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...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-11-01
|
| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.12708 |
| _version_ | 1818402734673494016 |
|---|---|
| author | Ine Skottheim Rusten Flora Tshinanu Musuamba |
| author_facet | Ine Skottheim Rusten Flora Tshinanu Musuamba |
| author_sort | Ine Skottheim Rusten |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-14T08:13:04Z |
| format | Article |
| id | doaj.art-22f9226774ba4d07af13a0fb0501d239 |
| institution | Directory Open Access Journal |
| issn | 2163-8306 |
| language | English |
| last_indexed | 2024-12-14T08:13:04Z |
| publishDate | 2021-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | CPT: Pharmacometrics & Systems Pharmacology |
| spelling | doaj.art-22f9226774ba4d07af13a0fb0501d2392022-12-21T23:10:02ZengWileyCPT: Pharmacometrics & Systems Pharmacology2163-83062021-11-0110111281129610.1002/psp4.12708Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment frameworkIne Skottheim Rusten0Flora Tshinanu Musuamba1The Norwegian Medicines Agency Oslo NorwayEMA Modelling and Simulation Working Party Amsterdam The NetherlandsAbstract 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.https://doi.org/10.1002/psp4.12708 |
| spellingShingle | Ine Skottheim Rusten Flora Tshinanu Musuamba Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework CPT: Pharmacometrics & Systems Pharmacology |
| 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 |
| url | https://doi.org/10.1002/psp4.12708 |
| work_keys_str_mv | AT ineskottheimrusten scientificandregulatoryevaluationofempiricalpharmacometricmodelsanapplicationoftheriskinformedcredibilityassessmentframework AT floratshinanumusuamba scientificandregulatoryevaluationofempiricalpharmacometricmodelsanapplicationoftheriskinformedcredibilityassessmentframework |