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

Abstract 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 com...

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Autores principales:	Ine Skottheim Rusten, Flora Tshinanu Musuamba
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/22f9226774ba4d07af13a0fb0501d239
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spelling	oai:doaj.org-article:22f9226774ba4d07af13a0fb0501d2392021-11-15T18:41:53ZScientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework2163-830610.1002/psp4.12708https://doaj.org/article/22f9226774ba4d07af13a0fb0501d2392021-11-01T00:00:00Zhttps://doi.org/10.1002/psp4.12708https://doaj.org/toc/2163-8306Abstract 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.Ine Skottheim RustenFlora Tshinanu MusuambaWileyarticleTherapeutics. PharmacologyRM1-950ENCPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 11, Pp 1281-1296 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950
spellingShingle	Therapeutics. Pharmacology RM1-950 Ine Skottheim Rusten Flora Tshinanu Musuamba Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
description	Abstract 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.
format	article
author	Ine Skottheim Rusten Flora Tshinanu Musuamba
author_facet	Ine Skottheim Rusten Flora Tshinanu Musuamba
author_sort	Ine Skottheim Rusten
title	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_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_sort	scientific and regulatory evaluation of empirical pharmacometric models: an application of the risk informed credibility assessment framework
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/22f9226774ba4d07af13a0fb0501d239
work_keys_str_mv	AT ineskottheimrusten scientificandregulatoryevaluationofempiricalpharmacometricmodelsanapplicationoftheriskinformedcredibilityassessmentframework AT floratshinanumusuamba scientificandregulatoryevaluationofempiricalpharmacometricmodelsanapplicationoftheriskinformedcredibilityassessmentframework
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Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework

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