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Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework

Empirical pharmacometric models are part of practically every regulatory submission for a new drug. The use of the models often exceeds descriptory roles and this change in their context of use increase the requirements on the evidence to support that they are credible. However, when it comes to ass...

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Detalles Bibliográficos
Autores principales: Skottheim Rusten, Ine, Musuamba, Flora Tshinanu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592505/
https://www.ncbi.nlm.nih.gov/pubmed/34514745
http://dx.doi.org/10.1002/psp4.12708
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author Skottheim Rusten, Ine
Musuamba, Flora Tshinanu
author_facet Skottheim Rusten, Ine
Musuamba, Flora Tshinanu
author_sort Skottheim Rusten, Ine
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description Empirical pharmacometric models are part of practically every regulatory submission for a new drug. The use of the models often exceeds descriptory roles and this change in their context of use increase the requirements on the evidence to support that they are credible. However, when it comes to assessing the trust in a model for a specific application, current tools are skewed to technical aspects and guidance documents often focused on model reporting or the iterative learning loops of model informed drug development (MIDD). There is an unmet need for a holistic tool that provide an end‐to‐end link from the initial question to the model‐informed decision. We suggest the risk‐informed credibility framework can be used for this purpose and offers strong support for the pharmacometrics models. We also introduce two tables for explicit description of key attributes of the model evaluation to facilitate and streamline the communication between stakeholders.
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spelling pubmed-85925052021-11-22 Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework Skottheim Rusten, Ine Musuamba, Flora Tshinanu CPT Pharmacometrics Syst Pharmacol White Paper Empirical pharmacometric models are part of practically every regulatory submission for a new drug. The use of the models often exceeds descriptory roles and this change in their context of use increase the requirements on the evidence to support that they are credible. However, when it comes to assessing the trust in a model for a specific application, current tools are skewed to technical aspects and guidance documents often focused on model reporting or the iterative learning loops of model informed drug development (MIDD). There is an unmet need for a holistic tool that provide an end‐to‐end link from the initial question to the model‐informed decision. We suggest the risk‐informed credibility framework can be used for this purpose and offers strong support for the pharmacometrics models. We also introduce two tables for explicit description of key attributes of the model evaluation to facilitate and streamline the communication between stakeholders. John Wiley and Sons Inc. 2021-10-08 2021-11 /pmc/articles/PMC8592505/ /pubmed/34514745 http://dx.doi.org/10.1002/psp4.12708 Text en © 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle White Paper
Skottheim Rusten, Ine
Musuamba, Flora Tshinanu
Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title_full Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title_fullStr Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title_full_unstemmed Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title_short Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
title_sort scientific and regulatory evaluation of empirical pharmacometric models: an application of the risk informed credibility assessment framework
topic White Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592505/
https://www.ncbi.nlm.nih.gov/pubmed/34514745
http://dx.doi.org/10.1002/psp4.12708
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