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...

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Detalles Bibliográficos

Autores principales:	Chen, Jiayi, Zhao, Zhifeng, Wang, Xinyu, Huang, Jingjun
Formato:	Capítulo de libro
Lenguaje:	inglés
Publicado:	IntechOpen 2023
Materias:	Health Sciences
Acceso en línea:	https://www.intechopen.com/chapters/86425
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