Utilizing 505(b)(2) Regulatory Pathway for New Drug Applications: An Overview on the Advanced Formulation Approach and Challenges
More than 50% of approved drugs on the market contain poorly water-soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects. This creates a huge opportunity in generating 505(b)(2) products, which address unmet medi...
Guardado en:
| Autores principales: | , , , |
|---|---|
| Formato: | Capítulo de libro |
| Lenguaje: | inglés |
| Publicado: |
IntechOpen
2023
|
| Materias: | |
| Acceso en línea: | https://www.intechopen.com/chapters/86425 |
| Etiquetas: |
Sin Etiquetas, Sea el primero en etiquetar este registro!
|