Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval—A Case Study Using Levonorgestrel
Background: The development of long-acting products of a characterized drug substance is of great interest. It is possible to support the development of these products with available clinical data by matching the exposure to a predefined bracket of a minimal concentration for efficacy and a maximal...
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| Autors principals: | , , , , , , |
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| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
MDPI AG
2024-12-01
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| Col·lecció: | Pharmaceuticals |
| Matèries: | |
| Accés en línia: | https://www.mdpi.com/1424-8247/17/12/1640 |
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