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Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region
The Latin America region comprises several countries that do not follow harmonized regulatory requirements for drug product (DP) marketing authorization applications (MAA), resulting in customized registration dossiers for each country. Here, we established a core dossier for multiple MAA in the Lat...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Frontiers Media S.A.
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10229127/ https://www.ncbi.nlm.nih.gov/pubmed/37261120 http://dx.doi.org/10.3389/fmed.2023.1102452 |