Efficient simulation of clinical target response surfaces.


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:
04 2022
Historique:
revised: 18 01 2022
received: 24 11 2021
accepted: 14 02 2022
pubmed: 25 2 2022
medline: 16 4 2022
entrez: 24 2 2022
Statut: ppublish

Résumé

Simulation of combination therapies is challenging due to computational complexity. Either a simple model is used to simulate the response for many combinations of concentration to generate a response surface but parameter variability and uncertainty are neglected and the concentrations are constant-the link to the doses to be administered is difficult to make-or a population pharmacokinetic/pharmacodynamic model is used to predict the response to combination therapy in a clinical trial taking into account the time-varying concentration profile, interindividual variability (IIV), and parameter uncertainty but simulations are limited to only a few selected doses. We devised new algorithms to efficiently search for the combination doses that achieve a predefined efficacy target while taking into account the IIV and parameter uncertainty. The result of this method is a response surface of confidence levels, indicating for all dose combinations the likelihood of reaching the specified efficacy target. We highlight the importance to simulate across a population rather than focus on an individual. Finally, we provide examples of potential applications, such as informing experimental design.

Identifiants

pubmed: 35199969
doi: 10.1002/psp4.12779
pmc: PMC9007598
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

512-523

Informations de copyright

© 2022 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.

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Auteurs

Daniel Lill (D)

IntiQuan GmbH, Basel, Switzerland.
Institute of Physics, University of Freiburg, Freiburg, Germany.

Anne Kümmel (A)

IntiQuan GmbH, Basel, Switzerland.

Venelin Mitov (V)

IntiQuan GmbH, Basel, Switzerland.

Daniel Kaschek (D)

IntiQuan GmbH, Basel, Switzerland.

Nathalie Gobeau (N)

Medicines for Malaria Venture, Geneva, Switzerland.

Henning Schmidt (H)

IntiQuan GmbH, Basel, Switzerland.

Jens Timmer (J)

Institute of Physics, University of Freiburg, Freiburg, Germany.
Centre for Integrative Biological Signalling Studies (CIBSS), University of Freiburg, Freiburg, Germany.
Freiburg Center for Data Analysis and Modelling (FDM), University of Freiburg, Freiburg, Germany.

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Classifications MeSH