy N Burrows (JN)

Medicines for Malaria Venture, Geneva, Switzerland.

Lisa M Almond (LM)

Certara UK Ltd, Simcyp Division, Sheffield, UK.

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