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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2021
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| 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 |